Solriamfetol

The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).

• SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies ( 14 )] . Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA.ICD-10: G47.419

• SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of monoamine oxidase inhibitor, because of the risk of hypertensive reaction [see Drug Interactions ( 7.1 )] . Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days.contraindicated

Administer once daily upon awakening. Avoid administration within 9 hours of planned bedtime because of the potential to interfere with sleep. ( 2.2 ) Starting dose for patients with narcolepsy: 75 mg once daily. ( 2.3 ) Starting dose for patients with OSA: 37.5 mg once daily. ( 2.4 ) Dose may be increased at intervals of at least 3 days. ( 2.3 , 2.4 ) Maximum dose is 150 mg once daily. ( 2.3 , 2.4 ) Renal impairment ( 2.5 , 8.6 , 12.3 ): Moderate impairment: Starting dose is 37.5 mg once daily. May increase to 75 mg once daily after at least 7 days. Severe impairment: Starting dose and maximum dose is 37.5 mg once daily. End stage renal disease (ESRD): Not recommended. 2.1 Important Considerations Prior to Initiating Treatment Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled [see Warnings and Precautions ( 5.1 )] . 2.2 General Administration Instructions Administer SUNOSI orally upon awakening with or without food. Avoid taking SUNOSI within 9 hours of planned bedtime because of the potential to interfere with sleep if taken too late in the day. SUNOSI 75 mg tablets are functionally scored tablets that can be split in half (37.5 mg) at the score line. 2.3 Dosage in Narcolepsy Initiate SUNOSI at 75 mg once daily in adults with narcolepsy. The recommended dose range for SUNOSI is 75 mg to 150 mg once daily. Based on efficacy and tolerability, the dosage of SUNOSI may be doubled at intervals of at least 3 days. The maximum recommended dose is 150 mg once daily.

Blood Pressure and Heart Rate Increases : Measure heart rate and blood pressure prior to initiating and periodically throughout treatment. Control hypertension before and during therapy. Avoid use in patients with unstable cardiovascular disease, serious heart arrhythmias, or other serious heart problems. ( 5.1 ) Psychiatric Symptoms : Use caution in treating patients with a history of psychosis or bipolar disorders. Consider dose reduction or discontinuation of SUNOSI if psychiatric symptoms develop. ( 5.2 ) 5.1 Blood Pressure and Heart Rate Increases SUNOSI increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion [see Adverse Reactions ( 6.1 )] . Epidemiological data show that chronic elevations in blood pressure increase the risk of major adverse cardiovascular events (MACE), including stroke, heart attack, and cardiovascular death. The magnitude of the increase in absolute risk is dependent on the increase in blood pressure and the underlying risk of MACE in the population being treated. Many patients with narcolepsy and OSA have multiple risk factors for MACE, including hypertension, diabetes, hyperlipidemia, and high body mass index (BMI). Assess blood pressure and control hypertension before initiating treatment with SUNOSI. Monitor blood pressure regularly during treatment and treat new-onset hypertension and exacerbations of pre-existing hypertension.

The following adverse reactions are discussed in greater detail in other sections of the label: Blood Pressure and Heart Rate Increases [see Warnings and Precautions ( 5.1 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥ 5% and greater than placebo): headache, nausea, decreased appetite, insomnia, and anxiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics, Inc. at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SUNOSI has been evaluated in 930 patients (ages 18 to 75 years) with narcolepsy or OSA. Among these patients, 396 were treated with SUNOSI in the 12-week placebo-controlled trials at doses of 37.5 mg (OSA only), 75 mg, and 150 mg once daily. Information provided below is based on the pooled 12-week placebo-controlled studies in patients with narcolepsy or OSA. Most Common Adverse Reactions The most common adverse reactions (incidence ≥ 5% and greater than placebo) reported more frequently with the use of SUNOSI than placebo in either the narcolepsy or OSA populations were headache, nausea, decreased appetite, anxiety, and insomnia.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SUNOSI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220 or contacting the company at www.SunosiPregnancyRegistry.com . Risk Summary Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of solriamfetol during organogenesis caused maternal and fetal toxicities in rats and rabbits at doses ≥ 4 and 5 times and was teratogenic at doses 19 and ≥ 5 times, respectively, the maximum recommended human dose (MRHD) of 150 mg based on mg/m 2 body surface area. Oral administration of solriamfetol to pregnant rats during pregnancy and lactation at doses ≥ 7 times the MRHD based on mg/m 2 body surface area resulted in maternal toxicity and adverse effects on fertility, growth, and development in offspring (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Solriamfetol exhibits linear kinetics over the dose range of 42 to 1008 mg (approximately 0.28 to 6.7 times the maximum recommended dosage). Steady state is reached in 3 days, and once‑daily administration is expected to result in minimal accumulation (1.06 times single‑dose exposure).

