NCT05838430

Solriamfetol and CBT-I in Patients With Insomnia Disorder

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Solriamfetol 75 MG	Solriamfetol (trade name Sunosi), is a norepinephrine-dopamine reuptake inhibitor available in 75mg and 150mg tablets for oral administration during the day. Solriamfetol's primary indication is to treat excessive daytime sleepiness (EDS) in patients diagnosed with obstructive sleep apnea or Narcolepsy. It binds to the dopamine and the norepinephrine transporters with affinities (Ki) of 14.2 μM and 3.7 μM, respectively),does not undergo significant metabolism in humans, and has a Tmax of \~2 hours (range 1.25-3.0 hours) and a T1/2 of \~7.1 hours.
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia (CBT-I)	Treatment will be conducted via a HIPAA compliant video link (Zoom). Sessions 1-8 will follow our published protocol (published in 2005 by Springer). Each session will be conducted individually and have a singular focus per session. All sessions following the delivery of sleep restriction therapy \& stimulus control instructions (post Session 2) will include, as needed, management of non-adherence and/or time-in-bed titration.
OTHER	Monitoring	No CBT-I will be administered, however, the tracking system used for CBT-I will be used for all subject conditions. This includes a sleep disorder symptoms screener, the administration of several questionnaires on a weekly basis, and the administration of daily sleep diaries online or via iPhone. Note: it is a common effect that regular monitoring of this type produces perceived clinical benefit.
OTHER	Placebo	Placebo, identical in appearance to the active drug.

Timeline

• Start date: 2023-07-31
• Primary completion: 2026-01-31
• Completion: 2026-04-30
• First posted: 2023-05-01
• Last updated: 2025-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study