Data updated: Jun 28, 2026
Insomnia Clinical Trial Landscape
Insomnia is being studied across 265 clinical trials registered since 2008, with 58 programs currently active. The competitive pipeline includes 10 active Phase 3 trials, 26 active Phase 2 trials, and 5 active Phase 1 trials.
Trial activity
58 active / 265 total since 2008
Active by phase 10 Ph3 / 65 26 Ph2 / 90 5 Ph1 / 39 17 Ph4 / 71
Sponsor activity
Who is running trials now — green active, blue completed, red failed/terminated.
Sorted by active Active Done Failed
Shanghai Haiyan Pharmaceutical Technology Co., Ltd. 4 4 0
Merck 1 12 0
Sequential Medicine Ltd 1 2 1
Vanda Pharmaceuticals 1 1 0
RDC Clinical Pty Ltd 1 0 0
Apsen Farmaceutica S.A. 1 0 0
Proactive Life Inc 1 0 0
Reconnect Labs 1 0 0
Avecho Biotechnology 1 0 0
Nyree Penn 1 0 0
Afasci Inc 1 0 0
Nanjing Chia-tai Tianqing Pharmaceutical 1 0 0
ProofPilot 1 0 0
Jiangsu Hansoh Pharmaceutical Co., Ltd. 1 0 0
Idorsia Pharmaceuticals Ltd. 0 8 0
How the field has grown
New-trial starts peaked in 2023 (21 registered); 2025 saw 20. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (32 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.
New trials started by year
2016 16
2017 11
2018 10
2019 13
2020 13
2021 9
2022 14
2023 21
2024 19
2025 20
2026 17
TheraRadar.com
Median Phase 3 enrollment by start year
2016 (4) 696
2017 (2) 203
2018 (5) 804
2019 (3) 87
2020 (1) 184
2021 (1) 673
2022 (4) 238
2023 (2) 231
2024 (4) 250
2025 (5) 300
2026 (1) 732
TheraRadar.com
Full trial pipeline
Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.
NCT06655883 RECRUITING
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
Merck Sharp & Dohme LLC n=300
NCT06619912 RECRUITING
Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients
Xijing Hospital n=686
NCT06975514 RECRUITING
Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder
Shanghai Haiyan Pharmaceutical Technology Co., Ltd. n=60
NCT05840822 RECRUITING
Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia
Avecho Biotechnology n=519
NCT06953869 RECRUITING
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Vanda Pharmaceuticals n=420
NCT06062953 RECRUITING
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Lone Baandrup n=255
NCT06859190 RECRUITING
Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer
Qinghai Red Cross Hospital n=60
NCT04050176 ACTIVE NOT RECRUITING
Use of Blinded Tapering for Hypnotic Discontinuation
National Jewish Health n=260
NCT06512363 NOT YET RECRUITING
A Study of Ramelteon in Chinese Patients With Chronic Insomnia
Nanjing Chia-tai Tianqing Pharmaceutical n=280
NCT07587385 NOT YET RECRUITING
A Study of HS-10506 in Chinese Patients With Insomnia Disorder
Jiangsu Hansoh Pharmaceutical Co., Ltd. n=732
NCT06476392 COMPLETED
Melatonin fOr CHronic bAck Pain (The MOCHA Trial)
Odense University Hospital n=220
NCT03668041 COMPLETED
National Adaptive Trial for PTSD Related Insomnia
VA Office of Research and Development n=673
NCT07028697 COMPLETED
A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder
Nxera Pharma Korea Co., Ltd. n=164
NCT04759703 TERMINATED
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
Massachusetts General Hospital n=75
NCT01549899 COMPLETED
Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
Daniel J. Taylor, Ph.D. n=185
NCT05453136 COMPLETED
Phase III Study of TS-142 in Patients with Insomnia
Taisho Pharmaceutical Co., Ltd. n=1,155
NCT05461352 COMPLETED
Long-Term Study of TS-142 in Patients with Insomnia
Taisho Pharmaceutical Co., Ltd. n=401
NCT02783729 COMPLETED
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
Eisai Inc. n=1,006
NCT06010693 COMPLETED
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
Jiangsu Simcere Pharmaceutical Co., Ltd. n=206
NCT03338764 WITHDRAWN
An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia
Sequential Medicine Ltd
NCT03534284 COMPLETED
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
University of Washington n=126
NCT03771664 TERMINATED
