120 completed, 19 recruiting, 9 not yet recruiting, 8 terminated. 170 Phase 2, 18 Phase 3, 17 Phase 1.
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 |
|---|---|---|---|---|---|---|
| Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation Lemborexant 5 mg, Placabo - Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 128 | 2026-11-01 | 2026-10-29 |
| Lemborexant on Perioperative Sleep Quality in Patients With Brain Tumor Undergoing Surgery Lemborexant 5 mg, placebo - Brain Neoplasms, Sleep Initiation and Maintenance Disorders | Phase 2 | Not yet recruiting | Beijing Tiantan Hospital | 112 | 2026-11-01 | 2026-10-29 |
| A Trial of ALN-6457 in Adult Participants With Symptomatic Prion Disease (PrD) ALN-6457 - Prion Disease | Phase 1 / Phase 2 | Not yet recruiting | Regeneron Pharmaceuticals | 60 | 2026-10-23 | 2026-09-22 |
| 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 |
| Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer Tiaoshen Anti-cancer Granules, Placebo Granules, Cognitive Behavioral Therapy for Insomnia - Ovarian Neoplasms Malignant, Sleep Initiation and Maintenance Disorders | Phase 2 / Phase 3 | Not yet recruiting | Shanghai Municipal Hospital of Traditional Chinese Medicine | 360 | 2026-05-01 | 2026-04-24 |
| 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 |
| The Effect of CBD on Sleep Quality Following Late Evening Exercise Cannabidiol or placebo, late evening exercise - Sleep Quality | Phase 2 | Recruiting | KU Leuven | 20 | 2026-03-19 | 2026-05-06 |
| 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 |
| Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study) Trazodone 25 mg - Insomnia Chronic, Older People | Phase 2 | Recruiting | Centre hospitalier de l'Université de Montréal (CHUM) | 40 | 2025-11-10 | 2025-12-08 |
| A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances RE03, Placebo - Posttraumatic Stress Disorder (PTSD), Sleep Disturbances and Insomnia | Phase 2 | Completed | Reconnect Labs | 12 | 2025-09-30 | 2026-07-23 |
| Chinese Medicine in Treating Insomnia Modified Suan ZaoRen Tang-TianWang BuXin Dan, Placebo - Insomnia Chronic | Phase 2 | Recruiting | Chinese University of Hong Kong | 76 | 2025-09-25 | 2026-07-27 |
| 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 |
| Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients Lemborexant 5 mg, Control (placebo) group - Delirium - Postoperative, Cardiac Surgery | Phase 2 | Not yet recruiting | University of British Columbia | 60 | 2025-05-01 | 2025-04-23 |
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Anxiety Disorders (12) · Depression (12) · Sleep Wake Disorders (11) · Stress Disorders, Post-Traumatic (8) · Pain (6) · Parasomnias (6) · Fatigue (5) · Alzheimer Disease (4) · Cognitive Dysfunction (4) · Dementia (4) · Depressive Disorder, Major (4) · Insomnia, Fatal Familial (4) · Multiple Sclerosis (4) · Sleep Deprivation (4)
Dyssomnias (168) · Nervous System Diseases (168) · Mental Disorders (167) · Sleep Disorders, Intrinsic (166) · Sleep Wake Disorders (159) · Pathological Conditions, Signs and Symptoms (40) · Signs and Symptoms (32) · Neurologic Manifestations (25) · Behavior (17) · Central Nervous System Diseases (15) · Brain Diseases (14) · Behavioral Symptoms (13) · Chemically-Induced Disorders (11) · Neurocognitive Disorders (10) · Neurodegenerative Diseases (10)
Cognitive Behavioral Therapy (12) · Zolpidem (12) · Melatonin (7) · lemborexant (7) · ramelteon (7) · suvorexant (7) · Sugars (5) · casopitant (4) · daridorexant (4) · (1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid (3) · Cannabidiol (3) · Gabapentin (3) · Probiotics (3) · Desensitization, Psychologic (2) · Dexmedetomidine (2)
GlaxoSmithKline (7) · Takeda (6) · Stanford University (5) · Idorsia Pharmaceuticals Ltd. (4) · University of Utah (4) · Brigham and Women's Hospital (3) · Duke University (3) · Johns Hopkins University (3) · Neurim Pharmaceuticals Ltd. (3) · Pfizer (3) · University of Virginia (3) · Woolcock Institute of Medical Research (3) · Arena Pharmaceuticals (2) · Beijing Tiantan Hospital (2) · Eisai Co., Ltd. (2)
United States (103) · Germany (11) · Canada (10) · China (6) · Australia (5) · France (3) · Ireland (3) · Japan (3) · Switzerland (3) · Belgium (2) · Brazil (2) · Denmark (2) · Israel (2) · Netherlands (2) · Poland (2)
Brendon Yee, MBChB, FRACP, FCCP, PhD (2) · Camilla Hoyos, MPH, PhD (2) · Eileen Murphy, PhD (2) · Gavin West, M.D. (2) · James K Walsh, PhD (2) · James K. Walsh, PhD (2) · Abby C King, PhD (1) · Alexandra Kearson, BA (1)
PMID 41170811, PMID 10341379, PMID 11918106, PMID 14733976, PMID 17109795, PMID 17294232, PMID 17352947, PMID 17520797, PMID 17671050, PMID 17690599, PMID 18457236, PMID 18482867, PMID 18555170, PMID 18840807, PMID 19186083, PMID 19398354, PMID 19491110, PMID 19581560, PMID 20435443, PMID 20620105, PMID 21397868, PMID 21643649, PMID 21939549, PMID 22348451, PMID 23063301, PMID 23197752, PMID 23286463, PMID 24122181, PMID 25142566, PMID 25452447, PMID 25917009, PMID 26979830, PMID 27788313, PMID 28777364, PMID 28782982, PMID 29065953, PMID 29504795, PMID 29848147, PMID 30621831, PMID 30929703, PMID 30952216, PMID 31953863, PMID 32341187, PMID 32434498, PMID 32511726, PMID 33057694, PMID 33131027, PMID 33189083, PMID 33283264, PMID 33928908
2004 (1), 2015 (1), 2017 (1), 2023 (1), 2025 (1), IK2CX002363-01A1 (1), K07CA132916 (1), K23AT003678 (1), K23AT012475 (1), P01AG021601 (1), P30AG063786 (1), R01AR052368 (1), R01AT001521 (1), R01AT002490 (1), R01AT013240 (1)