Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

ClinicalTrials.gov 62 recruiting now official registry

Insomnia clinical trials

Every US clinical trial registered for Insomnia — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

152 US clinical trials · 62 currently recruiting

The research picture

Insomnia has 152 registered US clinical trials, 62 of them open to new participants right now — about 41% of the total.

62
recruiting participants now
41%
of trials open to enrollment
17
in Phase 3–4 (later-stage)
9
top sponsor: VA Office of Research and Development

Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.

Active & Recent Trials

RECRUITING NA 1,500 participants

Digital CBT for Insomnia and Depression

University of Rochester

NCT05456607

RECRUITING Phase 4 1,000 participants

Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms

Brigham and Women's Hospital

NCT07136415

RECRUITING 785 participants

Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

Idorsia Pharmaceuticals

NCT06498128

RECRUITING NA 600 participants

Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

Henry Ford Health System

NCT05182372

RECRUITING Early Phase 1 600 participants

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Milton S. Hershey Medical Center

NCT06281756

RECRUITING Phase 2 500 participants

Sleep to Reduce Incident Depression Effectively in Peripartum

Henry Ford Health System

NCT06430333

RECRUITING Phase 4 430 participants

Enhancing Hypnotic Medication Discontinuation in Primary Care

National Jewish Health

NCT06435520

RECRUITING NA 400 participants

Treatments for Insomnia in Veterans With PTSD

VA Office of Research and Development

NCT05194930

RECRUITING NA 360 participants

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Johns Hopkins University

NCT05663034

RECRUITING NA 350 participants

A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care

Brigham and Women's Hospital

NCT05759065

RECRUITING NA 340 participants

Project Women's Insomnia Sleep Health Equity Study (WISHES)

Yale University

NCT06348082

RECRUITING Phase 3 300 participants

A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)

Merck Sharp & Dohme

NCT06655883

RECRUITING Phase 2 300 participants

Resilience Enhancement Following Sleep Treatment

University of Virginia

NCT07298941

RECRUITING NA 288 participants

Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis

University of Michigan

NCT06580561

RECRUITING NA 256 participants

Sleep as a Mechanism of Change in Alcohol Use

University of Missouri-Columbia

NCT06286774

RECRUITING NA 250 participants

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

Johns Hopkins University

NCT05780814

RECRUITING NA 235 participants

Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior

Jeff Bridge

NCT05390918

RECRUITING NA 200 participants

Targeting Insomnia to Improve Outcomes in Adults With Problematic Cannabis Use

University of Michigan

NCT05814822

RECRUITING NA 200 participants

Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain

Washington University School of Medicine

NCT07270406

RECRUITING NA 192 participants

Multi-center Trial to Improve Nocturia and Sleep in Older Adults

Atlanta VA Medical Center

NCT06110091

RECRUITING NA 176 participants

mPATH for Low-income Older Adults

Johns Hopkins University

NCT05935241

RECRUITING NA 168 participants

Behavioral Treatment of Insomnia in Active-Duty Service Members With Traumatic Brain Injury

Noctem

NCT06867666

RECRUITING NA 167 participants

Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder

University of California, Los Angeles

NCT05516277

RECRUITING NA 160 participants

Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD

Palo Alto Veterans Institute for Research

NCT07069517

RECRUITING NA 160 participants

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

The University of Texas Health Science Center at San Antonio

NCT06551987

RECRUITING NA 150 participants

Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery

Johns Hopkins University

NCT05935735

RECRUITING NA 150 participants

Sleep Mechanisms Of Regulating Emotions

Stanford University

NCT06373718

RECRUITING Phase 2 144 participants

Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

University of Virginia

NCT05565833

RECRUITING NA 144 participants

Effectiveness of Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep - Clinical Trial

