Solriamfetol and CBT-I in Patients With Insomnia Disorder

Phase 4

Active, not recruiting

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

• Registration Number: NCT05838430
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-01
• Study Start: 2023-07-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-01-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Solriamfetol+ CBT-I	Solriamfetol 75 MG	-
Solriamfetol+ CBT-I	Cognitive Behavioral Therapy for Insomnia (CBT-I)	-
Solriamfetol Only	Solriamfetol 75 MG	-
Solriamfetol Only	Monitoring	-
Placebo + CBT-I	Cognitive Behavioral Therapy for Insomnia (CBT-I)	-
Placebo + CBT-I	Placebo	-
Placebo Only	Monitoring	-
Placebo Only	Placebo	-

Primary Outcome Measures

Name	Time	Method
Sleep Continuity	End of Treatment (12 Weeks)	Reflected by total wake time \[time spent awake in bed\] as measured via a web based self-report Sleep Diary. This variable is calculated by summing the estimates for sleep latency (SL), sleep after wake onset (WASO), and early morning awakening (EMA).

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity	End of Treatment (12 Weeks)	As measured by the Insomnia Severity Index. Range of scores = 0 to 28, with a higher score indicating more severe insomnia.
Daytime Sleepiness	End of Treatment (12 Weeks)	As measured by the Epworth Sleepiness Scale. Range of scores = 0 to 24, with a higher score indicating more severe daytime sleepiness.
Fatigue	End of Treatment (12 Weeks)	As measured by Fatigue Severity Scale. Range of scores = 9 to 63, with a higher score indicating more severe fatigue.
Adherence to "sleep rescheduling"	Throughout treatment (over 8 weeks)	Sleep rescheduling is a core component of Cognitive Behavioral Therapy for Insomnia, and adherence to it will be measured by the difference between prescribed time to bed and time out of bed and actual time to bed and time out of bed as reported on daily sleep diary entries.
Daytime Function	End of Treatment (12 Weeks)	As measured by Functional Outcomes of Sleep Questionnaire (FOSQ-10) Range of scores = 10-40, with lower scores indicating more severe daytime function impairment.
Mood Disturbance	End of Treatment (12 Weeks)	Total Mood Disturbance Score on Profile of Mood States Range of scores = 0-20, with higher scores indicating more severe mood disturbance.
Alertness	Throughout treatment (over 8 weeks)	As measured by average response time (milliseconds) on a Psychomotor Vigilance Test.; Range of scores = 0 to 180000 milliseconds, with a higher score indicating lower levels of alertness.

Trial Locations

Locations (1)

University of Pennsylvania, Behavioral Sleep Medicine Program; 🇺🇸 Philadelphia, Pennsylvania, United States