81 completed. 81 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 81 | Completed 81 |
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 |
|---|---|---|---|---|---|---|
| EFFECT OF ZOLPIDEM ON SLEEP QUALITY AND OPIOID CONSUMPTION FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL Zolpidem 10 mg tablets, Avocado-soybean unsaponifiables 300 mg - Postoperative Pain Management in Total Knee Arthroplasty | Phase 4 | Completed | Sanatorio Allende | 54 | 2025-08-05 | 2026-09-03 |
| Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality Dexmedetomidine, Esketamine, Normal saline - Old Age, Knee Replacement Surgery | Phase 4 | Completed | Peking University First Hospital | 154 | 2024-01-03 | 2026-07-06 |
| Night-time Dexmedetomidine-esketamine Infusion and Sleep Quality in ICU Patients Dexmedetomidine-esketamine, Routine sedation and analgesia - Intensive Care Unit, Mechanical Ventilation | Phase 4 | Completed | Peking University First Hospital | 174 | 2023-11-01 | 2025-12-05 |
| 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 |
| Dexmedetomidine-esketamine Combined Nasal Administration and Perioperative Sleep Quality Dexmedetomidine, Esketamine, Normal saline - Breast Cancer, Perioperative Period | Phase 4 | Completed | Peking University First Hospital | 180 | 2023-05-22 | 2025-07-31 |
| Efficacy of Suvorexant on Post-operative Sleep Disturbance Suvorexant, Placebo - Postoperative Insomnia, Postoperative Delirium | Phase 4 | Completed | Columbia University | 100 | 2023-05-01 | 2026-07-23 |
| A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia Daridorexant, Placebo - Insomnia Disorder, Nocturia | Phase 4 | Completed | Idorsia Pharmaceuticals Ltd. | 60 | 2023-02-16 | 2025-04-18 |
| 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 |
| Melatonin and DNA Damage Study Melatonin, Placebo - Sleep Quality, DNA Damage Repair Deficiency | Phase 4 | Completed | University of British Columbia | 40 | 2022-06-01 | 2024-08-28 |
| CBT-I or Zolpidem/Trazodone for Insomnia Zolpidem, Internet Cognitive Behavioral Therapy for Insomnia (CBT-I), Trazodone - Chronic Insomnia | Phase 4 | Completed | California Pacific Medical Center Research Institute | 155 | 2022-02-25 | 2025-02-24 |
| Perceived Changes in Anxiety Symptom Burden During Treatment With Bryophyllum Pinnatum and Tolerability Bryophyllum 50 % Chewing Tablets - Anxiety Symptoms | Phase 4 | Completed | Markus Schlemmer | 51 | 2021-08-31 | 2024-06-21 |
| 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 |
| An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia Lemborexant (LEM) 5 mg (Z-Drug-mono cohort), Lemborexant (LEM) 5 mg (SUV-mono cohort), Lemborexant (LEM) 5 mg (SUV-combination cohort) - Insomnia | Phase 4 | Completed | Kurume University | 97 | 2021-03-24 | 2023-03-15 |
| Dexmedetomidine Supplemented Analgesia in Patients at High-risk of Obstructive Sleep Apnea Dexmedetomidine, Placebo - Obstructive Sleep Apnea, Analgesia | Phase 4 | Completed | Peking University First Hospital | 152 | 2021-01-29 | 2022-12-13 |
| Suvorexant and Sleep/Delirium in ICU Patients Suvorexant 20 mg, Placebo oral tablet - Insomnia, Sleep Fragmentation | Phase 4 | Completed | Beth Israel Deaconess Medical Center | 100 | 2020-02-28 | 2025-10-27 |
| Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder Pimavanserin - Post-traumatic Stress Disorder, Insomnia | Phase 4 | Completed | Baylor College of Medicine | 6 | 2020-01-06 | 2022-08-31 |
| Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP) Suvorexant, Zolpidem, Placebo oral capsule - Progressive Supranuclear Palsy(PSP), Insomnia | Phase 4 | Completed | University of California, San Francisco | 40 | 2019-06-02 | 2026-09-01 |
| Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia Zolpidem tartrate - Insomnia, Insomnia Chronic | Phase 4 | Completed | University of Pennsylvania | 197 | 2019-04-15 | 2025-05-09 |
Showing 20 of 81. Sign in to see all of them.
