Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to examine the impact of suvorexant, an FDA-approved insomnia medication, on daytime symptoms (as measured by the Daytime Insomnia Symptoms Scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. The primary hypothesis is that relative to placebo, suvorexant will improve sleep and daytime symptoms. The word "placebo" refers to a harmless pill with no therapeutic effect.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Suvorexant

Criteria

Inclusion Criteria:

• Meets Diagnostic and Statistical Manual - Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder.

• Insomnia Severity Index total score >10.

• Insomnia symptoms must include problems with wake after sleep onset.

• Insomnia symptom duration > 6 months.

• Baseline self-reported total sleep time < 6.5 hours per night.

Exclusion Criteria:

• High risk for untreated organic sleep disorders other than insomnia (narcolepsy, periodic limb movement disorder, etc) as determined by structured clinical interview and investigator clinical judgment.

• Current diagnosis of a major untreated psychiatric disorder(s).

• History of serious suicide attempt within past 5 years.

• History of alcohol or substance abuse (including prescription medication abuse) within past 5 years.

• Heavy alcohol consumption (e.g., >5 drinks per day or > 14 drinks per week.

• Heavy caffeine use [(>2 cups of coffee/day (equivalent).

• Current tobacco or nicotine use.

• History of previous allergic reaction, sensitivity, or severe side effects to sedative hypnotics.

• CYP3A inhibitors.

• Refusal to discontinue or intention to initiate OTC or other sleep aids during study period.