129 completed. 129 Phase 3, 14 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 129 | Completed 129 |
| Phase 2 | 14 | Completed 14 |
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 |
|---|---|---|---|---|---|---|
| Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder YZJ-1139, Zolpidem - Insomnia Disorder | Phase 3 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 61 | 2025-03-25 | 2026-06-29 |
| 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 |
| A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder Daridorexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Nxera Pharma Korea Co., Ltd. | 164 | 2024-12-04 | 2026-01-21 |
| A Study of Daridorexant in Chinese Patients With Insomnia Disorder Daridorexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Jiangsu Simcere Pharmaceutical Co., Ltd. | 206 | 2023-08-28 | 2024-10-30 |
| Acceptance Commitment Therapy for Caregivers of People with Memory Loss Acceptance and Commitment Therapy - Caregiver Burden, Behavioral and Psychiatric Symptoms of Dementia | Phase 3 | Completed | Utah State University | 121 | 2023-02-16 | 2024-12-06 |
| 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 |
| Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder YZJ-1139 20mg, YZJ-1139 40mg, Placebo - Insomnia Disorder | Phase 3 | Completed | Shanghai Haiyan Pharmaceutical Technology Co., Ltd. | 1037 | 2021-12-17 | 2026-06-30 |
| 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 of Lemborexant in Chinese Participants With Insomnia Disorder Lemborexant, Placebo - Sleep Initiation and Maintenance Disorders | Phase 3 | Completed | Eisai Co., Ltd. | 194 | 2020-11-06 | 2024-12-20 |
| 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 |
| Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg - Insomnia Disorder | Phase 3 | Completed | Idorsia Pharmaceuticals Ltd. | 804 | 2018-10-09 | 2022-03-02 |
| 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 |
| Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder Daridorexant 25 mg, Daridorexant 50 mg, Placebo - Insomnia Disorder | Phase 3 | Completed | Idorsia Pharmaceuticals Ltd. | 930 | 2018-06-04 | 2022-03-25 |
| Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep Daridorexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Idorsia Pharmaceuticals Ltd. | 924 | 2018-05-29 | 2022-03-25 |
| SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia. SM-1, D+Z, D+L - Transient Insomnia | Phase 3 | Completed | Sequential Medicine Ltd | 85 | 2017-10-09 | 2019-06-05 |
| To Decrease Fatigue With Light Therapy Light therapy intensity 1, Light therapy intensity 2 - Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma | Phase 3 | Completed | The Netherlands Cancer Institute | 166 | 2017-09-20 | 2020-09-01 |
| Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2) lemborexant, Placebo - Insomnia Disorder | Phase 3 | Completed | Eisai Inc. | 971 | 2016-11-15 | 2020-02-06 |
| 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 |
| Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061) Suvorexant, Placebo - Sleep Initiation and Maintenance Disorders, Alzheimer Disease | Phase 3 | Completed | Merck Sharp & Dohme LLC | 285 | 2016-05-23 | 2019-10-16 |
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Sleep Wake Disorders (11) · Depressive Disorder, Major (6) · Depression (5) · Parasomnias (5) · Alzheimer Disease (4) · Anxiety Disorders (4) · Dyssomnias (4) · Mental Disorders (4) · Sleep Disorders, Intrinsic (4) · Attention Deficit Disorder with Hyperactivity (3) · Fatigue (3) · Stress Disorders, Traumatic (3) · Substance-Related Disorders (3) · Behavior (2)
Nervous System Diseases (128) · Dyssomnias (125) · Mental Disorders (125) · Sleep Disorders, Intrinsic (125) · Sleep Wake Disorders (118) · Pathological Conditions, Signs and Symptoms (19) · Signs and Symptoms (17) · Neurologic Manifestations (13) · Brain Diseases (8) · Central Nervous System Diseases (8) · Mood Disorders (8) · Behavior (7) · Behavioral Symptoms (6) · Depressive Disorder (6) · Neurodegenerative Diseases (6)
Eszopiclone (15) · Zolpidem (13) · ramelteon (11) · gaboxadol (10) · Gabapentin (9) · Cognitive Behavioral Therapy (7) · Mirtazapine (5) · SR 46349B (5) · daridorexant (5) · Trazodone (4) · lemborexant (4) · suvorexant (4) · Melatonin (3) · zopiclone (3) · Return to Work (2)
H. Lundbeck A/S (10) · Sanofi (10) · Takeda (10) · Merck Sharp & Dohme LLC (9) · Sumitomo Pharma America, Inc. (9) · Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (8) · Karolinska Institutet (4) · Astellas Pharma Inc (3) · Eisai Co., Ltd. (3) · Eisai Inc. (3) · Idorsia Pharmaceuticals Ltd. (3) · Boehringer Ingelheim (2) · Brasilia University Hospital (2) · Kuhnil Pharmaceutical Co., Ltd. (2) · Shanghai Haiyan Pharmaceutical Technology Co., Ltd. (2)
United States (63) · Canada (15) · France (13) · Germany (12) · United Kingdom (10) · Netherlands (9) · Sweden (9) · Australia (8) · Finland (8) · Spain (8) · Czechia (7) · China (6) · Denmark (6) · Italy (6) · Japan (6)
Atsushi Kamijo (2) · Doo-Heum Park, M.D., Ph.D. (2) · Jaap Lancee, PhD (2) · Seung-Chul Hong, M.D., Ph.D. (2) · Thomas Roth, PhD (2)
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