Belsomra

(Suvorexant)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Suvorexant is used to help people who have trouble falling asleep or staying asleep at night. It works by blocking certain brain chemicals that keep you awake.[2] Belsomra is currently approved and in use across 29 indications[4].[1]

Belsomra is one of 466 small molecule programs targeting Sleep. It is currently in Approved.

Indications

Total Trials

Active Trials

465

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

SleepRecruiting

SuicideRecruiting

Restless Legs SyndromeCompleted

Alzheimer DiseaseApproved

Parkinson DiseaseActive, not recruiting

DeliriumWithdrawn

Panic DisorderCompleted

InsomniaCompleted

Alcohol AbuseApproved

Sleep DisorderApproved

SleepPhase 2

Recruiting

SuicidePhase 2

Recruiting

Restless Legs SyndromeApproved

Completed

Alzheimer DiseaseApproved

Approved

Parkinson DiseaseApproved

Active, not recruiting

DeliriumApproved

Withdrawn

Panic DisorderApproved

Completed

InsomniaApproved

Completed

Alcohol AbuseApproved

Approved

Sleep DisorderApproved

Approved

Showing 10 of 29 indications

Competition

Competitive Landscape

165 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Belsomra

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

1 2

NOVOLIN R

Novo Nordisk

Preclinical

5 3

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 4

Aurlumyn

BBTG International Inc.

Preclinical

1 5

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

1 6

Inderal

WWyeth-Lederle Vaccines

Preclinical

1 7

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

1 8

GLP-1

RRigshospitalet, Denmark

Preclinical

2 9

Routine Treatment

GSK

Preclinical

1 10

Antiplatelet Drug

FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Alcohol Use Disorder (AUD)

NCT06679062

Phase 1Recruiting

Alcohol

NCT06326684

Q2 2027

Phase 3Recruiting

Insomnia

NCT06655883

Q3 2027

Phase 2Recruiting

Suicide

NCT06854224

Q4 2027

PreclinicalRecruiting

Nicotine Dependence

NCT05630781

Clinical

Trials by Indication[1]

Insomnia15 trials

Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia

Completed·—·Phase 4·NCT03034018·60 enrolled

Suvorexant and Trauma Related Insomnia

Completed·—·Phase 4·NCT02704754·41 enrolled

Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes

Recruiting·—·Phase 4·NCT05593653·61 enrolled

Show 12 more trials

Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00792298·254 enrolled

Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia

Unknown status·—·Phase 4·NCT03768713·34 enrolled

Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01097629·1,020 enrolled

Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01097616·1,023 enrolled

Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02750306·285 enrolled

A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01021813·781 enrolled

To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia

Completed·JJichi Medical University·Phase 4·NCT02849184·82 enrolled

Suvorexant (Belsomra) for the Treatment of Bipolar Depression With Insomnia

Withdrawn·MMassachusetts General Hospital·Phase 4·NCT03764683

Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs

Completed·HHenry Ford Health System·Phase 4·NCT03312517·12 enrolled

The Efficacy of Suvorexant in Treatment of Patients With Substance Use Disorder and Insomnia: A Pilot Open Trial

Completed·MMilton S. Hershey Medical Center·Phase 2/3·NCT03412591·28 enrolled

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants With Opioid Use Disorder

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06655883·300 enrolled

Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration

Completed·CColumbia University·Approved·NCT05823844·100 enrolled

Delirium4 trials

Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04571944·207 enrolled

Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

Withdrawn·MMayo Clinic·Phase 4·NCT06834386

Suvorexant and Sleep/Delirium in ICU Patients

Completed·—·Phase 4·NCT04092894·100 enrolled

Show 1 more trial

REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant

Completed·—·Phase 2·NCT05733286·142 enrolled

Sleep Disturbance2 trials

Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

Recruiting·VVA Office of Research and Development·Phase 4·NCT03642028·190 enrolled

Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

Completed·JJohns Hopkins University·Phase 2·NCT04287062·249 enrolled

Abuse Potential2 trials

Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT03657355·63 enrolled

A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05106153·127 enrolled

Opioid Use Disorder2 trials

Dual-Orexin Antagonism As a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder

