NDAORALTABLET
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
Data completeness
7/8 — Comprehensive
SUNOSI (solriamfetol) by Axsome Therapeutics is dopamine uptake inhibitors [moa]. Approved for narcolepsy, obstructive sleep apnea. First approved in 2019.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUNOSI (solriamfetol) is an oral tablet approved by the FDA on March 20, 2019, for the treatment of excessive daytime sleepiness. It functions as a dopamine and norepinephrine reuptake inhibitor, working through dual inhibition of monoamine reuptake mechanisms. The product represents a novel mechanism of action in the wakefulness-promoting agent category and is currently in its peak lifecycle stage.
$0.0BPart D
16.7 years to LOEMechanism of Action
Dopamine Uptake Inhibitors
Pharmacologic Class:
Dopamine and Norepinephrine Reuptake Inhibitor
Indications (2)
Clinical Trials (13)
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Started Feb 2026
508 enrolled
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder
Started Feb 2025
300 enrolled
Binge-Eating Disorder
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Started Aug 2024
520 enrolled
Excessive SleepinessShift-work Disorder
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Started Jun 2024
46 enrolled
Multiple SclerosisMultiple Sclerosis Fatigue
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
Started Apr 2024
450 enrolled
Binge-Eating Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.