Solriamfetol and CBT-I in Patients With Insomnia Disorder

Description

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.

Conditions

Insomnia

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Study Overview

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Study Details

Study overview

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.

The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia Disorder

Solriamfetol and CBT-I in Patients With Insomnia Disorder

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Philadelphia

University of Pennsylvania, Behavioral Sleep Medicine Program, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

25 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Study Record Dates

2025-12-28