Solriamfetol is a dopamine and norepinephrine reuptake inhibitor approved to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. In patients with obstructive sleep apnea, the underlying airway obstruction should be treated (e.g., with CPAP) for at least 1 month prior to initiating solriamfetol. Increases in blood pressure, heart rate, and the development or worsening of psychiatric symptoms such as anxiety, insomnia, and irritability are possible during solriamfetol use. Blood pressure and heart rate should be assessed before initiating treatment with solriamfetol and throughout treatment with the drug.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
-Administer by mouth upon awakening. May be administered with or without food.
-Avoid administration within 9 hours of planned bedtime due to the potential for sleep interference if taken too late in the day.
-The 75 mg tablets are scored and can be split in half to give a 37.5 mg dose.
During clinical trials in adults with narcolepsy or obstructive sleep apnea, the following centrally-mediated (CNS) effects occurred in at least 2% of solriamfetol-treated patients and more frequently than in placebo-treated patients: insomnia (5%), dizziness (2%), and headache (7% to 16%). CNS effects observed during other premarketing evaluations of solriamfetol included teeth grinding (bruxism) and tremor. Headache was considered a dose-dependent adverse reaction.
During clinical trials in adults with narcolepsy or obstructive sleep apnea, the following adverse psychiatric effects occurred in at least 2% of solriamfetol-treated patients and more frequently than in placebo-treated patients: anxiety (2% to 7%), irritability (3%), and feeling jittery (3%). Psychiatric effects observed during other premarketing evaluations of solriamfetol included agitation, restlessness, and disturbances in attention. Anxiety was considered a dose-dependent adverse reaction. Psychiatric effects that resulted in treatment discontinuation at a higher rate in patients who received solriamfetol than placebo included anxiety (less than 1%) and restlessness (less than 1%). Because psychiatric effects have been reported during solriamfetol administration and the drug has not been studied in patients with a history of psychosis (e.g., schizophrenia) or bipolar disorder (e.g., mania), caution is recommended in these populations. Patients receiving solriamfetol should be observed for the emergence or worsening of psychiatric symptoms. If psychiatric symptoms develop during treatment with solriamfetol, consider a dose reduction or discontinuation of the drug.
During clinical trials in adults with narcolepsy or obstructive sleep apnea, the following adverse gastrointestinal (GI) effects occurred in at least 2% of solriamfetol-treated patients and more frequently than in placebo-treated patients: decreased appetite (6% to 9%), nausea (5% to 8%), diarrhea (4% to 5%), abdominal pain (3%), xerostomia (2% to 4%), and constipation (3%). Adverse GI effects observed during other premarketing evaluations of solriamfetol included weight loss and vomiting. Nausea, decreased appetite, diarrhea, and xerostomia were considered dose-dependent adverse reactions.
During clinical trials in adults with narcolepsy or obstructive sleep apnea, palpitations occurred in 2% to 3% of solriamfetol-treated patients and more frequently than in placebo-treated patients. Palpitations resulted in treatment discontinuation at a higher rate in patients who received solriamfetol (less than 1%) than placebo. Solriamfetol can cause a dose-related increase in systolic blood pressure, diastolic blood pressure, and heart rate in patients with or without pre-existing hypertension. During use of FDA approved doses, the maximal mean changes in blood pressure and heart rate from baseline through week 12 of clinical trials were as follows: systolic blood pressure in mmHg (37.5 mg = +4.6; 75 mg = +3.8; 150 mg = +4.9), diastolic blood pressure in mmHg (37.5 mg = +1.9; 75 mg = +3.2; 150 mg = +4.2), and heart rate in beats/minute (37.5 mg = +1.9; 75 mg = +3.7; 150 mg = +4.9). Blood pressure should be assessed before initiating treatment with solriamfetol and monitored regularly thereafter during treatment. If a patient experiences increases in blood pressure or heart rate that cannot be managed with a dose reduction or other medical intervention, consider discontinuation of solriamfetol.
During premarketing evaluations of solriamfetol, adverse respiratory effects including cough and dyspnea were reported; however, the frequencies are unknown and causality to the drug has not been established.
