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 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BELSOMRA (suvorexant) is an oral orexin receptor antagonist approved in 2014 for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. It works by blocking orexin neurotransmitters in the brain that promote wakefulness, thereby facilitating sleep initiation and consolidation.
$0.161BPart D
PeakStable
6.9 years to LOEBELSOMRA remains at peak commercial maturity with $161M in Part D spending, supporting a stable-sized commercial and medical affairs team focused on market defense.
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)
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.