University of Arizona

NCT06631209

RECRUITING NA 115 participants

Training in Evidence-based Treatments in Psycho-Oncology

Massachusetts General Hospital

NCT05674357

RECRUITING Phase 2 114 participants

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

Yale University

NCT06609369

RECRUITING NA 100 participants

Treatments in Women Veterans With Insomnia and PTSD

VA Office of Research and Development

NCT05683132

RECRUITING NA 100 participants

Sleep Treatment Education Program for Cancer Survivors: STEP-Together

Dana-Farber Cancer Institute

NCT06736548

RECRUITING NA 100 participants

Wearable Transcranial Electrical Stimulation (tES) for Insomnia

Uniformed Services University of the Health Sciences

NCT06100185

RECRUITING NA 100 participants

NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers

University of South Florida

NCT04896775

RECRUITING Phase 2 100 participants

Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects

Virginia Commonwealth University

NCT06981195

RECRUITING Phase 2 90 participants

Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

University of Kansas Medical Center

NCT06434571

RECRUITING NA 90 participants

The Effect of Sleep Loss on Emotion Regulation

Beth Israel Deaconess Medical Center

NCT05393830

RECRUITING NA 83 participants

RISE: A Remote Study of Insomnia Treatment in Crohn's Disease

Dartmouth-Hitchcock Medical Center

NCT05956158

RECRUITING NA 80 participants

Restorative Early Sleep Treatment After the Emergency Department

Henry Ford Health System

NCT07121270

RECRUITING NA 80 participants

University of Colorado - Restoring Efficient Sleep After TBI

VA Eastern Colorado Health Care System

NCT05683145

RECRUITING NA 80 participants

Innovating CBT-I for Cancer Survivors: An Optimization Trial

Massachusetts General Hospital

NCT06181643

RECRUITING NA 80 participants

CF Wellness Program

Johns Hopkins University

NCT07071324

RECRUITING Phase 2 76 participants

Suvorexant for Treatment of AUD and PTSD

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

NCT06679062

RECRUITING Phase 2 70 participants

Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis

University of Kansas Medical Center

NCT06428006

RECRUITING NA 70 participants

Adapting CBT-I for Hazardous Alcohol Users

University of Rochester

NCT05973955

RECRUITING Phase 4 61 participants

Efficacy of Suvorexant in the Treatment of Insomnia in Midlife Women With Pre-Diabetes

Brigham and Women's Hospital

NCT05593653

RECRUITING Phase 2 60 participants

Pimavanserin for Insomnia in Veterans With PTSD

VA Office of Research and Development

NCT05441280

RECRUITING NA 60 participants

Noradrenergic Dysregulation, Sleep and Cognition in Older Adults with Insomnia

Northwestern University

NCT06694441

RECRUITING NA 55 participants

The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers

Rhode Island Hospital

NCT06737055

RECRUITING NA 50 participants

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Massachusetts General Hospital

NCT06375265

RECRUITING NA 40 participants

Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia

St. Jude Children's Research Hospital

NCT07191119

RECRUITING NA 40 participants

Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr

University of South Florida

NCT07091149

RECRUITING NA 40 participants

Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors

Georgetown University

NCT07128927

RECRUITING 40 participants

Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep

University of Kansas Medical Center

NCT06840444

RECRUITING Phase 1 30 participants

Mindfulness Meditation for Insomnia

Brigham and Women's Hospital

NCT06972303

RECRUITING NA 30 participants

Treating Insomnia in Mild Cognitive Impairment

Beth Israel Deaconess Medical Center

NCT06687161

RECRUITING NA 28 participants

Adapted CBT-I for Adolescents With Insomnia : The DREAM-IT Study

Indiana University

NCT06541886

RECRUITING NA 25 participants

Forehead Temperature-Regulating Therapy for Insomnia in Adults With Tourette's Disorder

University of California, Los Angeles

NCT05499741

RECRUITING NA 15 participants

Novel Adaptive Cognitive Training in Autistic Adults with Co-occurring Insomnia

University of South Florida

NCT06291298

RECRUITING Early Phase 1 15 participants

CBTi for the Treatment of Insomnia in Type 1 Diabetes

University of Illinois at Chicago

NCT07091318

RECRUITING NA 10 participants

LiverSleep: A Behavioral Sleep Intervention for Patients With Cirrhosis and Insomnia

Massachusetts General Hospital

NCT07417163

ACTIVE NOT RECRUITING NA 1,000 participants

The Assessment of Human Sleep and Its Functions

StimScience

NCT07211646

ACTIVE NOT RECRUITING Phase 3 673 participants

National Adaptive Trial for PTSD Related Insomnia

VA Office of Research and Development

NCT03668041

ACTIVE NOT RECRUITING NA 456 participants

Perinatal Research on Improving Sleep and Mental Health

University of California, San Francis

NCT05596318

ACTIVE NOT RECRUITING NA 240 participants

Remote STATE Training for Insomnia in Older Adults

Posit Science Corporation

NCT06589024

ACTIVE NOT RECRUITING NA 224 participants

Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial

Seattle Children's Hospital

NCT04936321

ACTIVE NOT RECRUITING Phase 4 200 participants

Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

ProofPilot

NCT04627480

ACTIVE NOT RECRUITING NA 152 participants

CBT-I to Improve Functional Outcomes in Veterans With Psychosis

VA Office of Research and Development

NCT04646200

ACTIVE NOT RECRUITING NA 134 participants

Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)

