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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07542756
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Insomnia
  • Chronic Insomnia Disorder
  • Insomnia
  • Insomnia Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sleep Hygiene Education — OTHER
    Standard behavioral and environmental recommendations aimed at promoting healthy sleep
  • Melatonin IR, 3 mg — DIETARY_SUPPLEMENT
    Immediate release formulation of melatonin, once nightly 30 minutes prior to bed
  • Melatonin IR, 5 mg — DIETARY_SUPPLEMENT
    Immediate release formulation of melatonin, once nightly 30 minutes prior to bed
  • Diphenhydramine, 25 mg — DRUG
    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.
  • Diphenhydramine, 50 mg — DRUG
    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.
  • Doxepin, 3 mg — DRUG
    Doxepin, 3 mg, once nightly 30 minutes prior to bed
  • Doxepin, 6 mg — DRUG
    Doxepin, 6 mg, once nightly 30 minutes prior to bed
  • Trazodone, 50 mg — DRUG
    Trazodone, 50 mg, once nightly 30 minutes prior to bed
  • Trazodone, 100 mg — DRUG
    Trazodone, 100 mg, once nightly 30 minutes prior to bed
  • Placebo — DRUG
    Placebo, once nightly 30 minutes prior to bed
  • Zolpidem, 5 mg — DRUG
    Zolpidem, 5 mg, once nightly 30 minutes prior to bed
  • Zolpidem, 10 mg — DRUG
    Zolpidem, 10 mg, once nightly 30 minutes prior to bed

Study Details

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).

Key Dates

Start date
May 1, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2032
Completion
Jan 1, 2032

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Melatonin
    Nightly 30 minutes prior to bed (3 or 5 mg)
  • Placebo Comparator: Placebo
    Nightly 30 minutes prior to bed
  • Experimental: Diphenhydramine
    Nightly 30 minutes prior to bed (25 or 50 mg). 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.
  • Experimental: Zolpidem
    Nightly 30 minutes prior to bed (5 or 10 mg)
  • Experimental: Doxepin
    Nightly 30 minutes prior to bed (3 or 6 mg)
  • Experimental: Trazodone
    Nightly 30 minutes prior to bed (50 or 100 mg)

Primary Outcome Measure

Relative treatment response rates during acute (1-month) treatment phase [ Time Frame: From treatment initiation to 1 month after treatment initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Michael L Perlis, PhD
[email protected]
215-746-3577

Find similar trials in Philadelphia, PA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
University of Pennsylvania· Philadelphia, PA

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