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ClinicalTrials.gov public records Last synced Oct 17, 2026, 3:35 AM EDT

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Showing 1–24 of 24 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: lemborexant Clear all
Completed Phase 3 Interventional Results available

Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep

NCT05458609
View directory record Official record
Conditions
Alcohol Use Disorder
Interventions
Lemborexant 10 mg, Naltrexone
Drug
Lead sponsor
Baylor College of Medicine
Other
Eligibility
18 Years to 65 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Mar 24, 2026 · Synced Oct 17, 2026, 3:35 AM EDT
Recruiting Phase 3 Interventional

Lemborexant Treatment of Insomnia Linked to Epilepsy

NCT06262594
View directory record Official record
Conditions
Epilepsy, Sleep
Interventions
Lemborexant, Placebo
Drug
Lead sponsor
University of Manitoba
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Feb 13, 2025 · Synced Oct 17, 2026, 3:35 AM EDT
Recruiting Phase 2 Interventional Accepts healthy volunteers

DORA and LP in Alzheimer's Disease Biomarkers

NCT06274528
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Lemborexant 10 mg, Lemborexant 20mg, Placebo
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
65 Years and older
Enrollment
201 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2030
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jul 13, 2026 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia

NCT04009577
View directory record Official record
Conditions
Insomnia
Interventions
LEM 5 mg, LEM 10 mg
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years and older
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
17
States / cities
Glendale, Arizona • Sacramento, California • San Diego, California + 14 more
Source: ClinicalTrials.gov public record
Updated Apr 12, 2021 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Results available

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

NCT04647383
View directory record Official record
Conditions
Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiration Disorders
Interventions
Placebo, Lemborexant 10 mg
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
45 Years to 90 Years
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
11
States / cities
Glendale, Arizona • San Diego, California • Brandon, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 10, 2023 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects

NCT03451110
View directory record Official record
Conditions
Healthy Subjects
Interventions
lemborexant, Loestrin, famotidine, fluconazole
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Sep 6, 2018 · Synced Oct 17, 2026, 3:35 AM EDT
Recruiting Phase 4 Interventional Accepts healthy volunteers

Lemborexant in Delayed Sleep Phase Syndrome

NCT06874855
View directory record Official record
Conditions
Delayed Sleep Phase Syndrome
Interventions
Lemborexant, Placebo
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2027
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Jun 5, 2026 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 3 Interventional Results available

Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

NCT02952820
View directory record Official record
Conditions
Insomnia Disorder
Interventions
lemborexant, Placebo
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years and older
Enrollment
971 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
42
States / cities
Chandler, Arizona • Rogers, Arkansas • Beverly Hills, California + 35 more
Source: ClinicalTrials.gov public record
Updated Feb 6, 2020 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 4 Interventional Results available

Lemborexant Shift Work Treatment Study

NCT05344443
View directory record Official record
Conditions
Shift-Work Related Sleep Disturbance
Interventions
Lemborexant, Placebo
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
20 Years to 60 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Feb 4, 2026 · Synced Oct 17, 2026, 3:35 AM EDT
Withdrawn Phase 2 Interventional Accepts healthy volunteers

Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

NCT05728736
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Lemborexant 25 mg, Placebo
Drug
Lead sponsor
Brendan Lucey
Other
Eligibility
60 Years to 80 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Nov 8, 2023 · Synced Oct 17, 2026, 3:35 AM EDT
Active, not recruiting No phase listed Observational Accepts healthy volunteers

A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population

NCT06744673
View directory record Official record
Conditions
Sleep Initiation and Maintenance Disorders, Pregnancy
Interventions
No Intervention
Other
Lead sponsor
Eisai Inc.
Industry
Eligibility
16 Years to 49 Years · Female only
Enrollment
861 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025
U.S. locations
1
States / cities
Nutley, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 19, 2025 · Synced Oct 17, 2026, 3:35 AM EDT
Recruiting Phase 2 Interventional

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

NCT06981195
View directory record Official record
Conditions
Opioid Use Disorder, Opioid Use, Insomnia, Orexin Antagonist
Interventions
Placebo, Lemborexant 10 MG
Drug
Lead sponsor
Virginia Commonwealth University
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Jul 9, 2026 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 3 Interventional Results available

Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

NCT02783729
View directory record Official record
Conditions
Insomnia
Interventions
Lemborexant, Lemborexant-matched placebo, Zolpidem tartrate, Zolpidem-matched placebo
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
55 Years and older
Enrollment
1,006 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
60
States / cities
Jasper, Alabama • Glendale, Arizona • Little Rock, Arkansas + 49 more
Source: ClinicalTrials.gov public record
Updated Nov 12, 2024 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects

NCT03440424
View directory record Official record
Conditions
Hepatic Impairment
Interventions
Lemborexant
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 79 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
2
States / cities
Miami, Florida • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Mar 20, 2020 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 4 Interventional

Lemborexant in Delayed Sleep Phase Syndrome

NCT05463861
View directory record Official record
Conditions
Delayed Sleep Phase Syndrome
Interventions
Lemborexant, Placebo
Drug
Lead sponsor
Stanford University
Other
Eligibility
18 Years and older
Enrollment
71 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Redwood City, California
Source: ClinicalTrials.gov public record
Updated Mar 2, 2026 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Results available

Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder

NCT02350309
View directory record Official record
Conditions
Insomnia Disorder
Interventions
Lemborexant 5 mg, Lemborexant 10 mg, Lemborexant-matched placebo., Flurazepam 30 mg
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 99 Years
Enrollment
69 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
2
States / cities
Atlanta, Georgia • Crestview Hills, Kentucky
Source: ClinicalTrials.gov public record
Updated Jan 18, 2020 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder

NCT04818086
View directory record Official record
Conditions
Drug Interaction, Analgesics, Opioid Use Disorder
Interventions
Lemborexant, Placebo, Buprenorphine-naloxone
Drug
Lead sponsor
Virginia Commonwealth University
Other
Eligibility
18 Years to 65 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Nov 13, 2024 · Synced Oct 17, 2026, 3:35 AM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

National Pregnancy Registry for Psychiatric Medications

NCT01246765
View directory record Official record
Conditions
Pregnant Women, Psychotropic Drugs
Interventions
Not listed
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
5,000 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2033
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 24, 2025 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women

NCT04890561
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Lemborexant
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Las Vegas, Nevada
Source: ClinicalTrials.gov public record
Updated Sep 5, 2021 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006

NCT01463098
View directory record Official record
Conditions
Insomnia
Interventions
E2006 1.0 mg, E2006 2.5 mg, E2006 5.0 mg, E2006 10.0 mg, E2006 25.0 mg, E2006 50.0 mg, E2006 100 mg, E2006 200 mg, Zolpidem 10 mg, E2006 Matched Placebo or Zolpidem Matched Placebo, E2006 Matched Placebo
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 64 Years
Enrollment
122 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
2
States / cities
New York, New York • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jan 18, 2020 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea

NCT03471871
View directory record Official record
Conditions
Obstructive Sleep Apnea, Healthy Subjects
Interventions
Placebo, Lemborexant 10 mg, Lemborexant 25 mg
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 90 Years
Enrollment
146 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
11
States / cities
Glendale, Arizona • Phoenix, Arizona • San Diego, California + 7 more
Source: ClinicalTrials.gov public record
Updated Feb 17, 2020 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older

NCT03008447
View directory record Official record
Conditions
Healthy Subjects
Interventions
LEM5, LEM10, ZOL, PBO
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
55 Years and older
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2018
U.S. locations
4
States / cities
Atlanta, Georgia • New York, New York • Raleigh, North Carolina + 1 more
Source: ClinicalTrials.gov public record
Updated Aug 1, 2019 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 2 Interventional Results available

Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

NCT03001557
View directory record Official record
Conditions
Irregular Sleep-Wake Rhythm Disorder
Interventions
Lemborexant 2.5 mg, Lemborexant 5 mg, Lemborexant 10 mg, Lemborexant 15 mg, Lemborexant-matched placebo
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
60 Years to 90 Years
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
37
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Costa Mesa, California + 30 more
Source: ClinicalTrials.gov public record
Updated May 17, 2021 · Synced Oct 17, 2026, 3:35 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment

NCT03443063
View directory record Official record
Conditions
Renal Impairment
Interventions
Lemborexant
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 79 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
2
States / cities
Miami, Florida • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Mar 12, 2020 · Synced Oct 17, 2026, 3:35 AM EDT