129 completed, 13 terminated, 9 unknown, 8 recruiting. 169 Phase 3, 18 Phase 2.
Follow Sleep Initiation and Maintenance Disorders: new trials by email Literature Review of Sleep Initiation and Maintenance Disorders trials Research Report on Sleep Initiation and Maintenance Disorders
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 |
| 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 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 |
| Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer Tiaoshen Anti-cancer Granules, Placebo Granules, Cognitive Behavioral Therapy for Insomnia - Ovarian Neoplasms Malignant, Sleep Initiation and Maintenance Disorders | Phase 2 / Phase 3 | Not yet recruiting | Shanghai Municipal Hospital of Traditional Chinese Medicine | 360 | 2026-05-01 | 2026-04-24 |
| Efficacy of Chronotherapeutic Combination for Major Depressive Episode With Insomnia AD + SHR + active LT and extended-release melatonin 2mg, AD + SHR + active LT and placebo melatonin, AD + SHR + placebo LT and extended-release melatonin 2mg - Major Depressive Disorder (MDD) With Insomnia | Phase 3 | Recruiting | Assistance Publique - Hôpitaux de Paris | 184 | 2026-01-28 | 2026-08-12 |
| Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma 10% urea lotion plus 1% cannabidiol, Control - Mediciine, Systemic Sclerosis (SSc) | Phase 3 | Recruiting | Khon Kaen University | 36 | 2025-11-05 | 2025-11-24 |
| A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) Suvorexant, Placebo - Insomnia | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 300 | 2025-10-09 | 2026-09-21 |
| 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 |
| Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer estazolam 1-2 mg, Auricular pressure bean combined with electroacupuncture - Cancer, Insomnia | Phase 3 | Recruiting | Qinghai Red Cross Hospital | 60 | 2025-03-01 | 2025-03-25 |
| Melatonin fOr CHronic bAck Pain (The MOCHA Trial) Melatonin 10 MG, Placebo - Back Pain Lower Back Chronic, Insomnia | Phase 3 | Completed | Odense University Hospital | 220 | 2024-12-11 | 2026-04-22 |
| 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 |
| Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo - Excessive Sleepiness, Shift-work Disorder | Phase 3 | Recruiting | Axsome Therapeutics, Inc. | 520 | 2024-08-01 | 2026-07-24 |
| A Study of Ramelteon in Chinese Patients With Chronic Insomnia Ramelteon, Ramelteon placebo - Chronic Insomnia | Phase 3 | Not yet recruiting | Nanjing Chia-tai Tianqing Pharmaceutical | 280 | 2024-08-01 | 2024-07-22 |
| Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia Sublingual Tablet - Chronic Insomnia | Phase 3 | Unknown | EMS | 358 | 2024-06-01 | 2023-09-07 |
| Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia Cannabidiol (CBD) Capsule 75mg, Placebo - Insomnia | Phase 3 | Active not recruiting | Avecho Biotechnology | 519 | 2024-05-16 | 2026-06-30 |
| Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia Melatonin, Quetiapine, Placebo - Psychiatric Disorders, Insomnia | Phase 2 / Phase 3 | Recruiting | Lone Baandrup | 255 | 2023-09-18 | 2025-04-24 |
| 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 |
| An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia SM-1, Placebo - Transient Insomnia | Phase 3 | Withdrawn | Sequential Medicine Ltd | 2023-05-01 | 2024-04-17 | |
| Acceptance Commitment Therapy for Caregivers of People with Memory Loss Acceptance and Commitment Therapy - Caregiver Burden, Behavioral and Psychiatric Symptoms of Dementia | Phase 3 | Completed | Utah State University | 121 | 2023-02-16 | 2024-12-06 |
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Sleep Wake Disorders (15) · Depressive Disorder, Major (9) · Parasomnias (8) · Depression (7) · Mental Disorders (6) · Alzheimer Disease (5) · Dyssomnias (5) · Sleep Disorders, Intrinsic (5) · Anxiety Disorders (4) · Attention Deficit Disorder with Hyperactivity (3) · Bipolar Disorder (3) · Fatigue (3) · Stress Disorders, Traumatic (3) · Substance-Related Disorders (3)
Nervous System Diseases (168) · Dyssomnias (164) · Sleep Disorders, Intrinsic (164) · Mental Disorders (163) · Sleep Wake Disorders (154) · Pathological Conditions, Signs and Symptoms (26) · Signs and Symptoms (24) · Neurologic Manifestations (18) · Mood Disorders (12) · Behavior (9) · Brain Diseases (9) · Central Nervous System Diseases (9) · Depressive Disorder (9) · Behavioral Symptoms (8) · Neurodegenerative Diseases (7)
Zolpidem (17) · ramelteon (17) · Eszopiclone (15) · gaboxadol (12) · Gabapentin (9) · Cognitive Behavioral Therapy (8) · Mirtazapine (7) · Melatonin (6) · SR 46349B (5) · daridorexant (5) · suvorexant (5) · Duration of Therapy (4) · Trazodone (4) · lemborexant (4) · volinanserin (4)
H. Lundbeck A/S (13) · Sanofi (12) · Merck Sharp & Dohme LLC (11) · Takeda (11) · Sumitomo Pharma America, Inc. (9) · Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (8) · Karolinska Institutet (4) · Astellas Pharma Inc (3) · Boehringer Ingelheim (3) · Brasilia University Hospital (3) · Eisai Co., Ltd. (3) · Eisai Inc. (3) · Idorsia Pharmaceuticals Ltd. (3) · Vanda Pharmaceuticals (3) · Assistance Publique - Hôpitaux de Paris (2)
United States (76) · Canada (18) · France (15) · Germany (15) · United Kingdom (12) · Australia (10) · Brazil (10) · Spain (10) · Sweden (10) · China (9) · Netherlands (9) · Czechia (8) · Finland (8) · Denmark (7) · Italy (7)
Atsushi Kamijo (2) · Doo-Heum Park, M.D., Ph.D. (2) · Jaap Lancee, PhD (2) · Seung-Chul Hong, M.D., Ph.D. (2) · Thomas Roth, PhD (2)
PMID 31926466, PMID 37796657, PMID 19327100, PMID 28265715, PMID 28427826, PMID 33189083, PMID 36529106, PMID 37526060, PMID 20191935, PMID 25266438, PMID 25526970, PMID 27198953, PMID 27397664, PMID 29112763, PMID 30522875, PMID 32351205, PMID 33210445, PMID 34077032, PMID 35065036, PMID 35254948, PMID 36054921, PMID 38644625, PMID 41217192, PMID 41938624, PMID 16709464, PMID 17138773, PMID 17519067, PMID 17803013, PMID 17996657, PMID 18220081, PMID 18691937, PMID 18691991, PMID 18840807, PMID 19017878, PMID 19054552, PMID 19090503, PMID 19284927, PMID 19294955, PMID 19403468, PMID 19910177, PMID 20098520, PMID 20155590, PMID 20571180, PMID 20712869, PMID 20861739, PMID 21091391, PMID 21208574, PMID 21397868, PMID 22003345, PMID 22200586
2004 (3), 2015 (3), 2023 (2), 2005 (1), 2008 (1), R01AR052368 (1), R01DA020479 (1), R01DK115468 (1), R01MH058853 (1), R01MH086758 (1), R01NR015226 (1), R34MH080958 (1), U01DA031784 (1)