25 completed, 11 recruiting, 9 not yet recruiting, 2 terminated. 19 Phase 2, 16 Phase 1, 8 Phase 4, 7 Phase 3, 1 Not applicable.
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 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 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 |
| How Well and Safely Does Lemborexant Work for People Who Wake up at Night to Urinate (LENS) Lemborexant tablets, Placebo - Nocturia | Phase 4 | Not yet recruiting | University of Alberta | 35 | 2026-10-15 | 2026-09-25 |
| 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 for Sleep and Delirium Prevention in Elderly ICU Patients Lemborexant, Placebo - Sleep Disturbance, Delirium | Phase 4 | Recruiting | Mahidol University | 100 | 2026-09-01 | 2026-10-08 |
| 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 Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease Lemborexant, placebo - Parkinson's Disease, Insomnia | Phase 4 | Not yet recruiting | YangPan | 44 | 2026-08-19 | 2026-06-11 |
| A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders Lemborexant tablets - Insomnia, Psychiatric Disorders | Recruiting | Shanghai Mental Health Center | 121 | 2026-01-24 | 2026-02-18 | |
| 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 of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia Cognitive Behavioral Treatment for Insomnia (CBT-I), Lemborexant, Placebo - Insomnia Disorder | Not applicable | Recruiting | Laval University | 90 | 2025-04-01 | 2025-04-09 |
| Lemborexant Treatment of Insomnia Linked to Epilepsy Lemborexant, Placebo - Epilepsy, Sleep | Phase 3 | Recruiting | University of Manitoba | 26 | 2024-10-29 | 2025-02-13 |
| 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 |
| Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers Lemborexant, Placebo - Sleep | Phase 3 | Unknown | Phramongkutklao College of Medicine and Hospital | 50 | 2024-08-01 | 2024-07-11 |
| 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 |
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Sleep Initiation and Maintenance Disorders (22) · Sleep Apnea, Obstructive (5) · Sleep Disorders, Circadian Rhythm (3) · Alzheimer Disease (2) · Apnea (2) · Delirium (2) · Dementia (2) · Emergence Delirium (2) · Opioid-Related Disorders (2) · Parkinson Disease (2) · Alcoholism (1) · Behavior, Addictive (1) · Brain Neoplasms (1) · Chronic Pain (1) · Critical Illness (1)
Eisai Inc. (15) · Beijing Tiantan Hospital (4) · Eisai Co., Ltd. (4) · Chulalongkorn University (2) · University of California, San Francisco (2) · Virginia Commonwealth University (2) · Baylor College of Medicine (1) · Brendan Lucey (1) · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal (1) · Flinders University (1) · Guangdong Provincial People's Hospital (1) · Kurume University (1) · Laval University (1) · Mahidol University (1) · Nova Scotia Health Authority (1)
United States (21) · Canada (13) · China (5) · Japan (4) · Thailand (4) · Australia (2) · Germany (2) · Italy (2) · South Korea (2) · Spain (2) · United Kingdom (2) · Finland (1) · France (1) · Indonesia (1) · Mexico (1)
Andrew D Krystal, MD, MS (2) · Brendan Lucey, MD (2) · Sarocha Vivatvakin, MD (2) · Abisith Dechachongjumroen, MD (1) · Aric Prather, PhD (1) · Bin Zhang, MD (1) · Brendon Yee, MBChB, FRACP, FCCP, PhD (1) · Caitlin E Martin, MD (1) · Camilla Hoyos, MPH, PhD (1) · Charles M Morin, PhD (1) · Danny J Eckert, PhD (1) · David N Crockford, MD (1) · Emmanuel Mignot, MD, PhD (1) · Frederick G Moeller, MD (1)
PMID 34077032, PMID 35254948, PMID 37796657, PMID 39120786, PMID 40848323, PMID 41938624, PMID 30597112, PMID 31880796, PMID 32585700, PMID 33576735, PMID 33590823, PMID 33636648, PMID 35112665, PMID 35220140, PMID 35402894, PMID 35748777, PMID 36472134, PMID 37193566, PMID 37339396, PMID 37565541, PMID 37677076, PMID 38460107, PMID 38748321, PMID 39266012, PMID 39823487, PMID 39879708, PMID 40346496, PMID 41103818, PMID 41151943, PMID 41442783, PMID 42226892, PMID 42414855, PMID 42844407
2015 (2), 2017 (1), R01AG080551 (1), R01DA059483 (1), UG1DA050207 (1)