14 completed, 2 not yet recruiting. 16 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 16 | Completed 14, Not yet recruiting 2 |
| Phase 2 | 4 | Completed 2, Not yet recruiting 2 |
Follow lemborexant: new trials by email Literature Review of lemborexant trials Research Report on lemborexant
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Lemborexant for Cannabis Use Disorder Lemborexant 10mg, Placebo, Brief Behavioural Intervention - Cannabis Use Disorder | Phase 1 / Phase 2 | Not yet recruiting | University of Calgary | 28 | 2026-11-01 | 2026-09-22 |
| The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold Lemborexant 5 MG [Dayvigo] Period 1, Placebo Period 1, Lemborexant 5 MG [Dayvigo] Period 2 - OSA - Obstructive Sleep Apnea | Phase 1 / Phase 2 | Not yet recruiting | Chulalongkorn University | 36 | 2026-09-01 | 2026-07-06 |
| Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1, Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2, Placebo Day 1 - OSA | Phase 1 / Phase 2 | Completed | Chulalongkorn University | 10 | 2023-02-01 | 2025-09-17 |
| A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women Lemborexant - Healthy Volunteers | Phase 1 | Completed | Eisai Inc. | 8 | 2021-05-17 | 2021-09-05 |
| Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder Lemborexant, Placebo, Buprenorphine-naloxone - Drug Interaction, Analgesics | Phase 1 / Phase 2 | Completed | Virginia Commonwealth University | 18 | 2021-05-03 | 2024-11-13 |
| 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 Placebo, Lemborexant 10 mg - Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive | Phase 1 | Completed | Eisai Inc. | 63 | 2021-01-06 | 2023-10-10 |
| A Single and Multiple Dose Study of Lemborexant in Healthy Chinese Participants Lemborexant - Healthy Volunteer | Phase 1 | Completed | Eisai Co., Ltd. | 26 | 2020-10-26 | 2021-07-19 |
| Study of Lemborexant-Alcohol Interaction in Healthy Subjects Lemborexant, Alcohol, Placebo - Healthy Subjects | Phase 1 | Completed | Eisai Inc. | 24 | 2018-03-12 | 2018-10-17 |
| Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea Placebo, Lemborexant 10 mg, Lemborexant 25 mg - Obstructive Sleep Apnea, Healthy Subjects | Phase 1 | Completed | Eisai Inc. | 146 | 2018-02-21 | 2020-02-17 |
| Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment Lemborexant - Renal Impairment | Phase 1 | Completed | Eisai Inc. | 16 | 2018-02-07 | 2020-03-12 |
| Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects lemborexant, Loestrin, famotidine - Healthy Subjects | Phase 1 | Completed | Eisai Inc. | 50 | 2018-02-05 | 2018-09-06 |
| Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects Lemborexant - Hepatic Impairment | Phase 1 | Completed | Eisai Inc. | 24 | 2018-01-26 | 2020-03-20 |
| A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users Zolpidem tablets, Suvorexant tablets, over-encapsulated, Lemborexant tablets - Insomnia Disorders | Phase 1 | Completed | Eisai Inc. | 39 | 2017-04-19 | 2020-06-29 |
| Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects Placebo tablet matching lemborexant, Placebo tablet matching zopiclone, Zopiclone 7.5 mg - Healthy Participants | Phase 1 | Completed | Eisai Inc. | 48 | 2015-11-01 | 2018-09-06 |
| Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder Lemborexant 5 mg, Lemborexant 10 mg, Lemborexant-matched placebo. - Insomnia Disorder | Phase 1 | Completed | Eisai Inc. | 69 | 2014-12-13 | 2020-01-18 |
| A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 E2006 1.0 mg, E2006 2.5 mg, E2006 5.0 mg - Insomnia | Phase 1 | Completed | Eisai Inc. | 122 | 2011-10-05 | 2020-01-18 |
Sleep Apnea, Obstructive (4) · Sleep Initiation and Maintenance Disorders (3) · Apnea (2) · Behavior, Addictive (1) · Marijuana Abuse (1) · Opioid-Related Disorders (1) · Pulmonary Disease, Chronic Obstructive (1) · Renal Insufficiency (1) · Respiration Disorders (1)
Eisai Inc. (11) · Chulalongkorn University (2) · Eisai Co., Ltd. (1) · University of Calgary (1) · Virginia Commonwealth University (1)
United States (9) · Canada (3) · Thailand (2) · China (1) · Netherlands (1)
Sarocha Vivatvakin, MD (2) · David N Crockford, MD (1) · Frederick G Moeller, MD (1) · Leah M Mayo, PhD (1) · Stephanie L Borgland, PhD (1)
PMID 40848323, PMID 30597112, PMID 35748777, PMID 37193566, PMID 37565541, PMID 37677076, PMID 39120786, PMID 39266012
UG1DA050207 (1)