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Can a sleep drug boost brain power in seniors?

NCT ID NCT05908526

Symptom relief Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested suvorexant (Belsomra), an FDA-approved sleep medication, in 40 older adults with insomnia. Participants took the drug or a placebo for two weeks while wearing a motion tracker and completing smartphone surveys about their sleep, mood, and thinking. The goal was to see if suvorexant improves not just nighttime sleep but also daytime symptoms like fatigue and concentration.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
suvorexant (Belsomra)
What this could lead to
If it works, this could point toward a treatment that improves both sleep and daytime functioning in older adults with insomnia.
What could go wrong
This is a small Phase 2 trial with only 40 participants, so results may not apply to everyone. Suvorexant can cause side effects like daytime drowsiness or dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Oct 2023

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia

Contacts and locations

Locations

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.