drugset / Trial / NCT07542756
A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
Phase 4
Recruiting
1200 enrolled
University of Pennsylvania
Patient-Centered Outcomes Research Institute · collab
RandomizedSequentialDouble-blindTreatment
Summary
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).
Timeline
- Start
- 2026-05-01
- Primary completion
- 2032-01-01
- Completion
- 2032-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diphenhydramine | Small molecule | 25 mg | — |
| Subject | Diphenhydramine | Small molecule | 50 mg | — |
| Subject | Doxepin | Unknown | 3 mg | — |
| Subject | Doxepin | Unknown | 6 mg | — |
| Subject | Trazodone | Small molecule | 50 mg | — |
| Subject | Trazodone | Small molecule | 100 mg | — |
| Subject | Zolpidem | Small molecule | 5 mg | — |
| Subject | Zolpidem | Small molecule | 10 mg | — |