Solriamfetol and CBT-I in Patients With Insomnia Disorder

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.

"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."

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.

Placebo, identical in appearance to the active drug.