99 completed, 8 unknown, 7 recruiting, 7 terminated. 41 Phase 4, 27 Phase 1, 19 Phase 3, 18 Not applicable, 18 Phase 2.
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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 |
|---|---|---|---|---|---|---|
| Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients Standard Postoperative Care, Zolpidem, Melatonin - Orthopedic Trauma, Sleep Quality | Phase 3 | Recruiting | Emory University | 30 | 2026-06-02 | 2026-07-30 |
| A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia Sleep Hygiene Education, Melatonin IR, 3 mg, Melatonin IR, 5 mg - Insomnia, Insomnia Disorder | Phase 4 | Recruiting | University of Pennsylvania | 1200 | 2026-05-01 | 2026-09-16 |
| EFFECT OF ZOLPIDEM ON SLEEP QUALITY AND OPIOID CONSUMPTION FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL Zolpidem 10 mg tablets, Avocado-soybean unsaponifiables 300 mg - Postoperative Pain Management in Total Knee Arthroplasty | Phase 4 | Completed | Sanatorio Allende | 54 | 2025-08-05 | 2026-09-03 |
| Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder YZJ-1139, Zolpidem - Insomnia Disorder | Phase 3 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 61 | 2025-03-25 | 2026-06-29 |
| Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients 5-hydroxytryptamine balanced antidepressants trazodone, Citalopram hydrobromide combined with zolpidem - Depressed Insomniac Co-morbid Patients | Phase 4 | Recruiting | Tongji University | 60 | 2025-01-01 | 2025-02-19 |
| Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial Tizanidine Hcl 4Mg Tab, Zolpidem Tartrate 10 mg - Depressive Disorder, Major | Phase 4 | Not yet recruiting | Sultan Qaboos University | 90 | 2024-09-01 | 2024-03-12 |
| Improving Perioperative Sleep Disorders Pregabalin, Zolpidem - Sleep Disorder | Phase 1 | Completed | Mengchang Yang | 215 | 2024-07-02 | 2024-12-30 |
| Zolpidem's Effects on Road Cycling Performance Zolpidem 10 mg, Placebo - Healthy | Phase 4 | Completed | National Taiwan Normal University | 15 | 2024-06-26 | 2025-01-30 |
| Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal Suanzaoren Decoction and Huanglian Wendan Decoction, Zolpidem - Traditional Chinese Medicine, Sleep Disorder | Not applicable | Unknown | The First Affiliated Hospital with Nanjing Medical University | 106 | 2023-12-22 | 2024-02-06 |
| Psilocybin Therapy for Chronic Low Back Pain Psilocybin therapy with Zolpidem and Modafinil, Psilocybin therapy with Zolpidem, Psilocybin therapy with Modafinil - Chronic Low-back Pain | Phase 1 / Phase 2 | Active not recruiting | Joshua Woolley, MD, PhD | 30 | 2023-12-01 | 2026-04-29 |
| Zolpidem on CPAP Acclimatization in OSA Zolpidem, Placebo - Obstructive Sleep Apnea | Phase 4 | Unknown | Siriraj Hospital | 30 | 2023-10-15 | 2023-10-16 |
| Trial of Zolpidem for Sleep in Children With Autism Zolpidem, Placebo - Autism, Autism Spectrum Disorder | Phase 2 | Recruiting | Stanford University | 26 | 2023-08-09 | 2026-03-27 |
| Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms Experimental group: Shugan Jieyu Capsule combined with zolpidem, Control group: Placebo combined with zolpidem - Insomnia | Phase 1 | Unknown | Nanfang Hospital, Southern Medical University | 60 | 2022-11-30 | 2023-03-13 |
| Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary Insomnia Dexmedetomidine, Zolpidem, Placebo - Insomnia | Phase 3 | Unknown | The University of Hong Kong | 20 | 2022-09-01 | 2022-11-14 |
