42 completed. 42 Phase 2, 4 Phase 1, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 42 | Completed 42 |
| Phase 1 | 4 | Completed 4 |
| Phase 3 | 3 | Completed 3 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| The CanISleepinMS Study: Effect of Cannabidiol (CBD) on Sleep Quality in Patients With Multiple Sclerosis Cannabidiol Oil - Sleep Quality, Multiple Sclerosis | Phase 2 | Completed | Wageningen University | 16 | 2024-03-26 | 2026-09-25 |
| Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes Baseline surveys, Cognitive testing and EMAs, Actiwatch, suvorexant (or placebo) - Insomnia | Phase 2 | Completed | University of Maryland, Baltimore | 40 | 2023-10-09 | 2025-10-30 |
| Neurexan - a Clinical Trial in Short-Term Insomnia Patients Neurexan, Placebo - Insomnia, Stress Reaction | Phase 2 | Completed | Biologische Heilmittel Heel GmbH | 81 | 2023-09-06 | 2026-03-03 |
| A Novel Wearable Device to Improve Sleep Quality Sleep Wellness Device (BeCurie) - Insomnia | Phase 2 | Completed | University of Utah | 59 | 2023-09-01 | 2025-03-28 |
| Cannabinoids as a Treatment for Insomnia in Major Depression 25:1 CBD/THC, 5:1 CBD/THC, Placebo - Insomnia, Depressive Disorder, Major | Phase 2 | Completed | St. Joseph's Healthcare Hamilton | 14 | 2023-08-28 | 2026-01-22 |
| Efficacy and Tolerability of Tasipimidine in Sleepless Patients Tasipimidine, Tasipimidine placebo - Insomnia | Phase 2 | Completed | Orion Corporation, Orion Pharma | 190 | 2023-08-20 | 2025-10-22 |
| Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg - Insomnia | Phase 2 | Completed | Idorsia Pharmaceuticals Ltd. | 166 | 2022-09-06 | 2026-03-06 |
| The CANabidiol Use for RElief of Short Term Insomnia 50 mg Cannabidiol (CBD), Placebo, 100 mg Cannabidiol (CBD) - Sleep Disturbance, Insomnia | Phase 2 | Completed | Bod Australia | 208 | 2022-05-01 | 2023-08-16 |
| Enhanced CBTi for Older Adult Sleep and Cognition CBTi with Application, CBTi, Sleep Hygiene Education - Insomnia, Alzheimers Disease Related Dementias | Phase 2 / Phase 3 | Completed | Penn State University | 60 | 2022-03-16 | 2024-04-12 |
| Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia Defined CBD, Placebo - Insomnia | Phase 2 | Completed | Defined Research | 125 | 2022-02-18 | 2025-09-11 |
| The Menopause After Cancer Study Citalopram +/- Gabapentin + Sleepio + support person - Menopause, Cancer | Phase 2 | Completed | University College Dublin | 205 | 2021-06-21 | 2023-01-06 |
| Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation V117957 tablets, Placebo - Insomnia | Phase 2 | Completed | Imbrium Therapeutics | 114 | 2019-09-23 | 2023-09-18 |
| 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 |
| Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric Comorbidity JNJ-42847922, Placebo - Insomnia | Phase 2 | Completed | Janssen Research & Development, LLC | 28 | 2015-07-27 | 2025-04-27 |
| Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia. TIAN WANG BU XIN DAN, Suan Tzao Ren Tang, Placebo - Insomnia | Phase 2 | Completed | Chung Shan Medical University | 128 | 2013-05-01 | 2016-01-20 |
| Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder Ferrous sulfate, Placebo - Autism Spectrum Disorder, Insomnia | Phase 2 | Completed | University of Colorado, Denver | 24 | 2012-12-01 | 2020-08-03 |
