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.
Description
The current proposal is for a one-year study to investigate whether solriamfetol can improve sleep continuity and daytime performance, alone and in combination with Cognitive Behavioral Therapy for Insomnia. It is expected (given a common mechanism [wake extension]) that both Cognitive Behavioral Therapy for Insomnia and treatment with solriamfetol will improve sleep continuity, and that such effects will potentially be additive.
Eligibility
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