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Showing 1–10 of 10 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Lemborexant 5 mg Clear all
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 11, 2024 · Synced Sep 9, 2026, 4:31 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 11, 2021 · Synced Sep 9, 2026, 4:31 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 8, 2026 · Synced Sep 9, 2026, 4:31 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 16, 2021 · Synced Sep 9, 2026, 4:31 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 Jul 31, 2019 · Synced Sep 9, 2026, 4:31 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 9, 2023 · Synced Sep 9, 2026, 4:31 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 5, 2020 · Synced Sep 9, 2026, 4:31 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 17, 2020 · Synced Sep 9, 2026, 4:31 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 12, 2024 · Synced Sep 9, 2026, 4:31 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 16, 2020 · Synced Sep 9, 2026, 4:31 AM EDT