A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Pennsylvania
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sleep Hygiene Education
- Melatonin IR, 3 mg
- Melatonin IR, 5 mg
- 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
Treatment groups
1,200 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
1University of Pennsylvania19104, PhiladelphiaPennsylvania, United States
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov