Once-nightly sodium oxybate (FT218) improved symptoms in people with narcolepsy: a plain language summary of publication

Clete A. Kushida, Michael J. Thorpy, Julie Flygare, Asim Roy, Jordan Dubow, David Seiden

Research output: Contribution to journalReview articlepeer-review

Abstract

What is this summary about? This is a plain language summary of an article originally published in the journal Sleep. Once-nightly sodium oxybate (ON-SXB for short; also known as FT218) is a potential treatment for excessive daytime sleepiness (EDS for short) and sudden muscle weakness known as cataplexy. The US Food and Drug Administration (FDA) is deciding whether to approve ON-SXB to be prescribed to adults with narcolepsy. The REST-ON clinical study looked at whether ON-SXB was better than a substitute that had no medicine in it (called a placebo) at treating narcolepsy symptoms. What were the results? The results of this study showed that people who took ON-SXB were able to stay awake longer during the day, felt less sleepy in the daytime, had less cataplexy, and were more improved overall than people who took placebo. Common side effects with ON-SXB were nausea, vomiting, dizziness, bedwetting, and headache. What do the results mean? If approved by the FDA, people with narcolepsy may have the option to choose a form of sodium oxybate that they only have to take once at bedtime. They could avoid taking a second middle-of-the-night dose. ClinicalTrials.gov NCT number: NCT02720744 </sec.

Original languageEnglish (US)
Article numberFNL60
JournalFuture Neurology
Volume17
Issue number5
DOIs
StatePublished - Sep 1 2022
Externally publishedYes

Keywords

  • efficacy
  • lay summary
  • narcolepsy
  • once-nightly
  • plain language summary
  • REST-ON
  • safety
  • sodium oxybate

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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