Solriamfetol and CBT-I in Patients With Insomnia Disorder
Insomnia
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Medication, Fatigue, Performance, CBT-I
Eligibility 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
Sites / Locations
- University of Pennsylvania, Behavioral Sleep Medicine ProgramRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
Solriamfetol+ CBT-I
Solriamfetol Only
Placebo + CBT-I
Placebo Only