A specific reversal agent for SUNOSI is not available. Hemodialysis removed approximately 21% of a 75 mg dose in end stage renal disease patients. Overdoses should be managed with primarily supportive care, including cardiovascular monitoring. Consult with a Certified Poison Control Center at 1-800-222-1222 for latest recommendations.

• Mar 20, 2019NDANDA211230Axsome Malta

1. 1Drug Ineffective53214%
2. 2Anxiety3258.8%
3. 3Headache3068.3%
4. 4Nausea2927.9%
5. 5Product Administration Interrupted2647.1%
6. 6Fatigue2627.1%
7. 7Off Label Use2476.7%
8. 8Somnolence2346.3%
9. 9Product Dose Omission Issue1895.1%
10. 10Surgery1674.5%
11. 11Depression1634.4%
12. 12Dizziness1624.4%
13. 13Insomnia1554.2%
14. 14Feeling Abnormal1484.0%
15. 15Blood Pressure Increased1333.6%

The 10 most recently updated of 30 ClinicalTrials.gov registrations naming Solriamfetol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• WAKIX® (Pitolisant) Pregnancy Registry
  Recruiting · Observational · 1,329 enrolled · Harmony Biosciences Management, Inc.
  NCT05536011updated 2026-06-12
• Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
  Recruiting · Phase 2 · Interventional · 46 enrolled · Johns Hopkins University
  NCT06170970updated 2026-06-09
• RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
  Completed · Phase 2 · Interventional · 361 enrolled · Duke University
  NCT06404099updated 2026-06-03
• Solriamfetol and CBT-I in Patients With Insomnia Disorder
  Completed · Phase 4 · Interventional · 115 enrolled · University of Pennsylvania
  NCT05838430updated 2026-05-12
• Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
  Recruiting · Phase 3 · Interventional · 508 enrolled · Axsome Therapeutics, Inc.
  NCT07484217updated 2026-03-20
• A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
  Completed · Phase 3 · Interventional · 516 enrolled · Axsome Therapeutics, Inc.
  NCT05972044updated 2026-02-10
• Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
  Completed · Phase 4 · Interventional · 59 enrolled · Axsome Therapeutics, Inc.
  NCT04789174updated 2026-01-26
• RECOVER-SLEEP: Platform Protocol
  Completed · Phase 2 · Interventional · 830 enrolled · Duke University
  NCT06404086updated 2026-01-22
• Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
  Completed · Phase 3 · Interventional · 346 enrolled · Axsome Therapeutics, Inc.
  NCT06360419updated 2026-01-05
• Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder
  Enrolling by invitation · Phase 3 · Interventional · 300 enrolled · Axsome Therapeutics, Inc.
  NCT06878976updated 2025-11-25

Frequently asked questions

How does Solriamfetol work?

The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).

What is Solriamfetol used for?

According to FDA labeling, Solriamfetol carries indications including: SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies ( 14 )] . Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Solriamfetol?

Solriamfetol is classified as Centrally acting sympathomimetics, Dopamine and Norepinephrine Reuptake Inhibitor, Dopamine Uptake Inhibitors, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Increased Dopamine Activity, Increased Norepinephrine Activity.

What are the brand names for Solriamfetol?

Solriamfetol is marketed under brand names including Sunosi.

What are the contraindications for Solriamfetol?

Solriamfetol labeling lists contraindications including: SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of monoamine oxidase inhibitor, because of the risk of hypertensive reaction [see Drug Interactions ( 7.1 )] . Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days.. Always consult the full prescribing information and a clinician.