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ClinicalTrials.gov 3 recruiting now official registry

Chronic Insomnia clinical trials

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

12 US clinical trials · 3 currently recruiting

The research picture

Chronic Insomnia has 12 registered US clinical trials, 3 of them open to new participants right now — about 25% of the total.

3
recruiting participants now
25%
of trials open to enrollment
2
in Phase 3–4 (later-stage)
2
top sponsor: Takeda

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 188 participants

Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

Noctem

NCT05490550

RECRUITING NA 165 participants

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

University of South Florida

NCT06345872

RECRUITING NA 20 participants

Insomnia Behavioral Intervention Study

University of Pennsylvania

NCT05301543

ACTIVE NOT RECRUITING NA 64 participants

The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

Abramson Cancer Center at Penn Medicine

NCT05226078

COMPLETED 277,920 participants

Enhancing Access to Insomnia (EASI) Care in VA PCMHI Clinics

VA Office of Research and Development

NCT04350866

COMPLETED Phase 3 405 participants

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

Takeda

NCT00671125

COMPLETED NA 195 participants

Insomnia Self-Management in Heart Failure

Yale University

NCT02660385

COMPLETED Phase 4 135 participants

Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

Takeda

NCT00492232

COMPLETED NA 132 participants

Brief Behavioral Treatment for Insomnia in Cancer Survivors

State University of New York at Buffalo

NCT03810365

COMPLETED NA 112 participants

Naturalistic Monitoring and Treatment of Chronic Insomnia

Washington State University

NCT04013321

COMPLETED Phase 2 30 participants

Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study

University of Minnesota

NCT00515177

COMPLETED NA 20 participants

Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

University of Missouri-Columbia

NCT02688569

Phase Distribution

PhaseTrial count
Phase 2 1
Phase 3 1
Phase 4 1

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

Reading the Chronic Insomnia Trial Landscape

ClinicalTrials.gov lists 12 US studies indexed under Chronic Insomnia, and 3 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 Chronic Insomnia shows 2 late-stage studies (Phase 3 and Phase 4 combined) alongside 1 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 Chronic Insomnia is led by Takeda with 2 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 12 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 Chronic Insomnia?

PlainTrial tracks 12 US clinical trials for Chronic Insomnia, of which 3 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Chronic 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.

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