RecruitingPhase 4NCT07542756

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

Sequential Multiple Assignment Randomized Trial Comparing Commonly Prescribed and Over the Counter Medications for the Treatment of Insomnia in Adults

Sponsor

University of Pennsylvania

Enrollment

1,200 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Insomnia Chronic Insomnia Insomnia Disorder Chronic Insomnia Disorder

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Diphenhydramine, 25 mg, a drug called Diphenhydramine, 50 mg, and others for people with chronic insomnia, chronic insomnia disorder, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSleep Hygiene Education

Standard behavioral and environmental recommendations aimed at promoting healthy sleep

DIETARY_SUPPLEMENTMelatonin IR, 3 mg

Immediate release formulation of melatonin, once nightly 30 minutes prior to bed

DIETARY_SUPPLEMENTMelatonin IR, 5 mg

Immediate release formulation of melatonin, once nightly 30 minutes prior to bed

DRUGDiphenhydramine, 25 mg

Diphenhydramine 25 mg, once nightly 30 minutes prior to bed. Note: Given the strong recommendation against the use of diphenhydramine in older adults (i.e., the Beers Criteria), participants ≥64 years of age will not be randomized to the diphenhydramine arm.

DRUGDiphenhydramine, 50 mg

Diphenhydramine, 50 mg, once nightly 30 minutes prior to bed. Note: Given the strong recommendation against the use of diphenhydramine in older adults (i.e., the Beers Criteria), participants ≥64 years of age will not be randomized to the diphenhydramine arm.

DRUGDoxepin, 3 mg

Doxepin, 3 mg, once nightly 30 minutes prior to bed

DRUGDoxepin, 6 mg

Doxepin, 6 mg, once nightly 30 minutes prior to bed

DRUGTrazodone, 50 mg

Trazodone, 50 mg, once nightly 30 minutes prior to bed

DRUGTrazodone, 100 mg

Trazodone, 100 mg, once nightly 30 minutes prior to bed

DRUGPlacebo

Placebo, once nightly 30 minutes prior to bed

DRUGZolpidem, 5 mg

Zolpidem, 5 mg, once nightly 30 minutes prior to bed