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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 3 of 4

COMPLETED NA 100 participants

Behavioral Insomnia Therapy in Primary Care

US Department of Veterans Affairs

NCT00105872

COMPLETED NA 90 participants

Impact of Bed Provision and Sleep Education

Saint Joseph's University, Philadelphia

NCT04536766

COMPLETED Phase 2 83 participants

A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia

Intec Pharma

NCT01277107

COMPLETED Phase 2 80 participants

Valerian to Improve Sleep in Patients With Parkinson's Disease

National Center for Complementary and Integrative Health (NCCIH)

NCT00070928

COMPLETED NA 77 participants

Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care

VA Office of Research and Development

NCT03151083

COMPLETED NA 76 participants

mHealth for Breast Cancer Survivors With Insomnia

Medstar Health Research Institute

NCT05233800

COMPLETED NA 73 participants

Improving Sleep to Reduce Risk for Substance Use Disorder

Florida State University

NCT03226132

COMPLETED NA 73 participants

Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

Baylor College of Medicine

NCT04269239

COMPLETED Phase 2 70 participants

Management of Insomnia in Breast Cancer Patients

Stanford University

NCT01011218

COMPLETED Phase 4 60 participants

Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Lehigh Center for Clinical Research

NCT00813735

COMPLETED NA 56 participants

Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)

Dana-Farber Cancer Institute

NCT05358951

COMPLETED NA 56 participants

Insomnia Treatment and Problems (the iTAP Study)

University of Missouri-Columbia

NCT03627832

COMPLETED NA 56 participants

CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors

Dana-Farber Cancer Institute

NCT02756390

COMPLETED Phase 1 56 participants

Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults

Takeda

NCT00914862

COMPLETED NA 55 participants

Making Better Lives: Patient-Focused Care for Low Back Pain (LBP)

VA Office of Research and Development

NCT02697435

COMPLETED NA 54 participants

Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)

VA Office of Research and Development

NCT02248675

COMPLETED NA 54 participants

Cognitive Behavioral Therapy for Insomnia in People With Chronic Obstructive Pulmonary Disease(COPD)

University of Illinois at Chicago

NCT01072292

COMPLETED NA 50 participants

A Computerized CBTi for Insomnia in Epilepsy

The Cleveland Clinic

NCT03632889

COMPLETED NA 50 participants

Predictors of Response to Insomnia Treatments for Gulf War Veterans

VA Office of Research and Development

NCT03208049

COMPLETED NA 49 participants

An Efficient Treatment for Posttraumatic Injury for Firefighters

Palo Alto Veterans Institute for Research

NCT05950035

COMPLETED NA 48 participants

Cognitive Training in Mild Cognitive Impairment

University of Missouri-Columbia

NCT04899089

COMPLETED NA 48 participants

Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

University of Rochester

NCT01683799

COMPLETED NA 45 participants

Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer

University of Michigan

NCT02495155

COMPLETED Phase 4 44 participants

The Treatment of Insomnia in Patients With HIV Disease

Duke University

NCT00465972

COMPLETED 44 participants

Challenging the Inflammatory Response System in Insomnia Disorder

Beth Israel Deaconess Medical Center

NCT02261597

COMPLETED NA 41 participants

Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia

Dreem

NCT05438017

COMPLETED NA 33 participants

The Yoga and Insomnia Study

University of Pittsburgh

NCT05723211

COMPLETED NA 33 participants

Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors

Ohio State University Comprehensive Cancer Center

NCT01929720

COMPLETED NA 31 participants

Efficacy of Behavioral Insomnia Treatment for Chronic Migraine

Daniel Riche

NCT01314651

COMPLETED NA 30 participants

Insomnia and Osteoarthritis Study

Johns Hopkins University

NCT00374556

COMPLETED NA 30 participants

Mindfulness Based Therapy for Insomnia in Black Women

Yale University

NCT04951466

COMPLETED NA 30 participants

Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions

Roxane Laboratories

NCT00602719

COMPLETED NA 30 participants

Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors

University of Michigan Rogel Cancer Center

NCT04827459

COMPLETED Phase 1 28 participants

Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients

National Institute of Nursing Research (NINR)

NCT00133601

COMPLETED Phase 2 28 participants

Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric Comorbidity

Janssen Research & Development

NCT02464046

COMPLETED NA 24 participants

Sleep Chatbot Intervention for Emerging Black/African American Adults

University of Delaware

NCT05956886

COMPLETED NA 23 participants

Augmenting Benzodiazepine Receptor Agonist Deprescribing With Acupuncture and Yoga Among Older Adults

Vanderbilt University Medical Center

NCT06197243

COMPLETED NA 22 participants

Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study

Durham VA Medical Center

NCT00734799

COMPLETED NA 22 participants

Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors

Dana-Farber Cancer Institute

NCT03279055

COMPLETED Phase 4 21 participants

A Pilot Study of Suvorexant for Insomnia in Parkinson Disease

Burdick, Daniel, M.D.

NCT02729714

COMPLETED NA 20 participants

Bioboosti Device for Insomnia Treatment

Brigham and Women's Hospital

NCT02924116

COMPLETED NA 20 participants

Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms

Courtney Millar

NCT06786494

COMPLETED NA 20 participants

Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)

University of Alabama at Birmingham

NCT06006299

COMPLETED NA 20 participants

Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

Indiana University

NCT03390114

COMPLETED NA 13 participants

Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers

Memorial Sloan Kettering Cancer Center

NCT03012425

COMPLETED NA 13 participants

Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy

University of Tul

NCT03831412

COMPLETED NA 12 participants

Use of an Internet-Based Insomnia Intervention to Prevent Cognitive Decline in Adults With Mild Cognitive Impairment

University of Virginia

NCT04382365

COMPLETED Phase 4 12 participants

Eszopiclone Treatment & Cortisol Responsivity

Butler Hospital

NCT00889200

COMPLETED NA 10 participants

The Effect of White Noise In High Noise Environment

Weill Medical College of Cornell University

NCT02647138

COMPLETED NA 8 participants

Researching Effective Sleep Treatments (Project REST)

University of California, San Diego

NCT02120989

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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.