35 completed. 35 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 35 | Completed 35 |
| Phase 2 | 4 | Completed 4 |
Follow Insomnia: new trials by email Literature Review of Insomnia trials Research Report on Insomnia
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 |
|---|---|---|---|---|---|---|
| A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets YZJ-1139 tablets, Escitalopram oxalate tablets, YZJ-1139 simulated tablets - Insomnia, Central Nervous System | Phase 1 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 24 | 2024-08-31 | 2026-06-30 |
| A Drug-drug Interaction Study of YZJ-1139 Tablets and Ticagrelor Tablets in Healthy Subjects YZJ-1139 tablets, Ticagrelor Tablets - Insomnia | Phase 1 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 27 | 2024-08-22 | 2026-06-30 |
| Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment YZJ-1139 - Insomnia, Renal Impairment | Phase 1 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 16 | 2024-06-03 | 2026-06-30 |
| Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Mild, Moderate and Normal Hepatic Impairment YZJ-1139 - Insomnia, Hepatic Impairment | Phase 1 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 24 | 2024-03-22 | 2024-11-04 |
| Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) transauricular Vagus Nerve Stimulation - Breast Cancer, Insomnia | Phase 1 | Completed | University of Alabama at Birmingham | 20 | 2023-09-26 | 2026-06-18 |
| the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets Food, HEC83518, placebo - Insomnia | Phase 1 | Completed | Sunshine Lake Pharma Co., Ltd. | 57 | 2021-01-18 | 2026-05-01 |
| The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects HEC83518 tablets, Placebo - Insomnia | Phase 1 | Completed | Sunshine Lake Pharma Co., Ltd. | 74 | 2020-04-01 | 2026-05-01 |
| PK/PD Study of YZJ-1139 YZJ-1139, Placebo, Zolpidem - Insomnia | Phase 1 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 20 | 2019-03-07 | 2024-11-12 |
| A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of YZJ-1139 in Healthy Participants YZJ-1139, Placebo - Insomnia | Phase 1 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 104 | 2017-12-01 | 2025-02-10 |
| Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic Dexmedetomidine, Saline Placebo - Sleep, Insomnia | Phase 1 / Phase 2 | Completed | Massachusetts General Hospital | 15 | 2016-10-01 | 2019-10-02 |
| Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia propofol injectable emulsion - Insomnia, Sleep Disorder | Phase 1 | Completed | Life Extension Foundation Inc. | 2 | 2013-06-01 | 2016-08-30 |
| Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations E2006 - Insomnia | Phase 1 | Completed | Eisai Inc. | 40 | 2012-08-01 | 2013-05-22 |
| 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 |
| Gabapentin's Effects on Insomnia in Patients With Recent Concussion Gabapentin - Insomnia | Phase 1 | Completed | State University of New York at Buffalo | 21 | 2011-08-01 | 2023-02-14 |
| A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1) MK-4305 40 mg, MK-4305 20 mg, Zopiclone - Insomnia | Phase 1 | Completed | Merck Sharp & Dohme LLC | 28 | 2011-04-01 | 2016-02-22 |
| Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032) suvorexant, Placebo - Insomnia | Phase 1 | Completed | Merck Sharp & Dohme LLC | 25 | 2011-03-25 | 2018-09-21 |
| Effects of Insomnia on Simulated Driving (MK-0000-183-00) Placebo/ethanol (blinded) - Insomnia | Phase 1 | Completed | Merck Sharp & Dohme LLC | 76 | 2010-10-01 | 2019-06-12 |
| Effect of Activated Charcoal and Time of Dose on the Pharmacokinetics of LY2624803 in Healthy Subject LY2624803, Activated Charcoal - Insomnia | Phase 1 | Completed | Eli Lilly and Company | 21 | 2010-10-01 | 2011-12-22 |
| Safety and Pharmacokinetic Study of Sublingual Flumazenil (CRLS035) in Healthy Adults Flumazenil - Insomnia | Phase 1 | Completed | Coeruleus Ltd. | 10 | 2010-07-01 | 2015-01-30 |
| Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet zopiclone, zolpidem tartrate sublingual tablet, Placebo (sublingual tablet) - Insomnia | Phase 1 | Completed | Transcept Pharmaceuticals | 40 | 2010-06-01 | 2012-02-14 |
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Sleep Initiation and Maintenance Disorders (35) · Parasomnias (2) · Sleep Deprivation (2) · Sleep Wake Disorders (2) · Autistic Disorder (1) · Brain Concussion (1) · Breast Neoplasms (1) · Chronic Pain (1) · Dyssomnias (1) · Hepatic Insufficiency (1) · Pulmonary Disease, Chronic Obstructive (1) · Renal Insufficiency (1)
Mental Disorders (35) · Nervous System Diseases (35) · Sleep Disorders, Intrinsic (35) · Dyssomnias (34) · Sleep Wake Disorders (33) · Pathological Conditions, Signs and Symptoms (4) · Neurologic Manifestations (3) · Signs and Symptoms (3) · Autism Spectrum Disorder (1) · Brain Diseases (1) · Brain Injuries (1) · Brain Injuries, Traumatic (1) · Breast Diseases (1) · Central Nervous System Diseases (1) · Child Development Disorders, Pervasive (1)
Zolpidem (5) · suvorexant (4) · zopiclone (3) · Eszopiclone (2) · ramelteon (2) · (1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid (1) · Administration, Sublingual (1) · Charcoal (1) · Cognitive Behavioral Therapy (1) · Dexmedetomidine (1) · Escitalopram (1) · Ethanol (1) · Flumazenil (1) · Food (1) · Gabapentin (1)
Shanghai Haiyan Pharmaceutical Technology Co., Ltd. (6) · Merck Sharp & Dohme LLC (5) · Eisai Inc. (2) · Sunshine Lake Pharma Co., Ltd. (2) · University of Utah (2) · Coeruleus Ltd. (1) · Eisai Co., Ltd. (1) · Eli Lilly and Company (1) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (1) · Life Extension Foundation Inc. (1) · Massachusetts General Hospital (1) · Midnight Pharma, LLC (1) · National Institute of Nursing Research (NINR) (1) · Neurim Pharmaceuticals Ltd. (1) · Pfizer (1)
United States (13) · China (8) · Netherlands (4) · United Kingdom (4) · Israel (2) · Austria (1) · Denmark (1) · Finland (1) · France (1) · Germany (1) · Japan (1) · Spain (1) · Sweden (1) · Switzerland (1)
Gavin West, M.D. (2) · Alexandra Evancho, DPT (1) · Annemiek Vermeeren, PhD (1) · Aziz Laurent (1) · Beth A Malow, MD, MS (1) · Deborah Metzger, MD (1) · Dr. Daryl Bendel, MBChB (1) · Dr. Malgorzata Knurowska, MD (1) · Edward A Czinn, M.D. (1) · Eleornora Chiossi, MSc (1) · Fabrice Kramer, MD (1) · Georg Dorffner, Prof. Dr. (1) · Jasper Dingemanse, PhD (1)
PMID 21966064, PMID 22549286, PMID 24587571, PMID 25661282, PMID 26240742, PMID 41345210, PMID 42482263
R21NR009080 (1)