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Quviviq FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 12, 2022.

FDA Approved: Yes (First approved January 7, 2022)
Brand name: Quviviq
Generic name: daridorexant
Dosage form: Tablets
Company: Idorsia Ltd.
Treatment for: Insomnia

Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) for the treatment of insomnia.

  • Quviviq is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
  • FDA approval of Quviviq was based on the results from two Phase 3 clinical studies that demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, as well as patient reported total sleep time.
  • Quviviq tablets are administered once per night, taken orally within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening.
  • Quviviq may cause serious adverse reactions including CNS-depressant effects and daytime impairment; worsening of depression/suicidal ideation; sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms; complex sleep behaviors including sleepwalking, sleepdriving, and engaging in other activities while not fully awake; and compromised respiratory function.
  • Common adverse reactions include headache, somnolence and fatigue.

Development timeline for Quviviq

Jan 10, 2022Approval FDA Approves Quviviq (daridorexant) for the Treatment of Adults with Insomnia
Mar 10, 2021FDA Accepts the New Drug Application for Review of Idorsia’s Daridorexant for the Treatment of Adult Patients with Insomnia
Jul  6, 2020Idorsia Announces Positive Results in the Second Phase 3 Study of Daridorexant

Further information

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