Section 10 · Monograph

Solriamfetol

Reviewed Nov 2026FDA label

SunosiDopamine/NE reuptake inhibitor

Indications

To improve wakefulness in adult patients with excessive daytime sleepiness (EDS) associated with narcolepsy.FDA-labeled
To improve wakefulness in adult patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA). Limitation of use: not a treatment for the underlying airway obstruction; patients should have OSA-directed therapy optimized for at least 1 month prior to initiation, and continued during solriamfetol treatment.FDA-labeled

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI); exact mechanism by which it promotes wakefulness is unknown.
Increases extracellular dopamine and norepinephrine concentrations by inhibiting their reuptake transporters (DAT and NET).
Structurally related to phenylalanine, pharmacologically distinct from amphetamine-class stimulants and modafinil/armodafinil.
Classified as a Schedule IV controlled substance based on abuse-liability data showing some euphoric/reinforcing effects at supratherapeutic doses.

Narcolepsy: initiate at 75 mg once daily; may double the dose at intervals of at least 3 days, up to a maximum of 150 mg once daily.
OSA: initiate at 37.5 mg once daily; may double the dose at intervals of at least 3 days, up to a maximum of 150 mg once daily.
Administer upon awakening; avoid dosing within 9 hours of planned bedtime.

Moderate renal impairment (eGFR 30 to <60): starting dose 37.5 mg once daily; max dose 75 mg once daily after at least 7 days.
Severe renal impairment (eGFR 15 to <30): 37.5 mg once daily; do not exceed this dose.
End-stage renal disease (eGFR <15): use is not recommended.

Concomitant use with, or within 14 days of discontinuing, monoamine oxidase inhibitors (MAOIs) — risk of hypertensive reaction.

MAO inhibitors: contraindicated — do not use concomitantly or within 14 days of MAOI discontinuation.
Dopaminergic drugs: use with caution; theoretical additive dopaminergic effects.
Drugs that increase blood pressure or heart rate: use with caution due to solriamfetol's own dose-dependent increases in BP/HR.
Other stimulants/wake-promoting agents: avoid combination given overlapping mechanisms/toxicity; generally should not be combined with modafinil/armodafinil or amphetamine-type stimulants.

Most common (≥5% and more than placebo): headache, nausea, decreased appetite, insomnia, anxiety.
Increases in systolic and diastolic blood pressure and heart rate in a dose-dependent manner — assess and manage pre-existing hypertension before initiating.
Psychiatric symptoms: anxiety, irritability, insomnia; use caution with history of psychosis or bipolar disorder.
Decreased appetite and modest weight loss reported.
Rare: potential for misuse/abuse given stimulant-like properties (Schedule IV).

Blood pressure and heart rate at baseline and periodically, particularly after dose increases.
Assess and optimize control of hypertension/cardiovascular disease prior to and during treatment.
Monitor for new-onset or worsening anxiety, agitation, irritability, or psychiatric symptoms.
Renal function assessment prior to and during treatment.
Appetite/weight periodically, especially in patients with low baseline BMI.
Assess for signs of misuse given controlled-substance status.

Pregnancy: Available human data are insufficient to establish drug-associated risk of major birth defects or miscarriage. Animal studies showed developmental toxicity at higher exposures. A pregnancy exposure registry monitors outcomes.
Lactation: No information on presence in human milk, effects on the breastfed infant, or on milk production. Monitor breastfed infants for agitation, insomnia, poor feeding/anorexia, and inadequate weight gain.