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Evaluating Common Insomnia Medications

This study is looking at how well common over-the-counter (OTC) and prescription medications work for insomnia. These include melatonin (3 mg and 5 mg), diphenhydramine (25 mg and 50 mg), zolpidem (Ambien), trazodone, and doxepin. It also includes sleep hygiene education, which are standard tips for healthy sleep. Researchers want to see which treatments are most effective, safest, and how long their benefits last over one month. You might be able to join if you are 18-80 years old, have chronic insomnia (insomnia disorder), and are willing to stop other sleep medications before starting. The study aims to enroll 1200 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 1200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures treatment response, safety, and effects on daytime symptoms for one month after treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07542756

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

Recruiting
PHASE4Ages 18–80InterventionalTreatment
University of Pennsylvania
~1,200 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Sleep Hygiene EducationMelatonin IR, 3 mgMelatonin IR, 5 mgDiphenhydramine, 25 mgDiphenhydramine, 50 mgDoxepin, 3 mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative treatment response rates during acute (1-month) treatment phase
Measured over From treatment initiation to 1 month after treatment initiation
+5 more outcomes measured

Conditions

Insomnia
Insomnia Disorder
Chronic Insomnia
Chronic Insomnia Disorder

Explore related trials

Insomnia

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Michael L Perlis, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Michael L Perlis, PhD
[email protected]
215-746-3577
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults aged 18-80 years.
Meet DSM-5 criteria for Insomnia Disorder.
Score ≥15 on the Insomnia Severity Index (ISI).
Sleep initiation and/or maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights/week, with a duration of ≥3 months.
Willingness to discontinue use of all sleep-related medications prior to enrollment.
Completion of a 2-week washout period before starting any study medication.
Willingness to provide clinician assent for participation.

Exclusion

Age \< 18 or \> 80 years old
Inadequate English language comprehension
Minimal facility with smartphones, computers, i-Pads, or the internet.
Acute or unstable psychiatric conditions
Unstable medical condition, significant medical disorder, or acute illness (as determined by their PCP), within one month prior to the study period.
Significant liver or kidney problems
Pheochromocytoma or porphyria (contraindicated for trazodone)
Epilepsy or Seizure Disorder (contraindicated for trazodone)
Glaucoma or urinary retention (contraindicated for doxepin)
Increased ocular pressure (contraindicated for diphenhydramine)
Diagnosis of alcohol or substance use disorder within 2 years prior to the screening visit
Inability to refrain from drinking alcohol or substance use for at least 3 consecutive days
Any lifetime history of (diagnosis of) breathing disorders, including COPD and sleep apnea.
Shift work related sleep disorder (work \~11pm to 7am and "day sleeper") and rotating shiftwork schedules
Circadian rhythm disorders (phase advance or phase delay syndromes)
Self-reported usual daytime napping ≥1 hour per day (3 or more days per week)
Known hypersensitivity or contraindication to study drugs
Known hypersensitivity or contraindication to drugs of the same class as the study treatments
Known hypersensitivity or contraindication to any excipients of the study drug formulation
Treatment with CNS active drugs prohibited by the protocol for five half-lives of the respective drug (or 2 weeks)
Heavy tobacco use (≥1 pack of cigarettes a day or inability to refrain from smoking during the night)
Not able or willing to stop treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors

What this trial measures

  • Relative treatment response rates during acute (1-month) treatment phaseFrom treatment initiation to 1 month after treatment initiation

    Defined as an at least 8-point reduction on the Insomnia Severity Index (ISI)

  • Relative safety and tolerability based on side effects during acute (1-month) treatment phaseFrom treatment initiation to 1 month after treatment initiation

    Percent of participants who experience 1 or more side effect(s), as well as the average number of events, incidence rate, and severity of events for each medication, as assessed by self-report (spontaneous and based on a weekly medical symptoms checklist)

  • Relative effects on daytime symptoms and function during acute (1-month) treatment phaseFrom treatment initiation to 1 month after treatment initiation

    As measured by the Functional Outcomes of Sleep Questionnaire (FOSQ- 10). Min. score: 5, Max Score: 20 Lower score = more functional impairment Higher score = less functional impairment

  • Durability of treatment response during longer-term maintenance (1-6 months) treatment phaseFrom the start of the 2nd month after treatment initiation to 6 months after treatment initiation

    Among initial treatment responders based on Insomnia Severity Index (ISI) and tolerability, the percent of subjects who continue to exhibit an ISI-based treatment response

  • Relative safety and tolerability based on side effects during longer-term maintenance (1-6 months) phaseFrom the start of the 2nd month after treatment initiation to 6 months after treatment initiation

    Among initial treatment responders based on ISI and tolerability, percent of participants who experience 1 or more side effect(s), as well as the average number of events, incidence rate, and severity of events for each medication, as assessed by self-report (spontaneous and based on a weekly medical symptoms checklist)

  • Durability of effects on daytime symptoms and function during longer-term maintenance (1-6 months) phaseFrom the start of the 2nd month after treatment initiation to 6 months after treatment initiation

    Among initial treatment responders based on Insomnia Severity Index (ISI) and tolerability, the relative improvements in on the Functional Outcomes of Sleep Questionnaire (FOSQ- 10). Min. score: 5, Max Score: 20. Lower score = more functional impairment, higher score = less functional impairment