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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

DateArticle
Mar 20, 2019Approval FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Dec 21, 2018Jazz Pharmaceuticals Receives New PDUFA Goal Date for Solriamfetol for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Mar  2, 2018Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Dec 21, 2017Jazz Pharmaceuticals Submits New Drug Application for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnea

See also

Sunosi (solriamfetol) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer