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
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