Sunosi FDA Approval History
Last updated by Judith Stewart, BPharm on March 31, 2019.
FDA Approved: Yes (First approved March 20, 2019)
Brand name: Sunosi
Generic name: solriamfetol
Dosage form: Tablets
Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome
Sunosi (solriamfetol) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).
- Sunosi tablets are taken once daily upon awakening.
- Because of the potential of Sunosi to interfere with scheduled sleep, doses should not be taken within 9 hours of planned bedtime .
- Sunosi is a federally controlled substance because it has the potential to be abused. Sunosi tablets should always be stored in a secure place.
- Common side effects include headache, nausea, decreased appetite, insomnia, and anxiety.
Development timeline for Sunosi
Further information
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