42 completed, 14 recruiting, 4 unknown, 3 not yet recruiting. 69 Phase 2, 7 Phase 1, 4 Phase 3.
Follow Insomnia: new trials by email Literature Review of Insomnia trials Research Report on Insomnia
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 |
|---|---|---|---|---|---|---|
| THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer and Insomnia Biospecimen Collection, Placebo Administration, Single Agent Therapy - Insomnia, Malignant Solid Neoplasm | Phase 2 | Not yet recruiting | Mayo Clinic | 69 | 2026-10-01 | 2026-09-02 |
| Deep Sleep in Older Adults SleepSpaceRx CBT-I-IoT-AI, SleepEZ CBTi, Sleep Hygiene IoT - Insomnia, Insomnia Chronic | Phase 2 | Recruiting | Proactive Life Inc | 180 | 2026-09-30 | 2026-10-20 |
| Daridorexant for People With Insomnia and Alcohol Use Disorder Study Daridorexant, Placebo, Brief Counseling - Alcohol Use Disorder, Insomnia | Phase 2 | Not yet recruiting | Sterling McPherson | 205 | 2026-09-01 | 2026-07-14 |
| Understanding the Role of the Locus Coeruleus in Insomnia Dexmedetomidine, Placebo - Insomnia | Phase 2 | Recruiting | Woolcock Institute of Medical Research | 15 | 2026-08-12 | 2026-08-19 |
| Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder APSTZD 1, APSTZD 2, APSTZD 3 - Insomnia, Insomnia Chronic | Phase 2 | Recruiting | Apsen Farmaceutica S.A. | 222 | 2026-08-05 | 2026-08-21 |
| Mindfulness Meditation for Insomnia Instructed bedtime app-guided mindfulness meditation, Uninstructed app-guided mindfulness meditation, Sleep hygiene education - Sleep Initiation and Maintenance Disorders, Insomnia | Phase 1 / Phase 2 | Recruiting | Brigham and Women's Hospital | 30 | 2026-03-31 | 2026-06-23 |
| Ning Shen Dan Xiang Gao Fang for Heart-Kidney Disharmony Insomnia Ningshen Danxiang Donkey-hide Gelatin Medicated Paste, Ningshen Danxiang Agar Medicated Paste (agar as excipient) - Insomnia | Phase 2 | Not yet recruiting | Shanghai 7th People's Hospital | 60 | 2026-03-15 | 2026-04-01 |
| Resilience Enhancement Following Sleep Treatment Cognitive-behavioral therapy for insomnia (CBTi), CBTi + Savoring Meditation, CBTi + Pain Education - Chronic Low Back Pain (CLBP), Insomnia | Phase 2 | Recruiting | University of Virginia | 300 | 2025-12-16 | 2025-12-23 |
| Suvorexant for Treatment of AUD and PTSD Suvorexant, Placebo - Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD) | Phase 2 | Recruiting | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | 76 | 2025-07-16 | 2026-10-14 |
| Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects Placebo, Lemborexant 10 MG - Opioid Use Disorder, Opioid Use | Phase 2 | Recruiting | Virginia Commonwealth University | 100 | 2025-05-27 | 2026-07-09 |
| A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia. Lemborexant 10 MG, Placebo - Insomnia | Phase 2 | Recruiting | Woolcock Institute of Medical Research | 20 | 2025-05-13 | 2026-09-18 |
| Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse Experimental health intervention, Varenicline - Tobacco Use, Tobacco Cessation | Phase 2 | Recruiting | Yale University | 114 | 2025-04-21 | 2026-06-05 |
| Sleep to Reduce Incident Depression Effectively in Peripartum Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), Treatment-as-usual (TAU) - Insomnia, Depression | Phase 2 | Recruiting | Henry Ford Health System | 500 | 2024-12-10 | 2026-04-17 |
| Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection Telehealth cognitive behavioral therapy for insomnia (tCBT-I), Web-based cognitive behavioral therapy for insomnia (wCBT-I), Treatment as usual (TAU) - Multiple Sclerosis, Insomnia | Phase 2 | Recruiting | University of Kansas Medical Center | 90 | 2024-10-11 | 2026-10-13 |
| 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 |
| Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis Cognitive behavioral therapy for insomnia, Sleep and lifestyle education - Multiple Sclerosis, Insomnia | Phase 2 | Active not recruiting | University of Kansas Medical Center | 70 | 2024-07-30 | 2026-10-08 |
| 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 |
| Pimavanserin for Insomnia in Veterans With PTSD pimavanserin, Placebo - Post-traumatic Stress Disorder, Insomnia | Phase 2 | Recruiting | VA Office of Research and Development | 60 | 2023-12-28 | 2026-05-04 |
| 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 |
| 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 |
Showing 20 of 69. Sign in to see all of them.
Sleep Initiation and Maintenance Disorders (69) · Depression (5) · Sleep Wake Disorders (5) · Multiple Sclerosis (4) · Parasomnias (4) · Stress Disorders, Post-Traumatic (4) · Alcoholism (3) · Anxiety Disorders (3) · Fatigue (3) · Psychological Well-Being (3) · Autism Spectrum Disorder (2) · Bipolar Disorder (2) · Cognitive Dysfunction (2) · Depressive Disorder, Major (2) · Marijuana Abuse (2)
Dyssomnias (68) · Mental Disorders (68) · Nervous System Diseases (68) · Sleep Disorders, Intrinsic (68) · Sleep Wake Disorders (64) · Pathological Conditions, Signs and Symptoms (15) · Signs and Symptoms (12) · Behavior (9) · Neurologic Manifestations (8) · Chemically-Induced Disorders (7) · Substance-Related Disorders (7) · Autoimmune Diseases (5) · Autoimmune Diseases of the Nervous System (5) · Behavioral Symptoms (5) · Brain Diseases (5)
Cognitive Behavioral Therapy (6) · casopitant (3) · lemborexant (3) · suvorexant (3) · (1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid (2) · Cannabidiol (2) · Dexmedetomidine (2) · Melatonin (2) · Modafinil (2) · Quetiapine Fumarate (2) · Sleep (2) · daridorexant (2) · Actigraphy (1) · Agar (1) · Behavior Therapy (1)
GlaxoSmithKline (3) · University of Utah (3) · Brigham and Women's Hospital (2) · National Center for Complementary and Integrative Health (NCCIH) (2) · Pfizer (2) · Stanford University (2) · University of Kansas Medical Center (2) · University of Virginia (2) · Woolcock Institute of Medical Research (2) · All Natural Medicine Clinic, LLC (1) · Apsen Farmaceutica S.A. (1) · Arena Pharmaceuticals (1) · Biologische Heilmittel Heel GmbH (1) · Bod Australia (1) · Canopy Growth Corporation (1)
United States (45) · Canada (7) · Australia (4) · Germany (4) · China (2) · Netherlands (2) · Brazil (1) · Bulgaria (1) · Denmark (1) · Finland (1) · France (1) · Indonesia (1) · Ireland (1) · Israel (1) · Italy (1)
Gavin West, M.D. (2) · Allison G Harvey, PhD (1) · Andrew Lawrence (1) · Ann Reynolds, MD (1) · Benicio N Frey, MD, MSc, PhD (1) · Brendon Yee, MBChB, FRACP, FCCP, PhD (1) · Brendon Yee, MBChB, PhD (1) · Caitlin E Martin, MD (1) · Camilla Hoyos, MPH, PhD (1) · Chiang-Shan Li (1) · Christina S McCrae, PhD (1) · Christopher Gordon, PhD (1) · Claire C. Bourguet, Ph.D. (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 36999619, PMID 37883189, PMID 39167421, PMID 40165746, PMID 41151943, PMID 41490112, PMID 41626064, PMID 41630040, PMID 41942161, PMID 42414855
2015 (1), 2023 (1), IK2CX002363-01A1 (1), K07CA132916 (1), K23AT003678 (1), K23AT012475 (1), R01AT002490 (1), R01AT013240 (1), R01CA126968 (1), R01DA059483 (1), R01DA061285 (1), R21HL087831 (1), R21MH066131 (1), R43AG097205 (1)