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Showing 1–18 of 18 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: E2006 Clear all
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 5, 2026, 10:31 PM EDT
Completed Phase 2 Interventional Results available

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia

NCT01995838
View directory record Official record
Conditions
Chronic Insomnia, Adults, Elderly
Interventions
E2006, Placebo
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
291 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
29
States / cities
Glendale, Arizona • Phoenix, Arizona • Fountain Valley, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jan 30, 2020 · Synced Sep 5, 2026, 10:31 PM 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 18, 2025 · Synced Sep 5, 2026, 10:31 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

An Open-label, Single-dose Study to Determine the Metabolism and Excretion of [14C]E2006 in Healthy Male Subjects

NCT02046213
View directory record Official record
Conditions
Metabolism and Excretion
Interventions
E2006
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Nov 2, 2015 · Synced Sep 5, 2026, 10:31 PM 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 11, 2024 · Synced Sep 5, 2026, 10:31 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion

NCT02085967
View directory record Official record
Conditions
Healthy Subjects
Interventions
rifampin 600 mg, itraconazole 200 mg, midazolam 2 mg with bupropion 75 mg, E2006
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
106 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Nov 2, 2015 · Synced Sep 5, 2026, 10:31 PM 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 19, 2020 · Synced Sep 5, 2026, 10:31 PM 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 17, 2020 · Synced Sep 5, 2026, 10:31 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects

NCT01673451
View directory record Official record
Conditions
CNS
Interventions
E2006, Placebo comparator
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2013
U.S. locations
2
States / cities
Culver City, California • Glendale, California
Source: ClinicalTrials.gov public record
Updated Oct 10, 2013 · Synced Sep 5, 2026, 10:31 PM 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 5, 2026, 10:31 PM 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 11, 2020 · Synced Sep 5, 2026, 10:31 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects

NCT02089412
View directory record Official record
Conditions
Healthy Subjects
Interventions
E2006
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
59 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Nov 2, 2015 · Synced Sep 5, 2026, 10:31 PM 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 5, 2026, 10:31 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects

NCT02039089
View directory record Official record
Conditions
Healthy Volunteers
Interventions
E2006 2.5 mg, E2006 10 mg, E2006 25 mg, Placebo
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
20 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated Nov 2, 2015 · Synced Sep 5, 2026, 10:31 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations

NCT01673880
View directory record Official record
Conditions
Insomnia
Interventions
E2006
Drug
Lead sponsor
Eisai Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated May 21, 2013 · Synced Sep 5, 2026, 10:31 PM 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 5, 2018 · Synced Sep 5, 2026, 10:31 PM 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 5, 2026, 10:31 PM 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 4, 2021 · Synced Sep 5, 2026, 10:31 PM EDT