SMART Trial Comparing Prescription and OTC Medications for Insomnia in Adults
ClinicalTrials.gov Studies
Summary
The NIH has registered a new Phase 4 clinical trial (NCT07542756) comparing prescription insomnia medications (zolpidem, trazodone, doxepin) against over-the-counter alternatives (melatonin, diphenhydramine) in adults with insomnia disorder. The SMART Trial will assess relative effectiveness, safety, and durability across multiple dosage combinations and includes a placebo arm. Study interventions range from 3-100 mg across 11 treatment arms.
What changed
A new Phase 4 clinical trial has been registered on ClinicalTrials.gov comparing commonly prescribed prescription insomnia medications (zolpidem, trazodone, doxepin) with over-the-counter options (melatonin, diphenhydramine) in adults diagnosed with insomnia disorder, chronic insomnia, or insomnia disorder. The trial includes 11 intervention arms spanning doses from 3 mg to 100 mg, plus sleep hygiene education and placebo comparators.
Healthcare providers, clinical investigators, and trial sponsors involved in insomnia research may find this trial relevant for understanding comparative effectiveness benchmarks. Drug manufacturers of the studied compounds (zolpidem, trazodone, doxepin, diphenhydramine) should monitor results for potential competitive implications in the insomnia treatment market.
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Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
SMART Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in Adults
Phase 4 NCT07542756 Kind: PHASE4 Apr 21, 2026
Abstract
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).
Conditions: Insomnia, Insomnia Disorder, Chronic Insomnia, Chronic Insomnia Disorder
Interventions: Melatonin IR, 3 mg, Melatonin IR, 5 mg, Sleep Hygiene Education, Diphenhydramine, 25 mg, Diphenhydramine, 50 mg, Doxepin, 3 mg, Doxepin, 6 mg, Trazodone, 50 mg, Trazodone, 100 mg, Placebo, Zolpidem, 5 mg, Zolpidem, 10 mg
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