NDAORALTABLET
Approved
Jan 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
QUVIVIQ (daridorexant) by Idorsia is orexin receptor antagonists [moa]. Approved for orexin receptor antagonist [epc]. First approved in 2022.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QUVIVIQ (daridorexant) is an oral tablet orexin receptor antagonist approved by the FDA on January 7, 2022, developed by Idorsia for the treatment of insomnia. It works by blocking orexin receptors in the brain, which promotes sleep by reducing wakefulness-promoting signals. QUVIVIQ represents a newer generation within the orexin antagonist class, offering an alternative mechanism to traditional sedative-hypnotics.
$0.0BPart D
8.6 years to LOEMechanism of Action
Orexin Receptor Antagonists
Pharmacologic Class:
Orexin Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Daridorexant for Alcohol Use Disorder
Started Jan 2027
150 enrolled
Alcohol Use Disorder
Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia
Started Apr 2026
134 enrolled
InsomniaMajor Depressive Disorder
A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder
Started Dec 2024
164 enrolled
Insomnia Disorder
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
Started Nov 2024
785 enrolled
Insomnia
Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada
Started Jun 2024
100 enrolled
Insomnia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.