During clinical trials of solriamfetol in adults with narcolepsy or obstructive sleep apnea, hyperhidrosis occurred in 2% of solriamfetol-treated patients and more frequently than in placebo-treated patients. Hyperhidrosis was also observed in other premarketing evaluations of solriamfetol.
During clinical trials in adults with narcolepsy or obstructive sleep apnea, chest discomfort occurred in 2% of solriamfetol-treated patients and more frequently than in placebo-treated patients. Other general disorders observed during premarketing evaluation of solriamfetol included thirst and chest pain (unspecified).
Postmarketing reports of hypersensitivity reactions, such as urticaria and rash (erythematous rash and unspecified), have occurred following the use of solriamfetol. As these reports are voluntary, the incidence of these events is currently unknown.
Due to the CNS stimulant effects of solriamfetol, the drug should be avoided in patients with unstable cardiac disease, serious cardiac arrhythmias, or other serious heart problem (e.g., unstable angina, acute myocardial infarction, valvular heart disease, ventricular dysfunction, heart failure). Solriamfetol can cause a dose-related increase in systolic blood pressure, diastolic blood pressure, and heart rate in patients with or without pre-existing hypertension. Blood pressure should be assessed before initiating treatment with solriamfetol and monitored throughout treatment. If a patient experiences increases in blood pressure or heart rate that cannot be managed with a dose reduction or other medical intervention, consider discontinuation of solriamfetol. Caution is recommended when treating patients at higher risk of a major adverse cardiovascular event (MACE), including patients with cardiac disease, cerebrovascular disease, pre-existing hypertension, and older adult patients. Major adverse cardiovascular events include stroke, myocardial infarction, and cardiovascular death. The magnitude of the increase in absolute risk of a MACE is dependent on the increase in blood pressure and the underlying risk of MACE in the patient population being treated. Many patients with narcolepsy or obstructive sleep apnea have multiple risk factors for MACE, including hypertension, diabetes mellitus, hyperlipidemia, and obesity (high body mass index). Patients with moderate to severe impairment of renal function may be at higher risk of increased blood pressure and heart rate due to a prolonged half-life of solriamfetol in these populations. Use caution with coadministration of other drugs that increase blood pressure and heart rate.
Caution should be exercised when administering solriamfetol to patients with a known history of psychosis (e.g., schizophrenia) or bipolar disorder (e.g., mania). Patients receiving solriamfetol should be observed for the emergence or worsening of psychiatric symptoms. Various adverse psychiatric effects (e.g., agitation, anxiety, insomnia, irritability) have occurred during administration of solriamfetol. In addition, solriamfetol has not been evaluated in patients with psychosis or bipolar disorder. If psychiatric symptoms develop during treatment with solriamfetol, consider a dose reduction or discontinuation of the drug. Patients with moderate to severe renal dysfunction may have a higher risk of developing psychiatric symptoms because of the prolonged half-life of solriamfetol in these populations.
As a CNS stimulant, solriamfetol has the potential for abuse. Drug abuse, misuse, diversion, psychological dependence, physiological dependence, and tolerance have been reported with other psychostimulants. Patients should be carefully evaluated for a recent history of substance abuse, especially those patients with a history of alcoholism or stimulant abuse. Such patients should be observed for signs of misuse or abuse (e.g., frequent prescription refill requests, drug-seeking behavior) if treatment with solriamfetol is required. In a long-term safety and treatment maintenance study, there was no evidence that abrupt discontinuation of solriamfetol resulted in symptoms consistent with physical dependence or withdrawal.
Because solriamfetol is primarily eliminated by the kidneys as the unchanged parent compound, patients with moderate to severe renal impairment (eGFR 15 to 59 mL/minute/1.73 m2) require dosage adjustments. Patients with moderate to severe renal impairment may be at a higher risk of increased blood pressure and heart rate due to a prolonged half-life of solriamfetol in these populations. Use of solriamfetol in patients with renal failure or end-stage renal disease (ESRD) (i.e., eGFR less than 15 mL/minute/1.73 m2) is not recommended.