Terminated·WWayne State University·Phase 2·NCT04262193·37 enrolled

Measuring Acute Drug Demand in Humans

Recruiting·UUniversity of Maryland, Baltimore·Phase 1·NCT05829655·75 enrolled

36 more indications

Alcohol Use Disorder2 trials

Orexin Receptor Antagonists as Modulators of Threat Sensitivity in Individuals With Alcohol Use Disorder

Completed·OOhio State University·Phase 1·NCT05656534·81 enrolled

Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking

Recruiting·OOhio State University·Phase 2·NCT07214207·250 enrolled

Restless Legs Syndrome2 trials

Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia

Completed·MMassachusetts General Hospital·Phase 4·NCT04706091·46 enrolled

Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant

Unknown status·—·Phase 2·NCT03755310·43 enrolled

Alcohol Use Disorder (AUD)2 trials

Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms

Recruiting·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Preclinical·NCT06484075·180 enrolled

A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

Recruiting·PPharmacotherapies for Alcohol and Substance Use Disorders Alliance·Phase 2·NCT06679062·76 enrolled

Nicotine Dependence2 trials

Targeting Orexin to Treat Nicotine Dependence

Completed·MMclean Hospital·Phase 1·NCT03999099·4 enrolled

Orexin's Role in The Neurobiology of Substance Use Disorder

Recruiting·NNational Institute on Drug Abuse (NIDA)·Preclinical·NCT05630781·140 enrolled

Alcohol1 trial

Suvorexant and Alcohol

Recruiting·WWilliam Stoops·Phase 1·NCT06326684·30 enrolled

PTSD1 trial

The Effects of Orexin Antagonism on Fear Extinction in PTSD

Not yet recruiting·VVA Office of Research and Development·Phase 4·NCT06788522·40,120 enrolled

Effectiveness1 trial

Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers

Completed·VVA Palo Alto Health Care System·Phase 4·NCT02491788·19 enrolled

Hepatic Insufficiency1 trial

Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01043926·16 enrolled

Fibromyalgia1 trial

Suvorexant in Insomnia Co-morbid With Fibromyalgia

Terminated·HHenry Ford Health System·Phase 4·NCT02684136·10 enrolled

Completed·WWilliam Stoops·Phase 1·NCT03937986·8 enrolled

Panic Disorder1 trial

The Role of Orexin in Human Panic Disorder

Completed·UUniversity of California, San Francisco·Phase 4·NCT02593682·3 enrolled

Type 2 Diabetes1 trial

Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

Completed·MMassachusetts General Hospital·Phase 4·NCT03818581·108 enrolled

Post-Traumatic Stress Disorder1 trial

Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder

Completed·—·Phase 4·NCT02849548·27 enrolled

Parkinson disease1 trial

A Pilot Study of Suvorexant for Insomnia in Parkinson Disease

Completed·—·Phase 4·NCT02729714·21 enrolled

Bipolar Disorder1 trial

Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Completed·SStanford University·Phase 4·NCT02527564·61 enrolled

Obstructive Sleep Apnea1 trial

Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01300455·26 enrolled

Sleep Quality1 trial

Sleep Quality and Amyloid-Beta Kinetics

Completed·WWashington University School of Medicine·N/A·NCT03077620·48 enrolled

Multiple Sclerosis1 trial

A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia

Completed·—·Phase 4·NCT03110315·36 enrolled

Impaired Renal Function1 trial

Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01059851·16 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01293006·25 enrolled

Opioid1 trial

Suvorexant for Opioid/Stimulant Co-use

Completed·JJohns Hopkins University·Phase 2·NCT05546515·20 enrolled

Suicide1 trial

Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial

Recruiting·MMarianne Goodman·Phase 2·NCT06854224·30 enrolled

Methamphetamine Use Disorder1 trial

The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder

Terminated·TThe University of Texas Health Science Center, Houston·Phase 2·NCT05711862·7 enrolled

Alcohol Dependence1 trial

Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

Terminated·TThe Florey Institute of Neuroscience and Mental Health·Phase 2·NCT03897062·22 enrolled

