Medications for Insomnia

Overseen By Mark Seewald, MSW

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Pennsylvania

Must not be taking: CNS active drugs

Disqualifiers: Unstable psychiatric, medical conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of 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).

Who Is on the Research Team?

Michael L Perlis, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Inclusion Criteria

Score ≥15 on the Insomnia Severity Index (ISI)

Meet DSM-5 criteria for Insomnia Disorder

Sleep initiation and/or maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights/week, with a duration of ≥3 months

Exclusion Criteria

Inadequate English language comprehension

I have or am at high risk for other sleep disorders or work rotating shifts.

Acute or unstable psychiatric conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nightly doses of either prescription or OTC medications for insomnia, with dose adjustments after 2 weeks if needed

4 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants who respond to treatment are monitored for safety and effectiveness over a longer-term maintenance phase

5 months

Monthly check-ins (virtual or in-person)

Re-randomization

Non-responders are re-randomized to alternative treatment arms to find an effective medication

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Diphenhydramine
• Doxepin
• Melatonin
• Trazodone
• Zolpidem

How Is the Trial Designed?

Group I: Zolpidem Experimental Treatment 3 Interventions

Nightly 30 minutes prior to bed (5 or 10 mg)

Group II: Trazodone Experimental Treatment 3 Interventions

Nightly 30 minutes prior to bed (50 or 100 mg)

Group III: Melatonin Experimental Treatment 3 Interventions

Nightly 30 minutes prior to bed (3 or 5 mg)

Group IV: Doxepin Experimental Treatment 3 Interventions

Nightly 30 minutes prior to bed (3 or 6 mg)

Group V: Diphenhydramine Experimental Treatment 3 Interventions

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.

Group VI: Placebo Placebo Group 2 Interventions

Nightly 30 minutes prior to bed

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+