Sunosi (solriamfetol)
- Region
- 🇪🇺 EU
- Active substance
- solriamfetol
- Company
- Atnahs Pharma Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Narcolepsy; Sleep Apnea, Obstructive
- CHMP opinion
- Thu 14 Nov 2019
- EU approval
- Thu 16 Jan 2020
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004893
- ATC
- N06BA14
- Official record
- www.ema.europa.eu
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 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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.