Phase 2 N=40 Randomized Double-blind Treatment

Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes

Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT05908526 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Change in Daytime Insomnia Symptoms Scale (DISS) — 65.96; 70.34; 69.22; 72.32 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Baseline surveys, Cognitive testing and EMAs (Behavioral); Actiwatch (Device); suvorexant (or placebo) (Drug); Placebo (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Daytime Insomnia Symptoms Scale (DISS)	65.96; 70.34; 69.22; 72.32; 69.72; 71.08	—
PRIMARY Change in Insomnia Severity as Assessed by Insomnia Severity Index	-9.6; -5.5	—
SECONDARY Change in Sleepiness as Assessed by Epworth Sleepiness Scale	-4.2; -2.3	—
SECONDARY Change in Depression as Assessed by Patient Health Questionnaire-9	-2.3; -2.2	—
SECONDARY Change in Anxiety as Assessed by Generalized Anxiety Disorder-7	-3.2; -1.6	—
SECONDARY Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses	3.33; -1.13	—
SECONDARY Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time	17.97; -10.23	—
SECONDARY Change in Cognitive Performance Assessed by the Stroop Test: Accuracy	-0.02; 0.02	—
SECONDARY Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds	-131.3; -403.6	—
SECONDARY Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds	-158.01; -278.42	—
SECONDARY Change in Cognitive Performance Assessed by the Task-switching	0.01; 0.02	—

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.

Eligibility 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05908526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.