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ClinicalTrials.gov 62 recruiting now official registry

Insomnia clinical trials

62 of 152 indexed Insomnia trials are currently recruiting.

152 US clinical trials · 62 currently recruiting

Insomnia is the subject of 152 registered US clinical trials on ClinicalTrials.gov, 62 of them currently open to new participants. 17 are in Phase 3-4 (later-stage) and 21 in Phase 1-2 (earlier-stage). The most active sponsor is VA Office of Research and Development, running 9 of these trials.

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
Phase 15Phase 216Phase 35Phase 412

Active & Recent Trials

152 total, page 1 of 4

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

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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

152 indexed Insomnia studies · 62 recruiting (41%).

Phase mix: 17 late (III/IV) vs 21 early (I/II).

Top sponsor: VA Office of Research and Development (9 trials), 9 others listed. 50 shown below, recruiting first.

How to read this condition's trial landscape

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.

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.

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.

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 →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.