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

IF 0.6 Q4 CLINICAL NEUROLOGY

Future Neurology Pub Date : 2022-07-14 DOI:10.2217/fnl-2022-0005

C. Kushida, M. Thorpy, J. Flygare, A. Roy, J. Dubow, D. Seiden

{"title":"Once-nightly sodium oxybate (FT218) improved symptoms in people with narcolepsy: a plain language summary of publication","authors":"C. Kushida, M. Thorpy, J. Flygare, A. Roy, J. Dubow, D. Seiden","doi":"10.2217/fnl-2022-0005","DOIUrl":null,"url":null,"abstract":"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. 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. 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","PeriodicalId":12606,"journal":{"name":"Future Neurology","volume":"1 1","pages":""},"PeriodicalIF":0.6000,"publicationDate":"2022-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Future Neurology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2217/fnl-2022-0005","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

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. 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. 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

查看原文本刊更多论文

每晚一次的氧酸钠(FT218)改善嗜睡症患者的症状:发表的简明语言摘要

这是最初发表在《睡眠》杂志上的一篇文章的简单语言总结。每晚一次的氧酸钠(简称ON-SXB);也被称为FT218)是一种治疗日间过度嗜睡(简称EDS)和突发性肌肉无力(即猝倒)的潜在方法。美国食品和药物管理局(FDA)正在决定是否批准ON-SXB用于成人嗜睡症患者。REST-ON临床研究观察ON-SXB在治疗发作性睡症症状方面是否优于不含药物的替代品(称为安慰剂)。这项研究的结果表明，服用ON-SXB的人能够在白天保持清醒的时间更长，白天的困倦感更少，发作更少，总体上比服用安慰剂的人有更大的改善。ON-SXB的常见副作用是恶心、呕吐、头晕、尿床和头痛。如果得到FDA的批准，嗜睡症患者可能可以选择一种只需在睡前服用一次的氧化钠。他们可以避免在半夜服用第二剂。ClinicalTrials.gov NCT编号:NCT02720744

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Future Neurology CLINICAL NEUROLOGY-

CiteScore

2.10

自引率

0.00%

发文量

期刊介绍： The neurological landscape is changing rapidly. From the technological perspective, advanced molecular approaches and imaging modalities have greatly increased our understanding of neurological disease, with enhanced prospects for effective treatments in common but very serious disorders such as stroke, epilepsy, multiple sclerosis and Parkinson’s disease. Nevertheless, at the same time, the healthcare community is increasingly challenged by the rise in neurodegenerative diseases consequent upon demographic changes in developed countries.