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

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).

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	2026-05-01
Primary Completion	2032-01-01 (estimated)
Study Completion	2032-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-05