Limited available human data regarding the use of solriamfetol during pregnancy are not sufficient to adequately assess the risk of any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Results from animal reproductive studies using doses exceeding the maximum recommended human dose (MRHD) of solriamfetol showed fetal harm (e.g., adverse effects on fertility, growth, and development) and maternal toxicity (e.g., hyperactivity, significant decreases in body weight and food consumption, post-implantation loss). Solriamfetol was teratogenic at doses 5 to 19 times the MRHD in animal studies. There is a pregnancy exposure registry to monitor pregnancy outcomes in women exposed to solriamfetol during pregnancy. Healthcare providers are encouraged to enroll patients or assist patients to register online at www.SunosiPregnancyRegistry.com or by calling 1-877-283-6220.
Use solriamfetol during breast-feeding with caution. Available data from a lactation study of 6 healthy lactating women who were between 10 days and 52 weeks postpartum and given a single dose of 150 mg of solriamfetol indicate that solriamfetol is present in human milk. The daily infant dose is 0.112 mg/kg (based on nominal infant weight of 6 kg) and the relative infant dose (RID) is approximately 5.5% of the maternal weight-adjusted dosage. Of the total amount of solriamfetol excreted in breast milk over 72 hours, approximately 78% and 98% were excreted by 8 and 24 hours, respectively, with an apparent mean elimination half-life in breast milk of about 5 hours. Data are insufficient to determine the effects of solriamfetol on breastfed infants or its effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the clinical need for solriamfetol treatment and any potential adverse effects on the breastfed child from the medication or the underlying maternal condition. If use of solriamfetol is required during breast-feeding, the breastfed infant should be monitored for agitation, insomnia, anorexia, and reduced weight gain.
During clinical trial evaluation, no clinically significant differences in safety or effectiveness were observed between geriatric and younger patients. However, because solriamfetol is eliminated primarily through the kidneys as the parent compound, consider lower doses and close monitoring in populations at risk for a decline in renal function, such as the elderly. Due to an age-related decline in renal function, geriatric patients may be at increased risk for solriamfetol-induced adverse effects, such as increased blood pressure, increased heart rate, or psychiatric symptoms. In addition, caution is recommended when treating patients with a higher risk of a major adverse cardiovascular event (MACE), including the elderly. Major adverse cardiovascular events include stroke, myocardial infarction, and cardiovascular death.
Solriamfetol is contraindicated in patients currently receiving MAOI therapy or in patients who have used an MAOI within the past 14 days because of the risk of a hypertensive reaction.
For the treatment of excessive daytime drowsiness associated with narcolepsy:
Oral dosage:
Adults: Initially, 75 mg PO once daily upon awakening. Based on efficacy and tolerability, the dose may be increased to 150 mg after at least 3 days. Max: 150 mg PO once daily. Doses above 150 mg per day do not increase efficacy sufficient to outweigh dose-related adverse reactions. Because the drug is primarily eliminated renally, consider the use of lower doses and close monitoring in patients who are more likely to have decreased renal function, such as the geriatric adult. Periodically evaluate the need for continued treatment. If blood pressure or heart rate increases cannot be managed with dose reduction or medical interventions, consider discontinuation of solriamfetol. Avoid administration within 9 hours of planned bedtime because of the potential for sleep interference.
For the treatment of obstructive sleep apnea:
Oral dosage:
Adults: Initially, 37.5 mg PO once daily upon awakening. If needed, may double the dose at intervals of at least 3 days. Max: 150 mg/day PO. Doses above 150 mg per day do not increase efficacy sufficient to outweigh dose-related adverse reactions. Periodically evaluate the need for continued treatment. If blood pressure or heart rate increases cannot be managed with dose reduction or medical interventions, consider discontinuing solriamfetol. LIMITS OF USE: Solriamfetol is not indicated to treat the underlying airway obstruction. Ensure the underlying airway obstruction is treated (e.g., with continuous positive airway pressure) for at least 1 month before initiating solriamfetol. Non-pharmacological modalities to treat the underlying airway obstruction should be continued during use of solriamfetol.
Maximum Dosage Limits:
-Adults
150 mg/day PO.
