BELSOMRA (suvorexant)
BELSOMRA is indicated for the treatment of Insomnia.
How BELSOMRA Works
Suvorexant is an orexin receptor antagonist. It works by blocking the binding of wake-promoting neuropeptides, orexin A and orexin B, to the OX1R and OX2R receptors in the brain. By antagonizing this system, the medication suppresses the physiological wake drive to facilitate sleep.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-08-13
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- TABLET
BELSOMRA Approval History
What BELSOMRA Treats
1 indicationsBELSOMRA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
BELSOMRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BELSOMRA
3 of 17FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
37 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06484075 | 10001561 001561-AA | Ph 1, Ph 2 | recruiting | Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms |
| NCT05593653 results posted | 2022P000768 | Ph 4 | completed | Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia |
| NCT06788522 | MHBP-006-24S | Ph 4 | not yet recruiting | The Effects of Orexin Antagonism on Fear Extinction in PTSD |
| NCT06655883 | 4305-098 MK-4305-098 | Ph 3 | recruiting | A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) |
| NCT05546554 | IRB-67222 1P50HD109861 | Ph 2 | recruiting | Trial of Suvorexant for Sleep in Children With Autism |
| NCT06584942 | 2024P002380 | Ph 4 | recruiting | Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study) |
| NCT04287062 | IRB00223942 U01HL150835 | Ph 2 | completed | Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder |
| NCT04014387 | 20181608 | Ph 4 | completed | Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP) |
| NCT05145764 | IRB00301337 UH3DA048734 | Ph 2 | recruiting | Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl |
| NCT06679062 SUV | AS210006-A10 | Ph 2 | recruiting | Suvorexant for Treatment of AUD and PTSD |
| NCT03642028 | MHBB-009-17F 1I01CX001814-01 | Ph 4 | recruiting | Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress |
| NCT06834386 | 24-005893 NCI-2025-00771, 24-005893 | Ph 4 | withdrawn | Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients |
| NCT05106153 | CR109099 42847922MDD1017 | Ph 1 | completed | A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem |
| NCT03110315 DREAM results posted | TRB 2017.2 | Ph 4 | completed | A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia |
| NCT04571944 results posted | 4305-085 MK-4305-085, jRCT2031200149 | Ph 3 | completed | Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085) |
| NCT04262193 | DORA, Sleep and Opioid Use | Ph 2 | terminated | Dual-Orexin Antagonism As a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder |
| NCT03818581 results posted | 2019P000076 | Ph 4 | completed | Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes |
| NCT02729714 results posted | DJB-2015-01 | Ph 4 | completed | A Pilot Study of Suvorexant for Insomnia in Parkinson Disease |
| NCT05823844 | AAAU4343 | Ph 4 | recruiting | Efficacy of Suvorexant on Post-operative Sleep Disturbance |
| NCT04706091 results posted | 2020P003535 | Ph 4 | completed | Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia |
| NCT02849548 results posted | GHUCCTS2016-0377 1K01MH110647-01A1 | Ph 4 | completed | Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder |
| NCT02704754 results posted | GHUCCTS2015-1333 | Ph 4 | completed | Suvorexant and Trauma Related Insomnia |
| NCT02527564 results posted | 53208 | Ph 4 | completed | Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder |
| NCT03034018 results posted | 2016P002667 | Ph 4 | completed | Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia |
| NCT02593682 results posted | 2015078 | Ph 4 | completed | The Role of Orexin in Human Panic Disorder |
| NCT02684136 results posted | FM16 | Ph 4 | terminated | Suvorexant in Insomnia Co-morbid With Fibromyalgia |
| NCT02491788 results posted | IRB-34778 | Ph 4 | completed | Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers |
| NCT02785406 results posted | HSC-MS-16-0120 | Ph 2 | completed | Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use |
| NCT02750306 results posted | 4305-061 2015-003154-40, MK-4305-061 | Ph 3 | completed | Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061) |
| NCT03657355 | ID-078-107 | Ph 1 | completed | Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users |
| NCT02849184 Super1 results posted | 4305-063 | Ph 4 | completed | To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia |
| NCT01059851 results posted | 4305-023 2010_505 | Ph 1 | completed | Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED) |
| NCT00792298 results posted | 4305-006 2008_583 | Ph 2 | completed | Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006) |
| NCT01300455 results posted | 4305-036 | Ph 1 | completed | Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036) |
| NCT01043926 results posted | 4305-017 2010_500 | Ph 1 | completed | Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017) |
| NCT01021813 results posted | 4305-009 2009_696 | Ph 3 | completed | A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3) |
| NCT01293006 results posted | 4305-032 | Ph 1 | completed | Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BELSOMRA FDA Label Details
Indications & Usage
FDA Label (PDF)BELSOMRA is indicated for the treatment of Insomnia.
Pro Intelligence Preview
Deep insights for BELSOMRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 48 active patents
Trial Analysis
- • 37 total trials
- • Stage: Mature
Competitive Landscape
- • 17 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment