46 completed, 9 terminated, 6 recruiting, 5 not yet recruiting. 75 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 75 | Completed 46, Terminated 9, Recruiting 6, Not yet recruiting 5, Unknown 5, Withdrawn 3, Active not recruiting 1 |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 |
|---|---|---|---|---|---|---|
| Suvorexant 3 - PE-PC Suvorexant, Placebo, Prolonged Exposure Therapy for Primary Care (PE-PC) - PTSD - Post Traumatic Stress Disorder, Insomnia | Phase 4 | Not yet recruiting | Northern California Institute of Research and Education | 142 | 2026-09-01 | 2026-07-07 |
| Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease Lemborexant, placebo - Parkinson's Disease, Insomnia | Phase 4 | Not yet recruiting | YangPan | 44 | 2026-08-19 | 2026-06-11 |
| The Effects of Orexin Antagonism on Fear Extinction in PTSD Suvorexant, Placebo - Insomnia, PTSD | Phase 4 | Recruiting | VA Office of Research and Development | 40120 | 2026-07-01 | 2026-11-05 |
| 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 |
| Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia Daridorexant 50 mg, Placebo - Insomnia, Major Depressive Disorder | Phase 4 | Not yet recruiting | Institut d'Investigació Biomèdica de Bellvitge | 134 | 2026-04-01 | 2026-04-29 |
| Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms Cognitive behavioral therapy for insomnia (CBT-i), Trazodone, Daridorexant - Menopausal Women, Insomnia | Phase 4 | Recruiting | Brigham and Women's Hospital | 1000 | 2026-02-13 | 2026-06-08 |
| Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking Daridorexant 50 mg, Placebo - Smoking, Nicotine | Phase 4 | Not yet recruiting | Legacy Health System | 44 | 2026-02-10 | 2026-01-09 |
| No More Sleepless Nights in Perimenopause Cognitive Behavioural Therapy for Insomnia (CBT-I), Hormone Replacement Therapy (HRT), Sleep Hygiene - Insomnia, Menopause | Phase 4 | Recruiting | Insel Gruppe AG, University Hospital Bern | 54 | 2026-01-01 | 2026-01-13 |
| Sleeping Through Menopause Estrogens and Progestogens, Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy - Menopause, Insomnia | Phase 4 | Not yet recruiting | VU University of Amsterdam | 222 | 2025-10-01 | 2025-08-24 |
| Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults. Dolutegravir (DTG), Darunavir/Cobicistat (FDC) - HIV, Insomnia | Phase 4 | Unknown | Instituto Mexicano del Seguro Social | 140 | 2025-06-19 | 2025-06-26 |
| Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN) Eszopiclone 3 mg, Placebo - Insomnia, Hypertension | Phase 4 | Recruiting | University of Sao Paulo | 150 | 2025-06-04 | 2025-06-12 |
| Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients Best Practice, Electronic Health Record Review, Interview - Advanced Malignant Solid Neoplasm, Delirium | Phase 4 | Withdrawn | Mayo Clinic | 2025-02-26 | 2025-05-01 | |
| Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors Suvorexant Tablets, Placebo Control - Breast Cancer, Insomnia | Phase 4 | Terminated | Medical University of South Carolina | 6 | 2024-09-20 | 2026-08-12 |
| Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial Lemborexant 5 MG - Insomnia, Dementia | Phase 4 | Recruiting | Nova Scotia Health Authority | 1 | 2023-12-11 | 2025-02-21 |
| An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia Chloral Hydrate - Insomnia, Insomnia Chronic | Phase 4 | Completed | Pharmanovia | 100 | 2023-09-01 | 2024-11-07 |
| Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA Eszopiclone 3 mg, Placebo - Obstructive Sleep Apnea, Insomnia | Phase 4 | Completed | University of Sao Paulo General Hospital | 60 | 2023-08-24 | 2026-05-29 |
