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Lemborexant 10 mg

DRUG9 trials

Sponsors

Eisai Inc., Baylor College of Medicine, University of Minnesota, Woolcock Institute of Medical Research, Virginia Commonwealth University

Conditions

Alcohol Use DisorderAlzheimer DiseaseHealthy ParticipantsHealthy SubjectsInsomniaInsomnia DisorderIrregular Sleep-Wake Rhythm DisorderObstructive Sleep Apnea

Phase 1

Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
CompletedNCT02350309
Eisai Inc.Insomnia Disorder
Start: 2014-12-13End: 2015-04-21Updated: 2020-01-18
Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects
CompletedNCT02583451
Eisai Inc.Healthy Participants
Start: 2015-11-30End: 2017-02-28Updated: 2018-09-06
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
CompletedNCT03471871
Eisai Inc.Healthy Subjects, Obstructive Sleep Apnea
Start: 2018-02-21End: 2018-08-03Updated: 2020-02-17
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
CompletedNCT04647383
Eisai Inc.Pulmonary Disease, Chronic Obstructive, Respiration Disorders, Sleep Apnea, Obstructive
Start: 2021-01-06End: 2022-02-10Updated: 2023-10-10

Phase 2

Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
CompletedNCT03001557
Eisai Inc.Irregular Sleep-Wake Rhythm Disorder
Start: 2016-12-20End: 2020-04-17Updated: 2021-05-17
DORA and LP in Alzheimer's Disease Biomarkers
RecruitingNCT06274528
University of MinnesotaAlzheimer Disease
Start: 2024-03-11End: 2030-03-31Target: 201Updated: 2026-07-13
A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.
RecruitingNCT06823752
Woolcock Institute of Medical ResearchInsomnia
Start: 2025-05-13End: 2027-12-01Target: 20Updated: 2026-09-18
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects
RecruitingNCT06981195
Virginia Commonwealth UniversityInsomnia, Opioid Use, Opioid Use Disorder +1
Start: 2025-05-27End: 2029-07-30Target: 100Updated: 2026-07-09

Phase 3

Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep
CompletedNCT05458609
Baylor College of MedicineAlcohol Use Disorder
Start: 2023-02-09End: 2024-01-30Updated: 2026-03-24

Related Papers

Neurofunctional phenotyping to investigate the role of the orexin system at the intersection of opioid use disorder and insomnia: a protocol for a randomised, placebo-controlled clinical trial of lemborexant in patients with insomnia receiving buprenorphine.
2025-10-28
Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea.
2025-08-18
Respiratory safety of lemborexant in adult and elderly subjects with moderate‐to‐severe chronic obstructive pulmonary disease
Journal of Sleep Research2024-09-123 citations
Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials
Drugs & Aging2024-08-0910 citations
0388 Lemborexant Effect on Sleep Parameters in Adults with Moderate or Severe Chronic Obstructive Pulmonary Disease
SLEEP2024-04-20
A randomized, double-blind, placebo-controlled, crossover study of respiratory safety of lemborexant in moderate to severe obstructive sleep apnea.
2024-01-0112 citations
0364 The Effect of Lemborexant on Polysomnographic Sleep Parameters in Adults with Mild, Moderate, or Severe Obstructive Sleep Apnea
SLEEP2023-05-01
Assessment of morning sleep propensity with lemborexant in adults with insomnia disorder in a randomized, placebo-controlled crossover study
SLEEP Advances2021-03-015 citations
Long‐term safety and efficacy of lemborexant in subjects with irregular sleep‐wake rhythm disorder and Alzheimer’s disease dementia
Alzheimer s & Dementia2020-12-01
F1‐06‐04: RESPONSE TO TREATMENT WITH LEMBOREXANT: SUBJECTS WITH IRREGULAR SLEEP‐WAKE RHYTHM DISORDER AND ALZHEIMER'S DISEASE DEMENTIA
Alzheimer s & Dementia2019-07-014 citations
On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers
SLEEP2018-12-31225 citations