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ClinicalTrials.gov 5 recruiting now official registry

Sleep Initiation and Maintenance Disorders clinical trials

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

20 US clinical trials · 5 currently recruiting

The research picture

Sleep Initiation and Maintenance Disorders has 20 registered US clinical trials, 5 of them open to new participants right now — about 25% of the total.

5
recruiting participants now
25%
of trials open to enrollment
3
in Phase 3–4 (later-stage)
3
top sponsor: University of Virginia

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 300 participants

Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

Kaiser Permanente

NCT06067139

RECRUITING Phase 4 190 participants

Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

VA Office of Research and Development

NCT03642028

RECRUITING Phase 2 144 participants

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

University of Virginia

NCT05565833

RECRUITING NA 60 participants

Optimizing Sleep Health in Nurses

Oregon State University

NCT05965609

RECRUITING Phase 1 30 participants

Mindfulness Meditation for Insomnia

Brigham and Women's Hospital

NCT06972303

ACTIVE NOT RECRUITING 861 participants

A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population

Eisai

NCT06744673

ACTIVE NOT RECRUITING NA 90 participants

Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms

Jonsson Comprehensive Cancer Center

NCT00690196

COMPLETED Phase 3 1,213 participants

Efficacy of Ramelteon in Subjects With Chronic Insomnia

Takeda

NCT00671086

COMPLETED Phase 3 848 participants

Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus

Sanofi

NCT00495885

COMPLETED Phase 2 400 participants

Efficacy Study of LY2422347 to Treat Insomnia

Eli Lilly and Company

NCT00259311

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 311 participants

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

University of Virginia

NCT03213132

COMPLETED NA 195 participants

Insomnia Self-Management in Heart Failure

Yale University

NCT02660385

COMPLETED Phase 2 135 participants

Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness

Evotec Neurosciences

NCT00401284

COMPLETED Phase 2 111 participants

Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

Duke University

NCT00321451

COMPLETED NA 102 participants

Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

University of Virginia

NCT04986904

COMPLETED NA 81 participants

Remote Study of NightWare for PTSD With Nightmares

NightWare

NCT03934658

COMPLETED Phase 2 48 participants

Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.

Stanford University

NCT00383643

COMPLETED 24 participants

Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

University of Pittsburgh

NCT00167375

COMPLETED NA 24 participants

Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans

Southeast Louisiana Veterans Health Care System

NCT01176123

Phase Distribution

PhaseTrial count
Phase 1 1
Phase 2 6
Phase 3 2
Phase 4 1

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

Reading the Sleep Initiation and Maintenance Disorders Trial Landscape

ClinicalTrials.gov lists 20 US studies indexed under Sleep Initiation and Maintenance Disorders, and 5 of those are currently open to recruitment — roughly 25% 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 Sleep Initiation and Maintenance Disorders shows 3 late-stage studies (Phase 3 and Phase 4 combined) alongside 7 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 Sleep Initiation and Maintenance Disorders is led by University of Virginia with 3 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 20 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 Sleep Initiation and Maintenance Disorders?

PlainTrial tracks 20 US clinical trials for Sleep Initiation and Maintenance Disorders, of which 5 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Sleep Initiation and Maintenance Disorders?

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.

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