Solriamfetol hydrochloride
Established medicineAlso known as Sunosi, solriamfetol (as hydrochloride), solriamfetol HCl.
Recent clinical, regulatory, research and industry developments relating to this drug.
Generic approval: SOLRIAMFETOL HYDROCHLORIDE (ANDA218016)
Generic approval: SOLRIAMFETOL HYDROCHLORIDE (ANDA218722)
Marketing authorisation: Sunosi (EMA)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy). Sunosi is indicated to improve… Show full indicationShow less
Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy). Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
- RxNorm (U.S. National Library of Medicine) — drug identity
- Regulatory event sources are credited in the Regulatory Timeline above.