38 completed, 12 recruiting, 9 unknown, 6 not yet recruiting. 37 Not applicable, 13 Phase 3, 12 Phase 2, 4 Phase 4, 3 Phase 1.
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 |
|---|---|---|---|---|---|---|
| Sleep MAPP in the Polytrauma/TBI System of Care Sleep MAPP Care Pathway - Insomnia Disorder, Mild Traumatic Brain Injury | Not applicable | Not yet recruiting | VA Office of Research and Development | 900 | 2027-01-01 | 2026-10-21 |
| Rumination-Tailored Guided Internet-Based CBT-I for University Students Guided Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I), Rumination-Tailored Rule-Based Personalized Feedback - Insomnia, Insomnia Disorder | Not applicable | Active not recruiting | Shahid Beheshti University of Medical Sciences | 70 | 2026-07-04 | 2026-07-14 |
| 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 |
| Does Style Matter: Comparison of Moderate- to Low-intensity Styles of Yoga Vinyasa yoga, Gentle yoga, Non-active control - Insomnia, Health Adult Subjects | Not applicable | Recruiting | Caitlin Cheruka | 42 | 2026-06-01 | 2026-08-13 |
| 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 |
| Inulin-Spirulina Co-intervention for Insomnia Disorder Inulin, Spirulina, Maltodextrin - Insomnia Disorder, Sleep Initiation and Maintenance Disorders | Not applicable | Not yet recruiting | First Affiliated Hospital of Zhejiang University | 180 | 2026-05-01 | 2026-05-19 |
| A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia Sleep Hygiene Education, Melatonin IR, 3 mg, Melatonin IR, 5 mg - Insomnia, Insomnia Disorder | Phase 4 | Recruiting | University of Pennsylvania | 1200 | 2026-05-01 | 2026-09-16 |
| Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension Auricular Acupuncture Therapy, Sham Auricular Acupuncture Group - Insomnia Disorder, Diabetes | Not applicable | Recruiting | Jiangsu Taizhou People's Hospital | 320 | 2026-04-22 | 2026-06-29 |
| Internet-Based Cognitive Behavioral Therapy for Insomnia in Persian-Speaking Adults Omid Internet-Based CBT-I Program - Insomnia Disorder, Chronic Insomnia | Not applicable | Completed | Rasool Hamidi Choolabi | 30 | 2026-02-21 | 2026-08-19 |
| Compound Ciwujia Granules in the Treatment of Insomnia Compound Ciwujia Granules group, Estazolam, Compound Ciwujia Granules and estazolam - Insomnia Disorder | Phase 4 | Not yet recruiting | Hui Zhu | 1200 | 2026-01-01 | 2025-12-29 |
| Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2 Cognitive Behavioral Therapy for Insomnia (CBT-I), Passive Body Heating (PBH) - Insomnia Disorder | Not applicable | Recruiting | University of California, San Francisco | 40 | 2025-09-29 | 2026-04-24 |
| Virtual Reality Relaxation for Insomnia Virtual reality relaxation intervention - Insomnia Disorder | Not applicable | Recruiting | Laval University | 30 | 2025-09-01 | 2026-06-05 |
| 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 |
| Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia Cognitive Behavioral Treatment for Insomnia (CBT-I), Lemborexant, Placebo - Insomnia Disorder | Not applicable | Recruiting | Laval University | 90 | 2025-04-01 | 2025-04-09 |
| 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 |
| Comparative Efficacy of BRT and CBT-I for Insomnia Cognitive behavioral therapy for insomnia (CBT-I), Bedtime restriction (BRT) - Insomnia Disorders, Insomnia Disorder | Not applicable | Recruiting | Christoph Nissen | 160 | 2025-03-10 | 2025-02-17 |
| Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study Cognitive Behavioral Therapy for Insomnia, Passive Body Heating (PBH) - Insomnia Disorder | Not applicable | Completed | University of California, San Francisco | 10 | 2025-02-07 | 2026-05-01 |
| Digital CBT-I for Chronic Insomnia digital CBT-I - Insomnia Chronic, Insomnia Disorder | Not applicable | Not yet recruiting | WELT corp | 120 | 2025-01-01 | 2024-11-19 |
| The Sleep Clinic Outcome and Practice Study Chronotherapy, Cognitive Behavioral Therapy for Insomnia - Insomnia Disorder, Circadian Rhythm Sleep Disorder | Not applicable | Recruiting | St. Olavs Hospital | 3400 | 2025-01-01 | 2026-07-20 |
| 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 |
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Sleep Initiation and Maintenance Disorders (69) · Stress Disorders, Post-Traumatic (4) · Psychological Well-Being (3) · Sleep Wake Disorders (3) · Anxiety Disorders (2) · Depressive Disorder (2) · Mood Disorders (2) · Rumination Syndrome (2) · Acquired Immunodeficiency Syndrome (1) · Alzheimer Disease (1) · Brain Concussion (1) · Chronic Pain (1) · Cognitive Dysfunction (1) · Depression (1) · Depressive Disorder, Major (1)
Dyssomnias (69) · Mental Disorders (69) · Nervous System Diseases (69) · Sleep Disorders, Intrinsic (69) · Sleep Wake Disorders (66) · Pathological Conditions, Signs and Symptoms (8) · Signs and Symptoms (7) · Trauma and Stressor Related Disorders (5) · Behavior (4) · Neurologic Manifestations (4) · Stress Disorders, Traumatic (4) · Mood Disorders (3) · Personal Satisfaction (3) · Brain Diseases (2) · Central Nervous System Diseases (2)
daridorexant (10) · Cognitive Behavioral Therapy (6) · Zolpidem (5) · lemborexant (3) · Autogenic Training (2) · Cannabinol (1) · Chronotherapy (1) · Diphenhydramine (1) · Doxepin (1) · Educational Status (1) · Estazolam (1) · Flurazepam (1) · Hypnotics and Sedatives (1) · Inulin (1) · Meditation (1)
Idorsia Pharmaceuticals Ltd. (8) · VA Office of Research and Development (6) · Laval University (5) · Jiangsu Hansoh Pharmaceutical Co., Ltd. (3) · Shanghai Haiyan Pharmaceutical Technology Co., Ltd. (3) · Eisai Inc. (2) · University of California, San Francisco (2) · University of Pennsylvania (2) · AB Biotek (1) · Ache Laboratorios Farmaceuticos S.A. (1) · Big Health Inc. (1) · Biolab Sanus Farmaceutica (1) · Caitlin Cheruka (1) · Christoph Nissen (1) · Dongfang Hospital Beijing University of Chinese Medicine (1)
United States (26) · Canada (11) · China (10) · Germany (10) · Spain (6) · Switzerland (6) · France (5) · South Korea (5) · Poland (4) · Sweden (4) · Finland (3) · Hungary (3) · Italy (3) · Australia (2) · Belgium (2)
Ashley E Mason, PhD (2) · Christi S. Ulmer, PhD (2) · Shira Maguen, PhD (2) · Adam R. Kinney, PhD OTR (1) · Brendon Yee, MBChB, FRACP, FCCP, PhD (1) · Camilla Hoyos, MPH, PhD (1) · Charles M Morin, PhD (1) · Charles Morin, PhD (1) · Christoph Nissen, Prof.Dr. (1)
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R34AT012767 (2), 2015 (1), 2023 (1), I01HX002350 (1), P30AG021332 (1)