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A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria expanded, about 26 words Secondary endpoints: details revised at 11 of 13 entries · Study description revised Show 2 more changesShow less
    • Secondary endpoints: details revised at 11 of 13 entries
    • Study description revised
  2. Notable Recruitment opened Start date changed from estimate of May 2026 to May 1, 2026 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of May 2026 to May 1, 2026
    • Site details revised
  3. Notable Primary endpoint(s) modified Start date: May 1, 2026 to May 2026 · Eligibility criteria revised · Secondary endpoints revised (13) · 2 morev2 Show 5 more changesShow less
    • Start date: May 1, 2026 to May 2026
    • Eligibility criteria revised
    • Secondary endpoints revised (13)
    • Study description expanded, about 4 words
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk/benefit profile (doxepin).
Trial Details
NCT Number NCT07542756
Lead Sponsor University of Pennsylvania
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Insomnia, Insomnia Disorder, Chronic Insomnia, Chronic Insomnia Disorder
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov