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ClinicalTrials.gov official registry

Primary Insomnia clinical trials

All 13 indexed Primary Insomnia trials have closed enrollment.

13 US clinical trials ·

Primary Insomnia is the subject of 13 registered US clinical trials on ClinicalTrials.gov, none currently recruiting. 2 are in Phase 3-4 (later-stage) and 3 in Phase 1-2 (earlier-stage). The most active sponsor is University of Rochester, running 3 of these trials.

The research picture

Primary Insomnia has 13 registered US clinical trials; none are currently listed as recruiting, so most are completed or in follow-up.

0
recruiting participants now
0%
of trials open to enrollment
2
in Phase 3–4 (later-stage)
3
top sponsor: University of Rochester
Phase 23Phase 31Phase 41

Active & Recent Trials

13 total, page 1 of 1

COMPLETED Phase 3 830 participants

6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

Sumitomo Pharma America

NCT00352144

COMPLETED NA 144 participants

Comparison of Two Temperatures to Treat Insomnia

Cereve

NCT01790256

COMPLETED NA 129 participants

The Role of Partial Reinforcement in the Long Term Management of Insomnia

University of Pennsylvania

NCT00662155

COMPLETED NA 100 participants

Behavioral Insomnia Therapy in Primary Care

US Department of Veterans Affairs

NCT00105872

COMPLETED Phase 2 72 participants

Two Contrasting Interventions for Sleep Management

University of Utah

NCT01804036

COMPLETED 45 participants

A High Density EEG Comparison of Sleep Patterns in Insomnia

University of Wisconsin, Madison

NCT01960452

COMPLETED Phase 4 40 participants

The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia

University of Rochester

NCT00124384

COMPLETED 32 participants

Metabolomics of Insomnia-Related Hyperarousal

University of Pennsylvania

NCT01957111

COMPLETED Phase 2 30 participants

Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study

University of Minnesota

NCT00515177

COMPLETED 28 participants

The Psychoneuroimmunology of Insomnia

University of Rochester

NCT00680771

COMPLETED 24 participants

Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

University of Pittsburgh

NCT00167375

COMPLETED Phase 2 20 participants

A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys

Logan College of Chiropractic

NCT00520832

COMPLETED NA 18 participants

Sleep Homeostasis in Primary Insomnia

University of Rochester

NCT00256503

Phase Distribution

PhaseTrial count
Phase 2 3
Phase 3 1
Phase 4 1

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

Reading the Primary Insomnia Trial Landscape

13 indexed Primary Insomnia studies · 0 recruiting (0%).

Phase mix: 2 late (III/IV) vs 3 early (I/II).

Top sponsor: University of Rochester (3 trials), 9 others listed. 13 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 Primary Insomnia?

PlainTrial tracks 13 US clinical trials for Primary Insomnia, of which 0 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Primary 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.