Alcoholism1 trial

Medication Development in Alcoholism: Suvorexant Versus Placebo

Completed·TThe Scripps Research Institute·Phase 2·NCT04229095·26 enrolled

Double-blind1 trial

A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study

Active, not recruiting·WWalter Reed Army Institute of Research (WRAIR)·Phase 1·NCT04273776·90 enrolled

Autism1 trial

Trial of Suvorexant for Sleep in Children With Autism

Recruiting·SStanford University·Phase 2·NCT05546554·26 enrolled

Progressive Supranuclear Palsy(PSP)1 trial

Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)

Completed·UUniversity of California, San Francisco·Approved·NCT04014387·40 enrolled

Breast Cancer1 trial

Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors

Terminated·MMedical University of South Carolina·Approved·NCT06162663·6 enrolled

Suvorexant1 trial

Suvorexant as an Adjunct to Buprenorphine Induction and Maintenance in Persons Who Use Fentanyl

Completed·JJohns Hopkins University·Phase 2·NCT05145764·76 enrolled

Sleep1 trial

Sleep Trial to Prevent Alzheimer's Disease

Recruiting·WWashington University School of Medicine·Phase 2·NCT04629547·120 enrolled

PTSD - Post Traumatic Stress Disorder1 trial

Suvorexant: Targeting Orexin to Augment Exposure Therapy in Veterans With PTSD and Insomnia

Not yet recruiting·NNorthern California Institute of Research and Education·Approved·NCT07686731·142 enrolled

Cue-reactivity1 trial

Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder

Completed·MMassachusetts General Hospital·Approved·NCT06584942·20 enrolled

Unspecified1 trial

Suvorexant to Reduce Symptoms of Nicotine Use

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT04234997·14 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 13, 2014

BELSOMRA

NDA NDA204569

Aug 13, 2014

BELSOMRA

NDA NDA204569

Apr 30, 2015

BELSOMRA

NDA NDA204569

May 3, 2016

BELSOMRA

NDA NDA204569

May 27, 2016

BELSOMRA

NDA NDA204569

Jul 12, 2018

BELSOMRA

NDA NDA204569

Jan 29, 2020

BELSOMRA

NDA NDA204569

Mar 18, 2020

BELSOMRA

NDA NDA204569

Mar 25, 2021

BELSOMRA

NDA NDA204569

Mar 10, 2025

BELSOMRA

NDA NDA204569

Sources

References

[1]
ClinicalTrials.gov — 65 trial records for Suvorexant. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Belsomra drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Suvorexant compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Suvorexant. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204569). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Belsomra. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Orexin Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[6]

Patent Cliff

Nov 20, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7951797Nov 20, 2029

12599610May 28, 2033

11980623May 29, 2033

10098892May 29, 2033

Belsomra

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Insomnia15 trials

Delirium4 trials

Sleep Disturbance2 trials

Abuse Potential2 trials

Opioid Use Disorder2 trials

Alcohol Use Disorder2 trials

Restless Legs Syndrome2 trials

Alcohol Use Disorder (AUD)2 trials

Nicotine Dependence2 trials

Alcohol1 trial

PTSD1 trial

Effectiveness1 trial

Hepatic Insufficiency1 trial

Fibromyalgia1 trial

Major Depressive Disorder1 trial

Stress1 trial

AIN1 trial

Panic Disorder1 trial

Type 2 Diabetes1 trial

Post-Traumatic Stress Disorder1 trial

Parkinson disease1 trial

Bipolar Disorder1 trial

Obstructive Sleep Apnea1 trial

Sleep Quality1 trial

Multiple Sclerosis1 trial

Impaired Renal Function1 trial

Chronic Obstructive Pulmonary Disease1 trial

Opioid1 trial

Suicide1 trial

Methamphetamine Use Disorder1 trial

Alcohol Dependence1 trial

Alcoholism1 trial

Double-blind1 trial

Autism1 trial

Progressive Supranuclear Palsy(PSP)1 trial

Breast Cancer1 trial

Suvorexant1 trial

Sleep1 trial

PTSD - Post Traumatic Stress Disorder1 trial

Cue-reactivity1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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