MedPath

Lemborexant

Generic Name
Lemborexant
Brand Names
Dayvigo
Drug Type
Small Molecule
Chemical Formula
C22H20F2N4O2
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

Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects

Phase 2
Not yet recruiting
Conditions
Opioid Use Disorder
Opioid Use
Insomnia
Orexin Antagonist
Interventions
First Posted Date
2025-05-20
Last Posted Date
2025-05-20
Lead Sponsor
Virginia Commonwealth University
Target Recruit Count
100
Registration Number
NCT06981195
Locations
🇺🇸

VCU Institute for Drug and Alcohol Studies, Richmond, Virginia, United States

Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping

Phase 2
Not yet recruiting
Conditions
OSA - Obstructive Sleep Apnea
Interventions
First Posted Date
2025-04-15
Last Posted Date
2025-04-18
Lead Sponsor
Flinders University
Target Recruit Count
15
Registration Number
NCT06928766
Locations
🇦🇺

Flinders University, Adelaide Institute for Sleep Health, Bedford Park, South Australia, Australia

A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults with Insomnia.

Phase 2
Recruiting
Conditions
Insomnia
Interventions
First Posted Date
2025-03-25
Last Posted Date
2025-04-01
Lead Sponsor
Woolcock Institute of Medical Research
Target Recruit Count
20
Registration Number
NCT06823752
Locations
🇦🇺

Woolcock Institute of Medical Research, Macquarie Park, New South Wales, Australia

Lemborexant in Delayed Sleep Phase Syndrome

Phase 4
Recruiting
Conditions
Delayed Sleep Phase Syndrome
Interventions
Drug: Placebo
First Posted Date
2025-03-13
Last Posted Date
2025-04-24
Lead Sponsor
University of California, San Francisco
Target Recruit Count
15
Registration Number
NCT06874855
Locations
🇺🇸

University of California San Francisco, San Francisco, California, United States

Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)

Phase 2
Not yet recruiting
Conditions
Major Depressive Disorder(MDD)
Insomnia Comorbid to Psychiatric Disorder
Interventions
Other: Placebo
First Posted Date
2025-02-24
Last Posted Date
2025-02-24
Lead Sponsor
Unity Health Toronto
Target Recruit Count
30
Registration Number
NCT06843187
Locations
🇨🇦

St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

Not Applicable
Recruiting
Conditions
Insomnia Disorder
Interventions
Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I)
Drug: Placebo
First Posted Date
2025-01-16
Last Posted Date
2025-04-09
Lead Sponsor
Laval University
Target Recruit Count
90
Registration Number
NCT06779149
Locations
🇨🇦

Université Laval Centre d'étude des troubles du sommeil, Québec, Quebec, Canada

Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

Phase 2
Not yet recruiting
Conditions
Delirium - Postoperative
Cardiac Surgery
Cardiac Surgery Subjects
Orexin Antagonist
Feasibility Studies
Sleep
In-hospital Mortality
Interventions
Drug: Control (placebo) group
First Posted Date
2024-10-18
Last Posted Date
2025-04-23
Lead Sponsor
University of British Columbia
Target Recruit Count
60
Registration Number
NCT06648681
Locations
🇨🇦

St. Paul's Hospital, Vancouver, British Columbia, Canada

Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

Phase 3
Recruiting
Conditions
Sleep
Interventions
Drug: Placebo
First Posted Date
2024-07-11
Last Posted Date
2024-07-11
Lead Sponsor
Phramongkutklao College of Medicine and Hospital
Target Recruit Count
50
Registration Number
NCT06496282
Locations
🇹🇭

Phramongkutklao Hospital, Ratchathewi, Bangkok, Thailand

DORA and LP in Alzheimer's Disease Biomarkers

Phase 2
Recruiting
Conditions
Alzheimer Disease
Interventions
First Posted Date
2024-02-23
Last Posted Date
2024-11-27
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
201
Registration Number
NCT06274528
Locations
🇺🇸

Washington University in St. Louis, School of Medicine, Saint Louis, Missouri, United States

Lemborexant Treatment of Insomnia Linked to Epilepsy

Phase 3
Recruiting
Conditions
Epilepsy
Sleep
Interventions
Drug: Placebo
First Posted Date
2024-02-16
Last Posted Date
2025-02-13
Lead Sponsor
University of Manitoba
Target Recruit Count
26
Registration Number
NCT06262594
Locations
🇺🇸

Duke University, Durham, North Carolina, United States

🇨🇦

Health Sciences Centre, Winnipeg, Manitoba, Canada

© Copyright 2025. All Rights Reserved by MedPath