| Solriamfetol and CBT-I in Patients With Insomnia Disorder Solriamfetol 75 MG, Cognitive Behavioral Therapy for Insomnia (CBT-I), Monitoring - Insomnia | Phase 4 | Completed | University of Pennsylvania | 115 | 2023-07-31 | 2026-05-12 |
| Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia Suvorexant, Placebo - Insomnia, Metabolic Health | Phase 4 | Completed | Brigham and Women's Hospital | 31 | 2023-01-06 | 2026-04-16 |
| Insomnia Prevalence and Treatment Impact on Systemic Hypertension Ramelteon (RozeremR), sleep hygiene - Insomnia, Hypertension | Phase 4 | Terminated | University of Sao Paulo | 5 | 2022-05-01 | 2022-12-29 |
| Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia Suvorexant, Placebo - Restless Legs Syndrome, Insomnia | Phase 4 | Completed | Massachusetts General Hospital | 46 | 2021-08-12 | 2024-01-16 |
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Sleep Initiation and Maintenance Disorders (75) · Sleep Wake Disorders (7) · Depressive Disorder, Major (6) · Stress Disorders, Post-Traumatic (5) · Anxiety Disorders (4) · Depression (4) · Attention Deficit Disorder with Hyperactivity (3) · Fatigue (3) · Hypertension (3) · Bipolar Disorder (2) · Brain Injuries, Traumatic (2) · Delirium (2) · Fibromyalgia (2) · Hot Flashes (2) · Parasomnias (2)
Dyssomnias (75) · Nervous System Diseases (75) · Sleep Disorders, Intrinsic (75) · Mental Disorders (74) · Sleep Wake Disorders (68) · Pathological Conditions, Signs and Symptoms (15) · Signs and Symptoms (15) · Neurologic Manifestations (11) · Central Nervous System Diseases (8) · Mood Disorders (8) · Behavior (7) · Brain Diseases (7) · Depressive Disorder (6) · Stress Disorders, Traumatic (5) · Trauma and Stressor Related Disorders (5)
suvorexant (19) · Eszopiclone (12) · Zolpidem (12) · ramelteon (8) · Cognitive Behavioral Therapy (5) · Sugars (5) · Trazodone (3) · daridorexant (3) · lemborexant (3) · Atomoxetine Hydrochloride (2) · Doxepin (2) · Escitalopram (2) · Hormone Replacement Therapy (2) · Temazepam (2) · zopiclone (2)
Sanofi (4) · Brigham and Women's Hospital (3) · Duke University (3) · Massachusetts General Hospital (3) · University of Pennsylvania (3) · Astellas Pharma Inc (2) · Henry Ford Health System (2) · Rhode Island Hospital (2) · Sumitomo Pharma America, Inc. (2) · Takeda (2) · University of Sao Paulo (2) · Augusta University (1) · Baylor College of Medicine (1) · Beth Israel Deaconess Medical Center (1) · Burdick, Daniel, M.D. (1)
United States (50) · Japan (5) · Brazil (3) · Canada (3) · Norway (2) · China (1) · Spain (1) · Switzerland (1) · United Kingdom (1)
Phyllis Diener (3) · Andrew Krystal, MD (2) · Michael L Perlis, PhD (2) · Albert J Arias, MD, MS (1) · Ali El Solh, MD (1) · Andrea H. Weinberger, Ph.D. (1) · Andrew D Krystal, MD (1) · Angelo Sambunaris, MD (1) · Anthony Lequerica, PhD (1) · Balachundhar Subramaniam (1) · Birit Broekman, Prof. (1) · Bruno Jolain (1) · Cara Tannenbaum, MD (1) · Chris L Drake, PhD (1)
PMID 15683149, PMID 16804151, PMID 17068990, PMID 18417099, PMID 18458207, PMID 18627623, PMID 19317379, PMID 20175406, PMID 20814317, PMID 21208574, PMID 21208597, PMID 22131611, PMID 23143411, PMID 23514019, PMID 24090266, PMID 24733354, PMID 25323219, PMID 28143413, PMID 28473524, PMID 31238203, PMID 31537089, PMID 31538599, PMID 31992394, PMID 32329435, PMID 32690536, PMID 32918323, PMID 33189083, PMID 33884617, PMID 35022783, PMID 36534165, PMID 38460107, PMID 39119911, PMID 39260076, PMID 41103818, PMID 41462320, PMID 42199304, PMID 42337809
2015 (1), 2023 (1), I01CX002734 (1), R01AG054521 (1), R01MH095776 (1)