University of Pennsylvania
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).
Nearly 50% of primary care patients report symptoms of insomnia (e.g., problems initiating and/or maintaining sleep). Such sleep-related difficulties can presage new onset comorbid illness, as well as exacerbate, and be exacerbated by, existing comorbid illnesses. Accordingly, effectively treating insomnia in primary care patients is an untapped means towards the promotion of better public health. Research Question: While cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line treatment, most patients (particularly those in primary care) do not have access to this form…
Inclusion Criteria * 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 Criteria Patients will be ineligible if they meet any of the following criteria: self-rep…
Standard behavioral and environmental recommendations aimed at promoting healthy sleep
Immediate release formulation of melatonin, once nightly 30 minutes prior to bed
Immediate release formulation of melatonin, once nightly 30 minutes prior to bed
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, 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, once nightly 30 minutes prior to bed
Doxepin, 6 mg, once nightly 30 minutes prior to bed
Trazodone, 50 mg, once nightly 30 minutes prior to bed
Trazodone, 100 mg, once nightly 30 minutes prior to bed
Placebo, once nightly 30 minutes prior to bed
Zolpidem, 5 mg, once nightly 30 minutes prior to bed
Zolpidem, 10 mg, once nightly 30 minutes prior to bed
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