| CBT-I or Zolpidem/Trazodone for Insomnia Zolpidem, Internet Cognitive Behavioral Therapy for Insomnia (CBT-I), Trazodone - Chronic Insomnia | Phase 4 | Completed | California Pacific Medical Center Research Institute | 155 | 2022-02-25 | 2025-02-24 |
| The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion Zolpidem Tartrate 10 mg, Placebo - Spine Fusion, Lumbar Spine Degeneration | Phase 4 | Recruiting | University of Southern California | 140 | 2022-02-01 | 2026-05-01 |
| A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem Suvorexant, Zolpidem, Seltorexant - Healthy Non-dependent, Recreational Sedative Users, Abuse Potential | Phase 1 | Completed | Janssen Research & Development, LLC | 127 | 2021-12-17 | 2025-04-27 |
| Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder. Zolpidem - Insomnia Disorder | Phase 2 / Phase 3 | Unknown | Biolab Sanus Farmaceutica | 366 | 2021-03-01 | 2020-07-27 |
| Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment Acetazolamide + supplemental oxygen + PAP therapy, Zolpidem + PAP therapy, Buspirone + PAP therapy - Sleep Disordered Breathing, Able Bodied | Phase 4 | Recruiting | VA Office of Research and Development | 200 | 2021-01-07 | 2026-07-20 |
| Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: - Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension | Recruiting | Duke University | 5000 | 2020-03-05 | 2026-08-21 |
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Sleep Initiation and Maintenance Disorders (65) · Sleep Wake Disorders (16) · Depression (6) · Parasomnias (4) · Heart Failure (3) · Pain (3) · Sleep Apnea Syndromes (3) · Sleep Deprivation (3) · Alzheimer Disease (2) · Anxiety Disorders (2) · Arrhythmias, Cardiac (2) · Attention Deficit Disorder with Hyperactivity (2) · Autistic Disorder (2) · Dementia (2) · Hemophilia A (2)
Sanofi (10) · Astellas Pharma Inc (5) · University of Pennsylvania (4) · Eisai Inc. (3) · Idorsia Pharmaceuticals Ltd. (3) · Johns Hopkins University (3) · Massachusetts General Hospital (3) · Transcept Pharmaceuticals (3) · Duke University (2) · Eli Lilly and Company (2) · GlaxoSmithKline (2) · Janssen Research & Development, LLC (2) · Mclean Hospital (2) · Midnight Pharma, LLC (2) · Mutual Pharmaceutical Company, Inc. (2)
United States (73) · Canada (10) · China (8) · Germany (7) · United Kingdom (7) · France (6) · Japan (6) · Brazil (3) · Denmark (3) · Hungary (3) · India (3) · Israel (3) · Spain (3) · Argentina (2) · Australia (2)
Phyllis Diener (3) · Alan K Copa (2) · Daniel J. Buysse, MD (2) · Hadine Joffe, MD, MSC (2) · Michael L Perlis, PhD (2) · Shirley Ann Kennedy, M.D. (2) · Stephanie C Licata, PhD (2) · Thomas Roth, PhD (2)
PMID 10221356, PMID 10798794, PMID 17347797, PMID 1748108, PMID 18431116, PMID 18627623, PMID 19151617, PMID 19264040, PMID 19317379, PMID 19403468, PMID 19454639, PMID 19724732, PMID 20581790, PMID 20625114, PMID 21208597, PMID 21226678, PMID 21286241, PMID 21296508, PMID 21359104, PMID 21623982, PMID 21734685, PMID 22004689, PMID 22232986, PMID 22237311, PMID 23063301, PMID 23115404, PMID 23760468, PMID 24497220, PMID 24587571, PMID 24614374, PMID 24634631, PMID 24911577, PMID 24949994, PMID 25317090, PMID 26039810, PMID 26446253, PMID 26926644, PMID 26940892, PMID 27522443, PMID 27648659, PMID 27658218, PMID 27692272, PMID 28137820, PMID 28290120, PMID 28364426, PMID 28467857, PMID 28575467, PMID 28735928, PMID 28779462, PMID 28782982
2015 (2), 2017 (1), DP1OD003646 (1), I01CX001944 (1), K01DA023659 (1), K01MH080992 (1), K23MH066978 (1), M01RR000051 (1), P50HD109861 (1), R01AG054521 (1), R01AT003332 (1), R01HL130552 (1), R01MH024652 (1), R01MH060413 (1), R01MH062119 (1)