Sleep Wake Disorders (11) · Depression (7) · Anxiety Disorders (4) · Parasomnias (4) · Depressive Disorder, Major (3) · Fatigue (3) · Hot Flashes (3) · Stress Disorders, Post-Traumatic (3) · Agnosia (2) · Delirium (2) · Emergence Delirium (2) · Pain (2) · Sleep Apnea, Obstructive (2) · Sleep Deprivation (2)
Dyssomnias (81) · Mental Disorders (81) · Nervous System Diseases (81) · Sleep Disorders, Intrinsic (81) · Sleep Wake Disorders (70) · Pathological Conditions, Signs and Symptoms (27) · Signs and Symptoms (26) · Neurologic Manifestations (20) · Behavior (7) · Behavioral Symptoms (7) · Pathologic Processes (6) · Neurobehavioral Manifestations (5) · Central Nervous System Diseases (4) · Mood Disorders (4) · Respiratory Tract Diseases (4)
Zolpidem (20) · Eszopiclone (14) · suvorexant (13) · ramelteon (8) · Dexmedetomidine (6) · Cognitive Behavioral Therapy (4) · Saline Solution (4) · Sugars (3) · Escitalopram (2) · Esketamine (2) · Paroxetine (2) · Temazepam (2) · zopiclone (2) · Analgesia (1) · Apomorphine (1)
Peking University First Hospital (6) · Sanofi (5) · Takeda (5) · Astellas Pharma Inc (4) · Duke University (4) · Brigham and Women's Hospital (2) · China Medical University, China (2) · Henry Ford Health System (2) · Laval University (2) · Massachusetts General Hospital (2) · Sumitomo Pharma America, Inc. (2) · University of Pennsylvania (2) · University of Pittsburgh (2) · University of Rochester (2) · Augusta University (1)
United States (47) · China (8) · Japan (6) · Canada (4) · Brazil (3) · Norway (2) · Taiwan (2) · Argentina (1) · France (1) · Germany (1) · Hungary (1) · Spain (1) · Switzerland (1) · United Kingdom (1)
Dong-Xin Wang, MD, PhD (4) · Phyllis Diener (3) · Andrew D Krystal, MD (2) · Andrew Krystal, MD (2) · Daniel J. Buysse, MD (2) · Dong-Xin Wang, MD,PhD (2) · Balachundhar Subramaniam (1) · Bruno Jolain (1) · Charles M. Morin, PhD (1) · Chris L Drake, PhD (1) · Ciciliana MZ Rech (1) · Claudio N Soares, MD, PhD (1)
PMID 16804151, PMID 17068990, PMID 18417099, PMID 18458207, PMID 18584227, PMID 18627623, PMID 19317379, PMID 19454639, PMID 20175406, PMID 20478741, PMID 20726279, PMID 20814317, PMID 21116652, PMID 21208574, PMID 21208597, PMID 21447050, PMID 21601519, PMID 22131611, PMID 22334811, PMID 23143411, PMID 23563887, PMID 24090266, PMID 24399070, PMID 24882900, PMID 25323219, PMID 26763501, PMID 26963600, PMID 27648659, PMID 27658218, PMID 28364426, PMID 28652381, PMID 29265834, PMID 30871960, PMID 31238203, PMID 31537089, PMID 31538599, PMID 31859791, PMID 32329435, PMID 32690536, PMID 32918323, PMID 33884617, PMID 35022783, PMID 35429481, PMID 36117973, PMID 36534165, PMID 36587547, PMID 36821333, PMID 38460107, PMID 39119911, PMID 39260076
2015 (2), K23MH066978 (1), R01AG054521 (1), R01MH024652 (1), R01MH060413 (1), R01MH095776 (1), R34MH070821 (1), R34MH091338 (1)