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New combo therapy for insomnia shows promise in sleep study

NCT ID NCT05838430

Symptom relief Sponsor: University of Pennsylvania 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a medication called solriamfetol, cognitive behavioral therapy for insomnia (CBT-I), or both together can help people with insomnia sleep better and feel less tired during the day. 115 adults with insomnia took part. The goal was to see if staying awake longer during the day could help consolidate sleep at night.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

115 people

The number who actually took part.

Started

Jul 2023

Finished

Apr 2026

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

25 to 60 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: • Participants will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5). In addition, the complaint of disturbed sleep will meet the following criteria: * ≥ 30 minutes to fall asleep (SL) and/or ≥ 2 awakenings per night of ≥ 15 minutes duration and/or wake after sleep onset (WASO) time of ≥ 30 minutes where total sleep time (TST) did not exceed 6 hours (unless sleep efficiency \[SE\] is ≤ 80%). * The problem is present for \> 3 nights per week. * The problem duration exceeds ≥ 6 months. * The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both. * Preferred regular sleep phase between 10:00 PM and 8:00 AM * Must garner physician's assent from their primary care clinician Exclusion Criteria: * Use of medication expressly for the purpose of falling or staying asleep (e.g., trazodone/ desyrel, melatonin, Tylenol PM, Nyquil, Benadryl). * Night shift work * Compromised renal function * Major Coronary Artery Disease and/or uncontrolled (with meds) Hypertension * Planning to become pregnant, pregnant, and/or breastfeeding * Unstable medical or psychiatric illness * Symptoms suggestive of sleep disorders other than insomnia * Polysomnographic data indicating sleep disorders other than insomnia * Evidence of active illicit substance use, abuse, or dependence * Use of CNS active medications that are for treatment of insomnia or are thought to have caused insomnia as a side effect * Inadequate language comprehension * Current or past experience with CBT-I * No access to the computers, I-Pads, or the internet

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Conditions

The condition(s) this trial relates to.

Fatigue 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 Pennsylvania, Behavioral Sleep Medicine Program

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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