Solriamfetol and CBT-I in Patients With Insomnia Disorder

University of Pennsylvania

Status and phase: Active, not recruiting; Phase 4

Conditions: Insomnia

Treatments: Other: Placebo; Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I); Drug: Solriamfetol 75 MG; Other: Monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05838430

850945

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Solriamfetol+ CBT-I

Experimental group

Treatment:

Drug: Solriamfetol 75 MG

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Solriamfetol Only

Experimental group

Treatment:

Other: Monitoring

Drug: Solriamfetol 75 MG

Placebo + CBT-I

Active Comparator group

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Other: Placebo

Placebo Only

Placebo Comparator group

Treatment:

Other: Monitoring

Other: Placebo