Lemborexant

Generic Name: Lemborexant

Brand Names: Dayvigo

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₀F_₂N_₄O_₂

CAS Number: 1369764-02-2

Unique Ingredient Identifier: 0K5743G68X

Background: Lemborexant is a novel dual orexin receptor antagonist used in the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Recent research in the field of sleep disorders has revealed that insomnia is likely driven not by the inability of the brain to "switch on" sleep-related circuits, but rather an inability to "switch-off" wake-promoting circuits. Whereas historically popular pharmacologic treatments for insomnia (e.g. zopiclone, zolpidem, benzodiazepines) focus on enhancing sleep drive via modulation of GABA and melatonin receptors, lemborexant and other orexin antagonists (e.g. suvorexant) act to counteract inappropriate wakefulness. This novel mechanism of action offers potential advantages over classic hypnotic agents, including a more favorable adverse effect profile and potentially greater efficacy, and may signal the beginning of a new wave of treatment options for patients suffering from insomnia.

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

Associated Conditions: Insomnia

Clinical Trials

The Effects of Lemborexant on the Ability to Sleep During Daytime

Phase 2

Recruiting

Conditions: Shift-Work Sleep Disorder

Interventions: Drug: Lemborexant 5 MG [Dayvigo]
Other: Matching Placebo

First Posted Date: 2024-01-30

Last Posted Date: 2024-01-30

Lead Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Target Recruit Count: 24

Registration Number: NCT06231641

Locations: 🇨🇦
CIUSSS du Nord de l'ile de Montreal (CIUSSS-NIM) - Hôpital du Sacré-Cœur de Montréal (HSCM), Montréal, Quebec, Canada

Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia

Recruiting

Conditions: Insomnia

Interventions: Drug: Lemborexant 5 MG

First Posted Date: 2024-01-26

Last Posted Date: 2024-07-30

Lead Sponsor: Guangdong Provincial People's Hospital

Target Recruit Count: 200

Registration Number: NCT06225947

Locations: 🇨🇳
Clifford Hospital, Guangzhou, Guangdong, China
🇨🇳
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
🇨🇳
Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, China

and more 2 locations

Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial

Phase 4

Recruiting

Conditions: Frontotemporal Dementia
Insomnia
Dementia

Interventions: Drug: Lemborexant 5 MG

First Posted Date: 2023-10-23

Last Posted Date: 2025-02-21

Lead Sponsor: Nova Scotia Health Authority

Target Recruit Count: 1

Registration Number: NCT06093126

Locations: 🇨🇦
Nova Scotia Health, Halifax, Nova Scotia, Canada

Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold

Phase 1

Recruiting

Conditions: OSA

Interventions: Drug: Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2
Drug: Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1
Drug: Placebo Day 1
Drug: Placebo Day 2

First Posted Date: 2023-03-10

Last Posted Date: 2025-02-20

Lead Sponsor: Chulalongkorn University

Target Recruit Count: 10

Registration Number: NCT05763329

Locations: 🇹🇭
Chulalongkorn University, Pathum Wan, Bangkok, Thailand

Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

Phase 2

Withdrawn

Conditions: Alzheimer Disease

Interventions: Drug: Lemborexant 25 mg
Drug: Placebo

First Posted Date: 2023-02-15

Last Posted Date: 2023-11-08

Lead Sponsor: Brendan Lucey

Registration Number: NCT05728736

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

Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

Recruiting

Conditions: Chronic Insomnia
Chronic Pain

First Posted Date: 2022-11-16

Last Posted Date: 2025-01-27

Lead Sponsor: Salem Anaesthesia Pain Clinic

Target Recruit Count: 150

Registration Number: NCT05618002

Locations: 🇨🇦
Salem Anaesthesia Pain Clinic, Surrey, British Columbia, Canada

A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder

Phase 2

Completed

Conditions: Sleep Initiation and Maintenance Disorders

Interventions: Other: PBO
Drug: Lemborexant

First Posted Date: 2022-10-26

Last Posted Date: 2024-11-19

Lead Sponsor: Eisai Co., Ltd.

Target Recruit Count: 65

Registration Number: NCT05594589

Locations: 🇰🇷
Keimyung University Dongsan Hospital, Daegu-si, Korea, Republic of
🇰🇷
Gacheon University Gil Medical Centre, Incheon, Korea, Republic of
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

and more 6 locations