Suvorexant

Generic Name: Suvorexant

Brand Names: Belsomra

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₃ClN_₆O_₂

CAS Number: 1030377-33-3

Unique Ingredient Identifier: 081L192FO9

Background: Suvorexant is a selective dual antagonist of orexin receptors OX1R and OX2R that promotes sleep by reducing wakefulness and arousal. It has been approved for the treatment of insomnia.

Indication: Suvorexant is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Associated Conditions: Insomnia

Clinical Trials

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

Phase 4

Completed

Conditions: Restless Legs Syndrome
Insomnia
Sleep Disorder

Interventions: Drug: Suvorexant
Other: Placebo

First Posted Date: 2021-01-12

Last Posted Date: 2024-01-16

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 46

Registration Number: NCT04706091

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Sleep Trial to Prevent Alzheimer's Disease

Phase 2

Recruiting

Conditions: Sleep
Alzheimer Disease

Interventions: Drug: Placebo
Drug: Suvorexant 20 mg

First Posted Date: 2020-11-16

Last Posted Date: 2025-01-15

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 200

Registration Number: NCT04629547

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

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

Phase 3

Completed

Conditions: Delirium

Interventions: Drug: Placebo
Drug: Suvorexant

First Posted Date: 2020-10-01

Last Posted Date: 2024-11-25

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 207

Registration Number: NCT04571944

Locations: 🇯🇵
Kanazawa Medical University Hospital ( Site 8514), Kahoku-gun, Ishikawa, Japan
🇯🇵
Nippon Medical School Musashi Kosugi Hospital ( Site 8502), Kawasaki, Kanagawa, Japan
🇯🇵
Tonan Hospital ( Site 8512), Sapporo, Hokkaido, Japan

and more 47 locations

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

Phase 2

Recruiting

Conditions: Sleep Disturbance
Opioid-use Disorder

Interventions: Drug: Placebos
Drug: Suvorexant

First Posted Date: 2020-02-27

Last Posted Date: 2024-08-27

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 200

Registration Number: NCT04287062

Locations: 🇺🇸
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States
🇺🇸
Ashley Addiction Treatment, Elkton, Maryland, United States
🇺🇸
Man Alive Inc., Lane Treatment Center, Baltimore, Maryland, United States

and more 1 locations

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

Early Phase 1

Active, not recruiting

Conditions: Performance Enhancing Product Use

Interventions: Drug: Suvorexant 10 mg
Drug: Zolpidem
Drug: Placebos

First Posted Date: 2020-02-18

Last Posted Date: 2025-04-03

Lead Sponsor: Walter Reed Army Institute of Research (WRAIR)

Target Recruit Count: 90

Registration Number: NCT04273776

Locations: 🇺🇸
Walter Reed Army Institute of Research, Silver Spring, Maryland, United States

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

Phase 2

Active, not recruiting

Conditions: Opioid-use Disorder
Sleep

Interventions: Drug: Suvorexant Placebo
Drug: Suvorexant

First Posted Date: 2020-02-10

Last Posted Date: 2024-08-29

Lead Sponsor: Wayne State University

Target Recruit Count: 120

Registration Number: NCT04262193

Locations: 🇺🇸
Wayne State University, Detroit, Michigan, United States

Suvorexant to Reduce Symptoms of Nicotine Use

Phase 2

Completed

Conditions: Smoking Cessation

Interventions: Drug: Suvorexant 20 mg
Drug: Suvorexant 0mg

First Posted Date: 2020-01-21

Last Posted Date: 2025-02-04

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 14

Registration Number: NCT04234997

Locations: 🇺🇸
The University of Texas Health Science Center at Houston, Houston, Texas, United States

Medication Development in Alcoholism: Suvorexant Versus Placebo

Phase 2

Completed

Conditions: Alcohol Use Disorder (AUD)

Interventions: Drug: Suvorexant 20 mg
Drug: Placebo oral tablet

First Posted Date: 2020-01-14

Last Posted Date: 2023-04-26

Lead Sponsor: The Scripps Research Institute

Target Recruit Count: 26

Registration Number: NCT04229095

Locations: 🇺🇸
Scripps Research, La Jolla, California, United States

Suvorexant and Sleep/Delirium in ICU Patients

Phase 4

Recruiting

Conditions: Insomnia
Sleep Fragmentation
Postoperative Delirium
Sleep Initiation and Maintenance Disorders

Interventions: Drug: Suvorexant 20 mg
Drug: Placebo oral tablet

First Posted Date: 2019-09-17

Last Posted Date: 2023-11-18

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 120

Registration Number: NCT04092894

Locations: 🇺🇸
Montefiore Medical Center/Albert Einstein college of Medicine, Bronx, New York, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)

Phase 4

Recruiting

Conditions: Treatment

Interventions: Drug: Suvorexant
Drug: Placebo oral capsule
Drug: Zolpidem

First Posted Date: 2019-07-10

Last Posted Date: 2023-10-27

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 60

Registration Number: NCT04014387

Locations: 🇺🇸
University of California- San Francisco, San Francisco, California, United States

Drug Development Updates

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