@article{da48acc28953465cb7113ea3dc2d1c52,
title = "Once-nightly sodium oxybate (FT218) improved symptoms in people with narcolepsy: a plain language summary of publication",
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 ",
keywords = "REST-ON, efficacy, lay summary, narcolepsy, once-nightly, plain language summary, safety, sodium oxybate",
author = "Kushida, {Clete A.} and Thorpy, {Michael J.} and Julie Flygare and Asim Roy and Jordan Dubow and David Seiden",
note = "Funding Information: CA Kushida (Department of Psychiatry and Behavioral Sciences, Stanford University Medical Center, Redwood City, CA, USA) has received payment for consulting or serving on advisory boards for Avadel Pharmaceuticals, XW Pharma, and Jazz Pharmaceuticals. MJ Thorpy (Department of Neurology, Montefiore Medical Center, New York, NY, USA) has received payment for speaking, consulting, or serving on advisory boards for Axsome Therapeutics, Balance Therapeutics, Eisai, Avadel Pharmaceuticals, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences Ltd., and Takeda Pharmaceutical Co. J Flygare (Project Sleep) has received payment for consulting for Avadel Pharmaceuticals and Jazz Pharmaceuticals, and for presenting to employees and at a focus group meeting of payer representatives for Takeda Pharmaceuticals Co. A Roy (Ohio Sleep Medicine and Neuroscience Institute, Dublin, OH, USA) has received grant/research support for Jazz Pharmaceuticals, Suven, Inspire, Nyxoah, LivaNova, and Avadel Pharmaceuticals and has received payment for speaking, consulting, or serving on advisory boards for Jazz Pharmaceuticals, Suven, Inspire, and Avadel Pharmaceuticals. J Dubow is a former employee of Avadel Pharmaceuticals and has received payment for consulting to Avadel. D Seiden is an employee of Avadel Pharmaceuticals Publisher Copyright: {\textcopyright} 2022 The Authors.",
year = "2022",
month = sep,
day = "1",
doi = "10.2217/fnl-2022-0005",
language = "English (US)",
volume = "17",
journal = "Future Neurology",
issn = "1479-6708",
publisher = "Future Medicine Ltd.",
number = "5",
}