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488 REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy by Michael Thorpy; Thomas Roth; Yves Dauvilliers; Clete Kushida; Colin Shapiro; Bruce Corser; Akinyemi Ajayi; Jordan Dubow; David Seiden; Russell Rosenberg is a Psychology article available to read on EtoBox.

What is 488 REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy about?

## Abstract ## Introduction Sodium oxybate (SO) is an effective treatment for narcolepsy; however, currently available formulations must be taken twice nightly. FT218 is an investigational once-nightly controlled-release formulation of SO. Here, we evaluated the efficacy of FT218 on excessive daytime sleepiness (EDS), self-reported sleep quality/refreshing nature of sleep, sleep paralysis (SP), and hypnagogic hallucinations (HH) in patients with narcolepsy. ## Methods In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, patients aged ≥16 years with narcolepsy type 1 or 2 were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night (1 week), 6.0 g/night (2 weeks), 7.5 g/night (5 weeks), and 9.0 g/night (5 weeks). Secondary efficacy endpoints included EDS using the Epworth Sleepiness Scale (ESS), sleep quality/refreshing nature of sleep using a visual analog scale (VAS), and SP and HH using a sleep symptom diary. ## Results A total of 212 patients were randomized and received study medication (FT218, n=107; placebo, n=105). Patients receiving FT218 had significant improvement vs placebo in EDS on the ESS: LS mean difference on ESS score between F

Who reads 488 REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy?

Author

Michael Thorpy; Thomas Roth; Yves Dauvilliers; Clete Kushida; Colin Shapiro; Bruce Corser; Akinyemi Ajayi; Jordan Dubow; David Seiden; Russell Rosenberg

Publisher

Oxford University Press (OUP)

Published

2021

Language

EN

Field

Psychology (Health Sciences)