Solriamfetol and CBT-I in Patients With Insomnia Disorder

• Status: Not yet recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia [CBT-I]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Axsome Therapeutics, Inc.

Criteria

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