NDAORALTABLET
Approved
Jan 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
QUVIVIQ (daridorexant) by Idorsia is orexin receptor antagonists [moa]. Approved for orexin receptor antagonist [epc]. First approved in 2022.
Drug data last refreshed 14h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QUVIVIQ (daridorexant) is an oral orexin receptor antagonist approved in January 2022 for insomnia. It works by blocking orexin signaling in the brain, reducing wakefulness and promoting sleep onset and maintenance. The drug represents Idorsia's first major commercial product in the U.S. sleep market.
$16MPart D
PeakGrowing
8.1 years to LOEProduct is in peak commercial phase post-approval with moderate spending; field teams likely expanding and medical affairs building clinical evidence.
Mechanism 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
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Started Sep 2026
344 enrolled
Insomia 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
3 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.