The US Food and Drug Administration has approved a new indication for Xywav for the treatment of idiopathic hypersomnia, a chronic sleep disorder. The disorder causes people to be excessively sleepy during the day, even after a sound sleep the night before.
Xywav is already approved for excessive daytime sleepiness in patients with narcolepsy. The active ingredient of the drug is oxybate which is a controlled substance. Given its potential risks, Xywav will be subject to strict safety controls, the FDA said in an announcement on 12 August.