Sleep disorders

FDA Approves First Treatment for a Chronic Sleep Disorder

The US Food and Drug Administration (FDA) has approved Xywav for the treatment of idiopathic hypersomnia (IH) in adults. This is the first drug to be approved by the FDA for the uncommon chronic sleep disorder.

This approval was based on a double-blind placebo-controlled randomized withdrawal study. Included were 154 patients with IH aged between 19 to 75 years. The results of the study indicated that those who were switched to placebo experienced worse symptoms of IH than those who continued normal treatment with Xyway.

Xyway has a black box warning for central nervous system depression as well as abuse and misuse, which can cause serious adverse effects, such as seizures, coma, and death.

Due to the black box warning, Xyway must be prescribed and dispensed under the Risk Evaluation and Mitigation Strategy (REMS) program. Xyway can only be prescribed by a certified prescriber and dispensed from a certified pharmacy to an enrolled patient.

Common side effects of Xyway include nausea, headache, dizziness, anxiety, and vomiting.

“A novel indication for Xyway is significant as the FDA has never granted an approval for idiopathic hypersomnia,” said the deputy director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, Eric Bastings, MD. “Idiopathic hypersomnia is a life-long condition, and the approval of Xyway will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder.”


—Leigh Precopio



FDA grants first of its kind indication for chronic sleep disorder treatment. News release. US Food and Drug Administration; August 12, 2021.