University of Michigan

NCT04457674

ACTIVE NOT RECRUITING NA 100 participants

Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

Henry Ford Health System

NCT05356364

ACTIVE NOT RECRUITING Phase 2 98 participants

Effects of Mirtazapine on Appetite in Advanced Cancer Patients

M.D. Anderson Cancer Center

NCT00488072

ACTIVE NOT RECRUITING NA 80 participants

Neurotechnology Following Traumatic Brain Injury

Brain State Technologies

NCT03649958

ACTIVE NOT RECRUITING Phase 4 60 participants

Solriamfetol and CBT-I in Patients With Insomnia Disorder

University of Pennsylvania

NCT05838430

ACTIVE NOT RECRUITING NA 60 participants

A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors

University of Washington

NCT06392789

ACTIVE NOT RECRUITING NA 60 participants

Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

Brigham and Women's Hospital

NCT05991492

ACTIVE NOT RECRUITING 50 participants

Partial Sleep Restriction in Chronic Low Back Pain: A Feasibility Study

University of Kansas Medical Center

NCT07008924

ACTIVE NOT RECRUITING NA 42 participants

Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

University of Rochester

NCT04458194

ACTIVE NOT RECRUITING NA 14 participants

Nexalin Therapy as a Viable Adjunctive Treatment for Substance Use Disorders

University of Arizona

NCT03540745

COMPLETED NA 1,836 participants

Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study

Stanford University

NCT02037438

COMPLETED NA 746 participants

Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors

University of Rochester NCORP Research Base

NCT02613364

COMPLETED Phase 3 545 participants

A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder

Sumitomo Pharma America

NCT00368030

COMPLETED NA 542 participants

Hypertension With Unsatisfactory Sleep Health

University of Pittsburgh

NCT02508129

COMPLETED Phase 4 420 participants

Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

Sumitomo Pharma America

NCT00235508

COMPLETED Phase 2 342 participants

Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

GlaxoSmithKline

NCT00280423

COMPLETED NA 333 participants

Reducing Health Disparities for Black Women in the Treatment of Insomnia

Boston University

NCT03613519

COMPLETED NA 311 participants

Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness

University of Virginia

NCT03213132

COMPLETED Phase 3 304 participants

Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia

Sumitomo Pharma America

NCT00857220

COMPLETED 250 participants

Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire

Dayzz Live Well

NCT03468400

COMPLETED NA 208 participants

Research on Expecting Moms and Sleep Therapy

University of California, San Francis

NCT02805998

COMPLETED Phase 4 197 participants

Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia

University of Pennsylvania

NCT03774810

COMPLETED NA 180 participants

Impact of Sleep Workshops in College Students

NYU Langone Health

NCT02665247

COMPLETED Phase 2 173 participants

Safety and Efficacy Study of APD125 in Patient With Insomnia

Arena Pharmaceuticals

NCT00452179

COMPLETED NA 167 participants

Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

Henry Ford Health System

NCT05523726

COMPLETED NA 160 participants

Choosing Options for Insomnia in Cancer Effectively (CHOICE): A Comparative Effectiveness Trial of Acupuncture and Cognitive Behavior Therapy

Memorial Sloan Kettering Cancer Center

NCT02356575

COMPLETED NA 128 participants

Treatments for Insomnia: Mediators, Moderators and Quality of Life

Palo Alto Veterans Institute for Research

NCT02117388

COMPLETED Phase 3 126 participants

Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis

University of Washington

NCT03534284

COMPLETED NA 114 participants

Dual Treatment of Chronic Pain and Insomnia

Mary Free Bed Rehabilitation Hospital

NCT05033418

COMPLETED Phase 4 108 participants

Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

Massachusetts General Hospital

NCT03818581

COMPLETED NA 102 participants

Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

University of Virginia

NCT04986904

Phase Distribution

PhaseTrial count
Phase 1 5
Phase 2 16
Phase 3 5
Phase 4 12

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Insomnia Trial Landscape

ClinicalTrials.gov lists 152 US studies indexed under Insomnia, and 62 of those are currently open to recruitment — roughly 41% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Insomnia shows 17 late-stage studies (Phase 3 and Phase 4 combined) alongside 21 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Insomnia is led by VA Office of Research and Development with 9 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 100 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Insomnia?

PlainTrial tracks 152 US clinical trials for Insomnia, of which 62 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Insomnia?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →