44 completed, 6 terminated, 3 recruiting, 3 unknown. 60 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 60 | Completed 44, Terminated 6, Recruiting 3, Unknown 3, Withdrawn 3, Active not recruiting 1 |
| Phase 2 | 4 | Completed 3, Recruiting 1 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary Insomnia Dexmedetomidine, Zolpidem, Placebo - Insomnia | Phase 3 | Unknown | The University of Hong Kong | 20 | 2022-09-01 | 2022-11-14 |
| Enhanced CBTi for Older Adult Sleep and Cognition CBTi with Application, CBTi, Sleep Hygiene Education - Insomnia, Alzheimers Disease Related Dementias | Phase 2 / Phase 3 | Completed | Penn State University | 60 | 2022-03-16 | 2024-04-12 |
| National Adaptive Trial for PTSD Related Insomnia Trazodone, Eszopiclone, Placebo - Insomnia | Phase 3 | Completed | VA Office of Research and Development | 673 | 2021-02-25 | 2026-06-03 |
| A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia LEM 5 mg, LEM 10 mg - Insomnia | Phase 3 | Completed | Eisai Inc. | 53 | 2019-07-15 | 2021-04-12 |
| A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia SAGE-217, Placebo - Major Depressive Disorder, Insomnia | Phase 3 | Terminated | Biogen | 87 | 2019-02-04 | 2023-11-29 |
| Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis Cognitive Behavioral Therapy for Insomnia, Trazodone, Placebo - Insomnia, End Stage Renal Disease | Phase 3 | Completed | University of Washington | 126 | 2018-09-19 | 2024-02-05 |
| Treatment With Benzodiazepine After Cardiac Surgery Brotizolam, placebo - Insomnia | Phase 3 | Unknown | Rambam Health Care Campus | 200 | 2016-12-01 | 2016-11-10 |
| Z-Drugs for Sleep Disorders in Alzheimer's Disease Zolpidem, Zoplicone, Placebo - Sleep, Sleep Disorders | Phase 3 | Completed | Brasilia University Hospital | 62 | 2016-10-01 | 2020-11-10 |
| Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) Lemborexant, Lemborexant-matched placebo, Zolpidem tartrate - Insomnia | Phase 3 | Completed | Eisai Inc. | 1006 | 2016-05-31 | 2024-11-12 |
| The Healthy Patterns Sleep Study Attention-Control Condition, Timed Activity Intervention - Dementia, Alzheimer Disease | Phase 3 | Completed | University of Pennsylvania | 421 | 2016-05-01 | 2024-07-26 |
| The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain CALPXT96 - Chronic Pain, Insomnia | Phase 3 | Withdrawn | 9305-9954 Quebec Inc | 2015-12-01 | 2017-04-26 | |
| Alternative Dosing Regimens in the Pharmacotherapy of Insomnia Amitriptyline, Zolpidem, Placebo - Insomnia | Phase 3 | Terminated | Philipps University Marburg | 23 | 2014-05-01 | 2018-03-09 |
| Online or Face-to-face Treatment for Insomnia? Cognitive behavioral treatment for insomnia - Insomnia | Phase 3 | Completed | VU University of Amsterdam | 90 | 2013-10-01 | 2014-12-30 |
| Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia In-person Cognitive Behavioral Therapy of Insomnia, Internet Cognitive Behavioral Therapy of Insomnia - Insomnia | Phase 3 | Completed | Daniel J. Taylor, Ph.D. | 185 | 2012-03-01 | 2025-04-17 |
| Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease ICBT, ICONTROL - Parkinson's Disease, Depression | Phase 3 | Completed | Karolinska Institutet | 150 | 2012-02-01 | 2015-02-13 |
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Sleep Initiation and Maintenance Disorders (60) · Sleep Wake Disorders (6) · Depression (5) · Depressive Disorder, Major (4) · Parasomnias (4) · Alzheimer Disease (3) · Mental Disorders (3) · Attention Deficit Disorder with Hyperactivity (2) · Parkinson Disease (2) · Anxiety Disorders (1) · Arthritis, Rheumatoid (1) · Asthma (1) · Behavior (1) · Bipolar Disorder (1) · Chronic Pain (1)
Sleep Disorders, Intrinsic (60) · Dyssomnias (59) · Nervous System Diseases (59) · Mental Disorders (57) · Sleep Wake Disorders (54) · Pathological Conditions, Signs and Symptoms (9) · Signs and Symptoms (8) · Neurologic Manifestations (7) · Behavioral Symptoms (6) · Brain Diseases (6) · Central Nervous System Diseases (6) · Behavior (5) · Mood Disorders (5) · Neurodegenerative Diseases (5) · Depressive Disorder (4)
Eszopiclone (10) · Zolpidem (6) · gaboxadol (5) · ramelteon (5) · Mirtazapine (4) · SR 46349B (3) · Trazodone (3) · Cognitive Behavioral Therapy (2) · Duration of Therapy (2) · Melatonin (2) · Quetiapine Fumarate (2) · lemborexant (2) · suvorexant (2) · Aging (1) · Amitriptyline (1)
Merck Sharp & Dohme LLC (6) · Sumitomo Pharma America, Inc. (6) · H. Lundbeck A/S (5) · Sanofi (3) · Brasilia University Hospital (2) · Eisai Inc. (2) · Neurocrine Biosciences (2) · Transcept Pharmaceuticals (2) · University of Pennsylvania (2) · Utrecht University (2) · 9305-9954 Quebec Inc (1) · Avecho Biotechnology (1) · Azidus Brasil (1) · Biogen (1) · Daniel J. Taylor, Ph.D. (1)
United States (28) · Canada (6) · Netherlands (5) · Australia (4) · Brazil (4) · France (4) · Germany (4) · United Kingdom (4) · China (3) · Spain (3) · Argentina (2) · Austria (2) · Chile (2) · Czechia (2) · Denmark (2)
Jaap Lancee, PhD (2) · Thomas Roth, PhD (2) · Andrew Krystal, MD (1) · Atsushi Kamijo (1) · Bettina K Doering, Dr. (1) · Brandon S Lu, MD, MS (1) · Carmen Schade-Brittinger (1) · Daniel Gartenberg, Ph.D. (1) · Daniel J Taylor, Ph.D. (1) · Daniel Taylor, Ph.D. (1) · Darren Mansfield (1) · Einstein F Camargos, MD, MsC (1)
PMID 20191935, PMID 25266438, PMID 17138773, PMID 19054552, PMID 19090503, PMID 20098520, PMID 20571180, PMID 20861739, PMID 21208574, PMID 22003345, PMID 22731653, PMID 24014057, PMID 24495406, PMID 24680372, PMID 26047890, PMID 26047892, PMID 26414893, PMID 26872077, PMID 26994361, PMID 27902836, PMID 28265715, PMID 28427826, PMID 28472528, PMID 29618098, PMID 31880796, PMID 32586427, PMID 33081705, PMID 33189083, PMID 33283264, PMID 33590823, PMID 33853394, PMID 34077032, PMID 34344312, PMID 34416369, PMID 34635802, PMID 35254948, PMID 36472134, PMID 37796657, PMID 38224591, PMID 39120786, PMID 39879708, PMID 41250112, PMID 41938624
2023 (2), 2005 (1), 2015 (1), R01DK115468 (1), R01MH086758 (1), R01NR015226 (1)