SUNOSI

Dopamine Norepinephrine Reuptake Inhibitor Narcolepsy Agents

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.

constipation / Delayed / 3.0-3.0
palpitations / Early / 2.0-3.0
teeth grinding (bruxism) / Delayed / Incidence not known
hypertension / Early / Incidence not known
dyspnea / Early / Incidence not known
chest pain (unspecified) / Early / Incidence not known

headache / Early / 7.0-16.0
nausea / Early / 5.0-8.0
anxiety / Delayed / 2.0-7.0
insomnia / Early / 5.0-5.0
diarrhea / Early / 4.0-5.0
xerostomia / Early / 2.0-4.0
irritability / Delayed / 3.0-3.0
abdominal pain / Early / 3.0-3.0
dizziness / Early / 2.0-2.0
hyperhidrosis / Delayed / 2.0-2.0
tremor / Early / Incidence not known
agitation / Early / Incidence not known
restlessness / Early / Incidence not known
vomiting / Early / Incidence not known
weight loss / Delayed / Incidence not known
cough / Delayed / Incidence not known
rash / Early / Incidence not known
urticaria / Rapid / Incidence not known

SUNOSI

Rx, schedule IV

Dopamine and norepinephrine reuptake inhibitor
Used 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

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.[64026]

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.[64026]

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

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.

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; Dihydrocodeine; 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; 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.
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.
Hydrocodone; 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.
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.
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.

SUNOSI Oral Tab: 75mg, 150mg

150 mg/day PO.

150 mg/day PO.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

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.[64026]

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.[64026]
 
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.[64026]

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.

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.[64026]