-Geriatric
150 mg/day PO.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
eGFR 30 to 59 mL/minute/1.73 m2: Initiate at 37.5 mg PO once daily. May increase to a maximum of 75 mg PO once daily after at least 7 days.
eGFR 15 to 29 mL/minute/1.73 m2: 37.5 mg PO once daily is the recommended initial and maximum daily dose.
eGFR less than 15 mL/minute/1.73 m2: Avoid use.
Intermittent hemodialysis:
In a renal impairment study, an average of 21% of solriamfetol was removed by hemodialysis. Solriamfetol is not recommended in patients with end-stage renal disease.
*non-FDA-approved indication
Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Caffeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Caffeine; Dihydrocodeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Caffeine; Pyrilamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Chlorpheniramine; Phenylephrine : (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Dextromethorphan; Guaifenesin; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Dextromethorphan; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Dextromethorphan; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Guaifenesin; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acetaminophen; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Acrivastine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Amantadine: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as amantadine. Caution is recommended since this combination has not been evaluated.
Amphetamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and amphetamines, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Amphetamine; Dextroamphetamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and amphetamines, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Amphetamines: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and amphetamines, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Angiotensin II: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Apomorphine: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as apomorphine. Caution is recommended since this combination has not been evaluated.
Armodafinil: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and armodafinil, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Articaine; Epinephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Aspirin, ASA; Butalbital; Caffeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Aspirin, ASA; Caffeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Aspirin, ASA; Caffeine; Orphenadrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Benzphetamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and amphetamines, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Bevacizumab: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and bevacizumab. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Bromocriptine: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as bromocriptine. Caution is recommended since this combination has not been evaluated.
Brompheniramine; Dextromethorphan; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Brompheniramine; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Brompheniramine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Brompheniramine; Pseudoephedrine; Dextromethorphan: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Bupivacaine; Epinephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Bupropion: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as bupropion. Caution is recommended since this combination has not been evaluated.
Bupropion; Naltrexone: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as bupropion. Caution is recommended since this combination has not been evaluated.
Butalbital; Acetaminophen; Caffeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Butalbital; Acetaminophen; Caffeine; Codeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Butalbital; Aspirin; Caffeine; Codeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Caffeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated. (Moderate) Patients who regularly consume caffeine-containing foods or beverages may need to limit caffeine intake during solriamfetol treatment. Blood pressure and heart rate should be closely monitored in patients treated with solriamfetol who regularly consume caffeine. Solriamfetol can increase blood pressure and heart rate; caffeine is a stimulant that may cause additive effects on blood pressure or heart rate when combined with solriamfetol.
Caffeine; Sodium Benzoate: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Carbidopa; Levodopa: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as levodopa. Caution is recommended since this combination has not been evaluated.
Carbidopa; Levodopa; Entacapone: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as entacapone. Caution is recommended since this combination has not been evaluated. (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as levodopa. Caution is recommended since this combination has not been evaluated.
Cetirizine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Chlophedianol; Dexchlorpheniramine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Chlorpheniramine; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Chlorpheniramine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Cocaine: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as cocaine. Caution is recommended since this combination has not been evaluated. In addition, the noradrenergic effects of cocaine may increase the likelihood of an elevated blood pressure and heart rate, both of which have been associated with solriamfetol administration.
Codeine; Guaifenesin; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Codeine; Phenylephrine; Promethazine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Desloratadine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Desvenlafaxine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and antidepressants that are serotonin norepinephrine reuptake inhibitors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Dexbrompheniramine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Dexmethylphenidate: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and methylphenidate derivatives, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Dextroamphetamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and amphetamines, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Dextromethorphan; Bupropion: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as bupropion. Caution is recommended since this combination has not been evaluated.
Dextromethorphan; Diphenhydramine; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Dextromethorphan; Guaifenesin; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Dextromethorphan; Guaifenesin; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Diethylpropion: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and diethylpropion, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Diphenhydramine; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Dopamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Droxidopa: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Duloxetine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and antidepressants that are serotonin norepinephrine reuptake inhibitors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Entacapone: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as entacapone. Caution is recommended since this combination has not been evaluated.
Ephedrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Ephedrine; Guaifenesin: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Epinephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Ergotamine; Caffeine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and caffeine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Esketamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and esketamine. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Fexofenadine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Guaifenesin; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Guaifenesin; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Ibuprofen; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Isocarboxazid: (Contraindicated) The concurrent use of noradrenergic drugs, such as solriamfetol, and monoamine oxidase inhibitors (MAOIs) or use of solriamfetol within 14 days of MAOI therapy is contraindicated due to the increased risk for hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Levodopa: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as levodopa. Caution is recommended since this combination has not been evaluated.
Levomilnacipran: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and antidepressants that are serotonin norepinephrine reuptake inhibitors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Lidocaine; Epinephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Lisdexamfetamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and amphetamines, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Loratadine; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Methamphetamine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and amphetamines, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Methylphenidate Derivatives: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and methylphenidate derivatives, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Methylphenidate: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and methylphenidate derivatives, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Midodrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Milnacipran: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and antidepressants that are serotonin norepinephrine reuptake inhibitors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Modafinil: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and modafinil, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Monoamine oxidase inhibitors: (Contraindicated) The concurrent use of noradrenergic drugs, such as solriamfetol, and monoamine oxidase inhibitors (MAOIs) or use of solriamfetol within 14 days of MAOI therapy is contraindicated due to the increased risk for hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Naproxen; Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Norepinephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Phenelzine: (Contraindicated) The concurrent use of noradrenergic drugs, such as solriamfetol, and monoamine oxidase inhibitors (MAOIs) or use of solriamfetol within 14 days of MAOI therapy is contraindicated due to the increased risk for hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Phentermine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and phentermine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Phentermine; Topiramate: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and phentermine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Pramipexole: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as pramipexole. Caution is recommended since this combination has not been evaluated.
Prilocaine; Epinephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Promethazine; Phenylephrine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Pseudoephedrine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Pseudoephedrine; Triprolidine: (Moderate) Monitor blood pressure and heart rate during routine coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and pseudoephedrine, a CNS stimulant. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Rasagiline: (Contraindicated) The concurrent use of solriamfetol, a noradrenergic drugs, and rasagiline, a monoamine oxidase inhibitor, or use of solriamfetol within 14 days of rasagiline is contraindicated due to the increased risk for hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. In addition, solriamfetol is a central dopaminergic drug and concurrent use with other dopaminergic drugs, such as rasagiline, has not been studied.
Ropinirole: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as ropinirole. Caution is recommended since this combination has not been evaluated.
Rotigotine: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as rotigotine. Caution is recommended since this combination has not been evaluated.
Safinamide: (Contraindicated) The concurrent use of solriamfetol, a noradrenergic drugs, and safinamide, a monoamine oxidase inhibitor, or use of solriamfetol within 14 days of safinamide is contraindicated due to the increased risk for hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. In addition, solriamfetol is a central dopaminergic drug and concurrent use with other dopaminergic drugs, such as safinamide, has not been studied.
Selegiline: (Contraindicated) The concurrent use of noradrenergic drugs, such as solriamfetol, and monoamine oxidase inhibitors (MAOIs), such as selegiline, or use of solriamfetol within 14 days of MAOI therapy is contraindicated due to the increased risk for hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Serdexmethylphenidate; Dexmethylphenidate: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and methylphenidate derivatives, which are CNS stimulants. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Serotonin norepinephrine reuptake inhibitors: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and antidepressants that are serotonin norepinephrine reuptake inhibitors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Tolcapone: (Moderate) Monitor for dopamine-mediated effects including nausea, vomiting, dizziness, tremor, and changes in moods or behaviors if solriamfetol, a central dopamine and norepinephrine reuptake inhibitor, is administered with other dopaminergic drugs, such as tolcapone. Caution is recommended since this combination has not been evaluated.
