The US FDA has just approved the first treatment for adult idiopathic hypersomnia, a condition in which patients experience chronic excessive daytime sleepiness, sleep inertia, prolonged yet non-restorative nighttime sleep and naps, and cognitive impairment. Xywav®, previously approved for the treatment of cataplexy and excessive daytime sleepiness associated with narcolepsy, is an oral solution of calcium, magnesium, potassium, and sodium oxybates that significantly improved scores on the Epworth Sleepiness Scale, the Patient Global Impression of Change, and the Idiopathic Hypersomnia Severity Scale in a Phase III study when administered once or twice nightly. Side effects included nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis (i.e., excessive sweating), vomiting, diarrhea, dry mouth parasomnia, somnolence, fatigue, and tremor. However, this newly-approved treatment is a welcome option for the 37,000 patients with idiopathic hypersomnia in the United States.
>> Jazz Pharmaceuticals Press Release
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