9 completed, 3 unknown. 12 Phase 2, 2 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 9, Unknown 3 |
| Phase 1 | 2 | Completed 1, Unknown 1 |
| Phase 3 | 2 | Unknown 2 |
Follow Insomnia Disorder: new trials by email Literature Review of Insomnia Disorder trials Research Report on Insomnia Disorder
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 |
|---|---|---|---|---|---|---|
| Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder HS-10506, Placebo - Insomnia Disorder | Phase 1 / Phase 2 | Unknown | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 312 | 2024-05-01 | 2024-04-23 |
| Cannabinol Use in Patients With Insomnia Disorder 30 mg Cannabinol (CBN), 300 mg Cannabinol (CBN), Placebo - Insomnia Disorder | Phase 1 / Phase 2 | Completed | Woolcock Institute of Medical Research | 20 | 2022-08-24 | 2024-02-06 |
| 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 |
| Apnea and Insomnia Relief Study Apnea and Insomnia Relief (AIR), Sleep Education (SE) - Sleep Apnea Syndromes, Insomnia Disorder | Phase 2 | Completed | VA Office of Research and Development | 36 | 2020-02-27 | 2026-03-12 |
| Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder YZJ-1139 10mg, YZJ-1139 20mg, YZJ-1139 40mg - Insomnia Disorder | Phase 2 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 300 | 2019-08-04 | 2024-11-08 |
| Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia CBT-I plus placebo, CBT-I plus Melatonin 3 mg, CBT-I plus Melatonin 5 mg - Insomnia Disorder | Phase 2 / Phase 3 | Unknown | Ache Laboratorios Farmaceuticos S.A. | 307 | 2018-03-22 | 2020-09-03 |
| Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder TS-142, Dose-matched Placebo to TS-142 - Insomnia Disorder | Phase 2 | Completed | Taisho Pharmaceutical Co., Ltd. | 24 | 2017-07-07 | 2025-02-28 |
| Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder Zolpidem - Insomnia Disorder | Phase 2 | Completed | Idorsia Pharmaceuticals Ltd. | 113 | 2017-02-15 | 2019-07-24 |
| Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder ACT-541468, Placebo - Insomnia Disorder | Phase 2 | Completed | Idorsia Pharmaceuticals Ltd. | 58 | 2016-11-28 | 2020-04-24 |
| Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder ACT-541468 5 mg, ACT-541468 10 mg, ACT-541468 25 mg - Insomnia Disorder | Phase 2 | Completed | Idorsia Pharmaceuticals Ltd. | 360 | 2016-10-04 | 2020-04-13 |
| The Effect of Individualised Homeopathic Treatment of Insomnia Disorder in Females Individualised Homeopathic Remedy - Insomnia Disorder | Phase 2 | Completed | University of Johannesburg | 10 | 2015-01-01 | 2016-05-17 |
| Internet-based Treatment for Chronic Insomnia Cognitive Behavioral Therapy - Insomnia, Insomnia Disorder | Phase 2 | Completed | University of Manitoba | 118 | 2006-09-01 | 2013-08-08 |
Sleep Initiation and Maintenance Disorders (12) · Sleep Apnea Syndromes (1) · Sleep Apnea, Central (1) · Sleep Apnea, Obstructive (1) · Stress Disorders, Post-Traumatic (1)
Dyssomnias (12) · Mental Disorders (12) · Nervous System Diseases (12) · Sleep Disorders, Intrinsic (12) · Sleep Wake Disorders (12) · Apnea (1) · Respiration Disorders (1) · Respiratory Tract Diseases (1) · Stress Disorders, Traumatic (1) · Trauma and Stressor Related Disorders (1)
Zolpidem (3) · daridorexant (2) · Cannabinol (1) · Cognitive Behavioral Therapy (1) · Melatonin (1) · TS-142 (1)
Idorsia Pharmaceuticals Ltd. (3) · Ache Laboratorios Farmaceuticos S.A. (1) · Biolab Sanus Farmaceutica (1) · Jiangsu Hansoh Pharmaceutical Co., Ltd. (1) · Shanghai Haiyan Pharmaceutical Technology Co., Ltd. (1) · Taisho Pharmaceutical Co., Ltd. (1) · University of Johannesburg (1) · University of Manitoba (1) · VA Office of Research and Development (1) · Woolcock Institute of Medical Research (1)
United States (4) · Germany (3) · China (2) · Australia (1) · Brazil (1) · Canada (1) · Hungary (1) · Israel (1) · Japan (1) · South Africa (1) · Spain (1) · Sweden (1)
Brendon Yee, MBChB, FRACP, FCCP, PhD (1) · Camilla Hoyos, MPH, PhD (1) · Janice Pellow, M.TechHom (1) · Lizabeth A Goldstein, PhD (1) · Mauro Crippa Jr. (1) · Norah Vincent, Ph.D. (1) · Sara Mangialaio, MD (1) · Toshiro Heya (1)
PMID 23286463, PMID 31953863, PMID 32341187, PMID 33131027, PMID 35296912, PMID 37477771, PMID 37526060, PMID 37612115, PMID 38302765, PMID 41698831