8 completed, 2 not yet recruiting, 2 unknown, 1 recruiting. 13 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 8, Not yet recruiting 2, Unknown 2, Recruiting 1 |
| Phase 2 | 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 |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder HS-10506 - Insomnia Disorder | Phase 3 | Not yet recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 600 | 2026-06-12 | 2026-06-30 |
| A Study of HS-10506 in Chinese Patients With Insomnia Disorder HS-10506, Placebo - Insomnia Disorder | Phase 3 | Not yet recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 732 | 2026-05-29 | 2026-05-14 |
| Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia Tasimelteon Oral Suspension, Placebo - Insomnia Disorder | Phase 3 | Recruiting | Vanda Pharmaceuticals | 420 | 2025-04-21 | 2026-06-05 |
| 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 |
| A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder Daridorexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Nxera Pharma Korea Co., Ltd. | 164 | 2024-12-04 | 2026-01-21 |
| A Study of Daridorexant in Chinese Patients With Insomnia Disorder Daridorexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Jiangsu Simcere Pharmaceutical Co., Ltd. | 206 | 2023-08-28 | 2024-10-30 |
| Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder YZJ-1139 20mg, YZJ-1139 40mg, Placebo - Insomnia Disorder | Phase 3 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 1037 | 2021-12-17 | 2026-06-30 |
| 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 |
| Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg - Insomnia Disorder | Phase 3 | Completed | Idorsia Pharmaceuticals Ltd. | 804 | 2018-10-09 | 2022-03-02 |
| Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder Daridorexant 25 mg, Daridorexant 50 mg, Placebo - Insomnia Disorder | Phase 3 | Completed | Idorsia Pharmaceuticals Ltd. | 930 | 2018-06-04 | 2022-03-25 |
| Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep Daridorexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Idorsia Pharmaceuticals Ltd. | 924 | 2018-05-29 | 2022-03-25 |
| 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 |
| Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2) lemborexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Eisai Inc. | 971 | 2016-11-15 | 2020-02-06 |
Sleep Initiation and Maintenance Disorders (13)
Dyssomnias (13) · Mental Disorders (13) · Nervous System Diseases (13) · Sleep Disorders, Intrinsic (13) · Sleep Wake Disorders (13)
daridorexant (5) · Zolpidem (2) · Melatonin (1) · lemborexant (1)
Idorsia Pharmaceuticals Ltd. (3) · Jiangsu Hansoh Pharmaceutical Co., Ltd. (2) · Shanghai Haiyan Pharmaceutical Technology Co., Ltd. (2) · Ache Laboratorios Farmaceuticos S.A. (1) · Biolab Sanus Farmaceutica (1) · Eisai Inc. (1) · Jiangsu Simcere Pharmaceutical Co., Ltd. (1) · Nxera Pharma Korea Co., Ltd. (1) · Vanda Pharmaceuticals (1)
Germany (5) · United States (5) · Canada (4) · Poland (4) · South Korea (4) · China (3) · Finland (3) · Spain (3) · Belgium (2) · Bulgaria (2) · Denmark (2) · France (2) · Hungary (2) · Italy (2) · Sweden (2)
Mauro Crippa Jr. (1) · Yuping Wang, Doctor (1)
PMID 37526060, PMID 37796657, PMID 35065036, PMID 36054921, PMID 38644625, PMID 41217192, PMID 32585700, PMID 33576735, PMID 33636648, PMID 34077032, PMID 35220140, PMID 35254948, PMID 35402894, PMID 36098936, PMID 36484969, PMID 37286927, PMID 37339396, PMID 37477771, PMID 38302765, PMID 38748321, PMID 39823487, PMID 40288253, PMID 40557879, PMID 40660750, PMID 41506007, PMID 41938624
2015 (1)