NDAORALTABLET
Approved
Aug 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
BELSOMRA (suvorexant) by Merck & Co. is orexin receptor antagonists [moa]. Approved for orexin receptor antagonist [epc]. First approved in 2014.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BELSOMRA (suvorexant) is an oral tablet approved by the FDA in August 2014 as the first orexin receptor antagonist for the treatment of insomnia. It works by blocking orexin receptors in the central nervous system, thereby reducing wakefulness and promoting sleep onset and maintenance. BELSOMRA represents a mechanistically novel approach to insomnia treatment, differentiated from traditional sedative-hypnotics by its targeted action on the orexinergic arousal system.
$0.2BPart D
7.1 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)
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
Started Oct 2025
300 enrolled
Insomnia
Suvorexant for Treatment of AUD and PTSD
Started Jul 2025
76 enrolled
Alcohol Use Disorder (AUD)Post Traumatic Stress Disorder (PTSD)Insomnia
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors
Started Sep 2024
5 enrolled
Breast CancerInsomnia
REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant
Started Jun 2023
142 enrolled
Delirium in Old Age
Efficacy of Suvorexant on Post-operative Sleep Disturbance
Started May 2023
92 enrolled
Postoperative InsomniaPostoperative Delirium
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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.