Tranylcypromine: (Contraindicated) The concurrent use of noradrenergic drugs, such as solriamfetol, and monoamine oxidase inhibitors (MAOIs) or use of solriamfetol within 14 days of MAOI therapy is contraindicated due to the increased risk for hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Vasopressin, ADH: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Vasopressors: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and vasopressors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
Venlafaxine: (Moderate) Monitor blood pressure and heart rate during coadministration of solriamfetol, a norepinephrine and dopamine reuptake inhibitor, and antidepressants that are serotonin norepinephrine reuptake inhibitors. Concurrent use of solriamfetol and other medications that increase blood pressure and/or heart rate may increase the risk of such effects. Coadministration of solriamfetol with other drugs that increase blood pressure or heart rate has not been evaluated.
The mechanism by which solriamfetol improves wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is believed to be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor. Solriamfetol binds to the dopamine and norepinephrine transporters with low affinity and inhibits the reuptake of dopamine and norepinephrine with low potency. There is no appreciable binding affinity for the serotonin transporter and the drug does not inhibit serotonin reuptake. Solriamfetol has no appreciable binding affinity to dopamine, serotonin, norepinephrine, GABA, adenosine, histamine, orexin, benzodiazepine, muscarinic acetylcholine, or nicotinic acetylcholine receptors.
Solriamfetol is administered orally. Plasma protein binding is insignificant (less than 20%). Solriamfetol exhibits first-order elimination and is minimally metabolized. The mean elimination half-life is about 7.1 hours. Approximately 95% of a dose is excreted as unchanged solriamfetol, and 1% or less of a dose is excreted in the urine as N-acetyl solriamfetol, a minor inactive metabolite. Active tubular secretion is likely involved in the renal elimination of the parent drug. Steady-state is reached in 3 days, and once daily administration is expected to result in minimal accumulation.
Affected cytochrome P450 isoenzymes and drug transporters: None
Based on in vitro data, clinically significant pharmacokinetic drug interactions involving CYP isoenzymes or drug transporters are not expected. Solriamfetol is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6, CYP2E1, or CYP3A4. It does not induce CYP1A2, CYP2B6, CYP3A4, or UGT1A1 at clinically relevant concentrations. Solriamfetol is a low-affinity substrate of OCT2, MATE1, OCTN1, and OCTN2 and a weak inhibitor of OCT2 and MATE1. It is not an inhibitor of OCT1, MATE2-K, OCTN1, or OCTN2. Solriamfetol does not appear to be a substrate or inhibitor of P-gp, BCRP, OATP1B1, OATP1B3, OAT1, or OAT3.
-Route-Specific Pharmacokinetics
Oral Route
The oral bioavailability of solriamfetol is approximately 95%. Peak plasma concentrations occur at a median of 2 hours (range: 1.25 to 3 hours) post-dose under fasting conditions. Solriamfetol exhibits linear kinetics within the therapeutic dose range. Taking solriamfetol with a high-fat meal did not have a significant effect on overall medication concentration but did delay the time to peak plasma concentration by approximately 1 hour.
-Special Populations
Renal Impairment
The half-life of solriamfetol in patients with mild, moderate, or severe renal impairment is increased 1.2-, 1.9-, and 3.9-fold, respectively, compared to subjects with normal renal function. Exposure (AUC) and half-life of solriamfetol were significantly increased in patients with end-stage renal disease. An average of 21% of solriamfetol was removed by hemodialysis. Generally, the median time to maximum concentrations was not affected by renal impairment. Because solriamfetol is primarily eliminated renally as the parent drug, dosage adjustments are required in patients with moderate to severe renal impairment.
Pediatrics
Clinical studies of solriamfetol have not been conducted in pediatric patients. Pharmacokinetic data are not available in this population.
Geriatric
In a population pharmacokinetic analysis, no significant differences in the pharmacokinetics of solriamfetol were observed based upon age. Additionally, no clinically significant differences in safety or effectiveness were observed between elderly and younger patients. However, because solriamfetol is eliminated primarily through the kidneys as the parent compound, consider lower doses and close monitoring in populations at risk for a decline in renal function, such as the elderly.
Gender Differences
In a population pharmacokinetic analysis, no significant differences in the pharmacokinetics of solriamfetol were observed based upon gender.
Ethnic Differences
In a population pharmacokinetic analysis, no significant differences in the pharmacokinetics of solriamfetol were observed based upon ethnicity.