| Telephone Care Management to Address Sleep Problems in Young Children With Autism Telephone Care Management, Usual Care - Autism Spectrum Disorders, Insomnia | Phase 2 | Completed | Nationwide Children's Hospital | 60 | 2012-04-01 | 2015-02-03 |
| Management of Insomnia in Breast Cancer Patients BBT-I, Control, Armodafinil - Insomnia, Fatigue | Phase 2 | Completed | Stanford University | 70 | 2011-01-01 | 2018-11-29 |
| A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia Zaleplon AP formulation, Placebo capsule - Insomnia | Phase 2 | Completed | Intec Pharma Ltd. | 83 | 2011-01-01 | 2014-12-19 |
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Sleep Initiation and Maintenance Disorders (42) · Parasomnias (4) · Fatigue (3) · Psychological Well-Being (3) · Sleep Wake Disorders (3) · Autism Spectrum Disorder (2) · Depression (2) · Depressive Disorder, Major (2) · Anxiety Disorders (1) · Arrhythmias, Cardiac (1) · Breast Neoplasms (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 2 (1) · Fibrosis (1) · Fractures, Stress (1)
Dyssomnias (42) · Mental Disorders (42) · Nervous System Diseases (42) · Sleep Disorders, Intrinsic (42) · Sleep Wake Disorders (39) · Pathological Conditions, Signs and Symptoms (8) · Signs and Symptoms (6) · Behavior (4) · Neurologic Manifestations (3) · Personal Satisfaction (3) · Behavioral Symptoms (2) · Brain Diseases (2) · Central Nervous System Diseases (2) · Child Development Disorders, Pervasive (2) · Depressive Disorder (2)
Cognitive Behavioral Therapy (4) · casopitant (3) · Cannabidiol (2) · Modafinil (2) · (1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid (1) · Actigraphy (1) · Behavior Therapy (1) · Capsules (1) · Desensitization, Psychologic (1) · Dexmedetomidine (1) · Ecological Momentary Assessment (1) · Escitalopram (1) · Melatonin (1) · Mindfulness-Based Stress Reduction (1) · Neuropsychological Tests (1)
GlaxoSmithKline (3) · University of Utah (3) · National Center for Complementary and Integrative Health (NCCIH) (2) · Stanford University (2) · Arena Pharmaceuticals (1) · Biologische Heilmittel Heel GmbH (1) · Bod Australia (1) · Brigham and Women's Hospital (1) · Chung Shan Medical University (1) · Defined Research (1) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (1) · Idorsia Pharmaceuticals Ltd. (1) · Imbrium Therapeutics (1) · Intec Pharma Ltd. (1) · Janssen Research & Development, LLC (1)
United States (29) · Canada (5) · Germany (4) · Netherlands (2) · Australia (1) · Bulgaria (1) · China (1) · Finland (1) · France (1) · Indonesia (1) · Ireland (1) · Israel (1) · Italy (1) · Spain (1) · Switzerland (1)
Gavin West, M.D. (2) · Allison G Harvey, PhD (1) · Ann Reynolds, MD (1) · Benicio N Frey, MD, MSc, PhD (1) · Christina S McCrae, PhD (1) · Daniel Gartenberg, Ph.D. (1) · Daniel Taylor, Ph.D. (1) · Donal Brennan, PhD (1) · Donald L. Bliwise, PhD (1) · Doron Garfinkel, MD (1) · Emerson M Wickwire, PhD (1) · Gregory N Clarke, PhD (1)
PMID 41170811, PMID 10341379, PMID 11918106, PMID 14733976, PMID 17109795, PMID 17352947, PMID 17520797, PMID 17671050, PMID 17690599, PMID 18457236, PMID 18555170, PMID 19186083, PMID 19398354, PMID 19491110, PMID 20620105, PMID 21643649, PMID 23286463, PMID 25142566, PMID 25452447, PMID 25917009, PMID 29848147, PMID 30621831, PMID 30929703, PMID 33283264, PMID 33928908, PMID 34869938, PMID 37883189, PMID 39167421, PMID 40165746, PMID 41490112, PMID 41942161, PMID 42414855
2015 (1), K07CA132916 (1), K23AT003678 (1), R01AT002490 (1), R01CA126968 (1), R21HL087831 (1), R21MH066131 (1)