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

Targeting Orexin to Treat Nicotine Dependence

Phase 1

Recruiting

Conditions: Nicotine Dependence

Interventions: Drug: Placebo oral tablet
Drug: Suvorexant 10 mg
Drug: Suvorexant 20 mg

First Posted Date: 2019-06-26

Last Posted Date: 2024-01-05

Lead Sponsor: Mclean Hospital

Target Recruit Count: 45

Registration Number: NCT03999099

Locations: 🇺🇸
McLean Hospital, Belmont, Massachusetts, United States

Suvorexant and Cocaine

Early Phase 1

Completed

Conditions: Cocaine Use Disorder

Interventions: Drug: Cocaine
Drug: Suvorexant
Drug: Placebo oral capsule

First Posted Date: 2019-05-06

Last Posted Date: 2023-02-09

Lead Sponsor: William Stoops

Target Recruit Count: 8

Registration Number: NCT03937986

Locations: 🇺🇸
University of Kentucky, Lexington, Kentucky, United States

Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

Phase 2

Terminated

Conditions: Insomnia
Alcohol Use Disorder

Interventions: Other: placebo
Drug: Suvorexant 20 mg

First Posted Date: 2019-04-01

Last Posted Date: 2023-02-15

Lead Sponsor: The Florey Institute of Neuroscience and Mental Health

Target Recruit Count: 22

Registration Number: NCT03897062

Locations: 🇦🇺
St Vincent's Hospital, Melbourne, Victoria, Australia

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

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus
Insomnia
Sleep Disorder
Inflammation

Interventions: Drug: Suvorexant
Other: Placebo

First Posted Date: 2019-01-28

Last Posted Date: 2024-08-20

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 108

Registration Number: NCT03818581

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

Medical Management of Sleep Disturbance During Opioid Tapering

Phase 2

Completed

Conditions: Sleep Disturbance
Opioid Withdrawal
Opioid Dependence

Interventions: Drug: Placebo oral capsule
Drug: High Dose Suvorexant
Drug: Low Dose Suvorexant

First Posted Date: 2018-12-28

Last Posted Date: 2022-08-08

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 90

Registration Number: NCT03789214

Locations: 🇺🇸
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

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

Phase 4

Conditions: Chronic Insomnia

Interventions: Drug: Suvorexant
Drug: Placebo

First Posted Date: 2018-12-07

Last Posted Date: 2021-10-07

Lead Sponsor: Montana State University

Target Recruit Count: 34

Registration Number: NCT03768713

Locations: 🇺🇸
Montana State University, Bozeman, Montana, United States

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

Phase 4

Withdrawn

Conditions: Bipolar Disorder
Insomnia

Interventions: Drug: Suvorexant (Belsomra)
Drug: Placebo

First Posted Date: 2018-12-05

Last Posted Date: 2021-02-21

Lead Sponsor: Massachusetts General Hospital

Registration Number: NCT03764683

Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant

Phase 2

Conditions: Restless Legs Syndrome

Interventions: Drug: Placebo
Drug: Suvorexant

First Posted Date: 2018-11-27

Last Posted Date: 2018-11-29

Lead Sponsor: Diego García-Borreguero, MD, PhD

Target Recruit Count: 43

Registration Number: NCT03755310

Locations: 🇪🇸
Sleep Research Institute; Paseo de la Habana 151, Madrid, Spain

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

Phase 1

Completed

Conditions: Healthy Recreational Drug Users

Interventions: Drug: Suvorexant
Drug: Placebo
Drug: ACT-541468
Drug: Zolpidem

First Posted Date: 2018-09-05

Last Posted Date: 2019-09-19

Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Target Recruit Count: 63

Registration Number: NCT03657355

Locations: 🇨🇦
Altasciences Company Inc., Montreal, Canada
🇺🇸
Altasciences Clinical Kansas, Inc. (former Vince and Associates Clinical Research, Inc.), Overland Park, Kansas, United States

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

Phase 4

Recruiting

Conditions: Sleep Initiation and Maintenance Disorders
Stress Disorders, Posttraumatic

Interventions: Other: Placebo
Drug: Suvorexant

First Posted Date: 2018-08-22

Last Posted Date: 2024-07-08

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 144

Registration Number: NCT03642028

Locations: 🇺🇸
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC, Salisbury, North Carolina, United States
🇺🇸
San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, United States
🇺🇸
VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States

and more 1 locations

Drug Development Updates

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