7 not yet recruiting, 5 completed, 4 recruiting, 2 terminated. 19 Phase 2, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Not yet recruiting 7, Completed 5, Recruiting 4, Terminated 2, Withdrawn 1 |
| Phase 1 | 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 |
| Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation Lemborexant 5 mg, Placabo - Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 128 | 2026-11-01 | 2026-10-29 |
| Lemborexant on Perioperative Sleep Quality in Patients With Brain Tumor Undergoing Surgery Lemborexant 5 mg, placebo - Brain Neoplasms, Sleep Initiation and Maintenance Disorders | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 112 | 2026-11-01 | 2026-10-29 |
| Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery Lemborexant 5 mg, Placebo - Postoperative Sleep Disturbance, Thoracoscopic Surgery | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 130 | 2026-10-08 | 2026-10-20 |
| Lemborexant Use for Cognition Improvement in Postoperative Delirium in Elderly Patients: A Randomized Controlled Trial Lemborexant Pill, Placebo tablet - Postoperative Delirium | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 992 | 2026-09-01 | 2026-07-14 |
| 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 Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping Eszopiclone 3 mg, Placebo, Lemborexant 10mg - OSA - Obstructive Sleep Apnea | Phase 2 | Recruiting | Flinders University | 15 | 2025-10-31 | 2026-09-02 |
| Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects Placebo, Lemborexant 10 MG - Opioid Use Disorder, Opioid Use | Phase 2 | Recruiting | Virginia Commonwealth University | 100 | 2025-05-27 | 2026-07-09 |
| A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia. Lemborexant 10 MG, Placebo - Insomnia | Phase 2 | Recruiting | Woolcock Institute of Medical Research | 20 | 2025-05-13 | 2026-09-18 |
| Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients Lemborexant 5 mg, Control (placebo) group - Delirium - Postoperative, Cardiac Surgery | Phase 2 | Not yet recruiting | University of British Columbia | 60 | 2025-05-01 | 2025-04-23 |
| Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems Lemborexant, Placebo - Cirrhosis, Liver Cirrhosis | Phase 2 | Completed | Universitas Indonesia | 82 | 2024-10-01 | 2026-03-18 |
| Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD) Lemborexant, Placebo - Major Depressive Disorder(MDD), Insomnia Comorbid to Psychiatric Disorder | Phase 2 | Terminated | Unity Health Toronto | 30 | 2024-09-25 | 2026-07-30 |
| DORA and LP in Alzheimer's Disease Biomarkers Lemborexant 10 mg, Lemborexant 20mg, Placebo - Alzheimer Disease | Phase 2 | Recruiting | University of Minnesota | 201 | 2024-03-11 | 2026-07-13 |
| The Effects of Lemborexant on the Ability to Sleep During Daytime Lemborexant 5 MG [Dayvigo], Matching Placebo - Shift-Work Sleep Disorder | Phase 2 | Terminated | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | 5 | 2024-01-11 | 2026-05-28 |
| Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau Lemborexant 25 mg, Placebo - Alzheimer Disease | Phase 2 | Withdrawn | Brendan Lucey | 2023-03-01 | 2023-11-08 | |
| 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 Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder Lemborexant, PBO - Sleep Initiation and Maintenance Disorders | Phase 2 | Completed | Eisai Co., Ltd. | 65 | 2022-11-30 | 2025-07-03 |
| 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 |
| Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia Lemborexant 2.5 mg, Lemborexant 5 mg, Lemborexant 10 mg - Irregular Sleep-Wake Rhythm Disorder | Phase 2 | Completed | Eisai Inc. | 63 | 2016-12-20 | 2021-05-17 |
Sleep Initiation and Maintenance Disorders (7) · Sleep Apnea, Obstructive (3) · Alzheimer Disease (2) · Apnea (2) · Emergence Delirium (2) · Opioid-Related Disorders (2) · Behavior, Addictive (1) · Brain Neoplasms (1) · Delirium (1) · Dementia (1) · Depressive Disorder, Major (1) · Fibrosis (1) · Hepatic Encephalopathy (1) · Liver Cirrhosis (1) · Marijuana Abuse (1)
Beijing Tiantan Hospital (4) · Chulalongkorn University (2) · Virginia Commonwealth University (2) · Brendan Lucey (1) · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal (1) · Eisai Co., Ltd. (1) · Eisai Inc. (1) · Flinders University (1) · Unity Health Toronto (1) · Universitas Indonesia (1) · University of British Columbia (1) · University of Calgary (1) · University of Minnesota (1) · Woolcock Institute of Medical Research (1)
United States (5) · Canada (4) · Australia (2) · Thailand (2) · Indonesia (1) · Japan (1) · South Korea (1) · United Kingdom (1)
Brendan Lucey, MD (2) · Sarocha Vivatvakin, MD (2) · Brendon Yee, MBChB, FRACP, FCCP, PhD (1) · Caitlin E Martin, MD (1) · Camilla Hoyos, MPH, PhD (1) · Danny J Eckert, PhD (1) · David N Crockford, MD (1) · Frederick G Moeller, MD (1) · Leah M Mayo, PhD (1) · Pitt Akbar, MD, Internist (1) · Rino Alvani Gani, Professor, Internist, MD (1) · Stephanie L Borgland, PhD (1) · Venkat Bhat, MD, MSc (1)
2017 (1), R01AG080551 (1), R01DA059483 (1), UG1DA050207 (1)