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

ConditionsInsomniaInsomnia DisorderChronic InsomniaChronic Insomnia Disorder
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Sleep Hygiene Education

    Other intervention

    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

Treatment groups

1,200 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: MelatoninExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Group C: DiphenhydramineExperimental treatment 3 interventions
Group D: ZolpidemExperimental treatment 3 interventions
Group E: DoxepinExperimental treatment 3 interventions
Group F: TrazodoneExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Relative treatment response rates during acute (1-month) treatment phase

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

Time frame
From treatment initiation to 1 month after treatment initiation
2

Relative safety and tolerability based on side effects during acute (1-month) treatment phase

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)

Time frame
From treatment initiation to 1 month after treatment initiation
3

Relative effects on daytime symptoms and function during acute (1-month) treatment phase

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

Time frame
From treatment initiation to 1 month after treatment initiation
4

Durability of treatment response during longer-term maintenance (1-6 months) treatment phase

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

Time frame
From the start of the 2nd month after treatment initiation to 6 months after treatment initiation

Secondary outcomes

1

Sleep Latency (SL)

Average self-reported Sleep Latency (SL), per sleep diary entries

Time frame
From baseline (prior to treatment), to the end of 1 month of treatment (acute treatment phase) and from the start of the 2nd month after treatment initiation to 6 months after treatment initiation (longer-term maintenance phase in responders)
2

Wake After Sleep Onset (WASO)

Average self-reported Wake After Sleep Onset (WASO), per sleep diary entries

Time frame
From baseline (prior to treatment), to the end of 1 month of treatment (acute treatment phase) and from the start of the 2nd month after treatment initiation to 6 months after treatment initiation (longer-term maintenance phase in responders)
3

Sleep Duration/Total Sleep Time (TST)

Average total sleep time (TST), calculated from daily sleep diaries

Time frame
From baseline (prior to treatment), to the end of 1 month of treatment (acute treatment phase) and from the start of the 2nd month after treatment initiation to 6 months after treatment initiation (longer-term maintenance phase in responders)
4

Self-Reported Daytime Insomnia Symptoms

As measured by The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Min. score: 0, Max score: 140. Lower score = less daytime insomnia symptoms/impairment, Higher score = more daytime insomnia symptoms/impairment

Time frame
From baseline (prior to treatment), to the end of 1 month of treatment (acute treatment phase) and from the start of the 2nd month after treatment initiation to 6 months after treatment initiation (longer-term maintenance phase in responders)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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