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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
Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Kaiser Permanente
NCT06067139
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
VA Office of Research and Development
NCT03642028
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
University of Virginia
NCT05565833
Optimizing Sleep Health in Nurses
Oregon State University
NCT05965609
Mindfulness Meditation for Insomnia
Brigham and Women's Hospital
NCT06972303
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
Eisai
NCT06744673
Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
Jonsson Comprehensive Cancer Center
NCT00690196
Efficacy of Ramelteon in Subjects With Chronic Insomnia
Takeda
NCT00671086
Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus
Sanofi
NCT00495885
Efficacy Study of LY2422347 to Treat Insomnia
Eli Lilly and Company
NCT00259311
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
GlaxoSmithKline
NCT00280423
Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness
University of Virginia
NCT03213132
Insomnia Self-Management in Heart Failure
Yale University
NCT02660385
Efficacy Study of EVT 201 in the Treatment of Elderly Patients With Daytime Sleepiness
Evotec Neurosciences
NCT00401284
Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia
Duke University
NCT00321451
Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers
University of Virginia
NCT04986904
Remote Study of NightWare for PTSD With Nightmares
NightWare
NCT03934658
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
Stanford University
NCT00383643
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
University of Pittsburgh
NCT00167375
Cognitive Behavioral Therapy for Trauma-Related Insomnia in Veterans
Southeast Louisiana Veterans Health Care System
NCT01176123
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 1 |
| Phase 2 | 6 |
| Phase 3 | 2 |
| Phase 4 | 1 |
Top Sponsors
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.
Read our methodology — how this data is sourced, computed, and verified.
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.