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
Biogen n=87
NCT03373201 COMPLETED
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Vanda Pharmaceuticals n=320
NCT03545191 COMPLETED
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Idorsia Pharmaceuticals Ltd. n=930
NCT03575104 COMPLETED
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Idorsia Pharmaceuticals Ltd. n=924
NCT03679884 COMPLETED
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Idorsia Pharmaceuticals Ltd. n=804
NCT02333149 WITHDRAWN
Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
University of Alberta
NCT03478306 COMPLETED
Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm
Glostrup University Hospital, Copenhagen n=31
NCT04009577 COMPLETED
A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia
Eisai Inc. n=53
NCT00561574 COMPLETED
A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
Merck Sharp & Dohme LLC n=259
NCT03075241 COMPLETED
Z-Drugs for Sleep Disorders in Alzheimer's Disease
Brasilia University Hospital n=62
NCT02952820 COMPLETED
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
Eisai Inc. n=971
NCT01097629 COMPLETED
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)
Merck Sharp & Dohme LLC n=1,020
NCT03331042 COMPLETED
SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.
Sequential Medicine Ltd n=85
NCT00631657 COMPLETED
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
Merck Sharp & Dohme LLC n=460
NCT01097616 COMPLETED
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
Merck Sharp & Dohme LLC n=1,023
NCT01021813 COMPLETED
A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
Merck Sharp & Dohme LLC n=781
NCT02139098 TERMINATED
Alternative Dosing Regimens in the Pharmacotherapy of Insomnia
Philipps University Marburg n=23
NCT00857220 COMPLETED
Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
Sumitomo Pharma America, Inc. n=304
NCT02232256 WITHDRAWN
The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain
9305-9954 Quebec Inc
NCT01438697 COMPLETED
An Interactive Internet Intervention for Adults With Insomnia
University of Virginia n=303
NCT00945412 WITHDRAWN
Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding
Massachusetts Eye and Ear Infirmary
NCT01667822 COMPLETED
Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
Karolinska Institutet n=396
NCT02747979 COMPLETED
The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients
Sun Yat-sen University n=20
NCT00608985 COMPLETED
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Midnight Pharma, LLC n=709
NCT00805350 COMPLETED
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
Sanofi n=637
NCT01667809 COMPLETED
CBT vs RTW Intervention for Patients With Common Subclinical Mental Illness in Primary Care
Karolinska Institutet n=5
NCT01636791 COMPLETED
CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care
Karolinska Institutet n=211
NCT01100164 COMPLETED
A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
Eurofarma Laboratorios S.A. n=263
NCT01545414 COMPLETED
Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease
Karolinska Institutet n=150
NCT01955850 COMPLETED
Online or Face-to-face Treatment for Insomnia?
VU University of Amsterdam n=90
NCT01161108 COMPLETED
Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities
The Hospital for Sick Children n=13
NCT00856973 COMPLETED
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Sumitomo Pharma America, Inc. n=486
NCT00770510 COMPLETED
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Eisai Co., Ltd. n=192
NCT01456637 COMPLETED
Online Self-Help Intervention for Insomnia: With or Without Feedback
Utrecht University n=262
NCT00770692 COMPLETED
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Eisai Co., Ltd. n=369
NCT01142258 COMPLETED
Trazodone for Sleep Disorders in Alzheimer's Disease
Brasilia University Hospital n=40
NCT01468038 COMPLETED
A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food
Targeted Medical Pharma n=111
Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only