Physicians now have an option to treat their patients with idiopathic hypersomnia. On Thursday, the US FDA approved the first drug to treat adults with idiopathic hypersomnia, adding a new indication to a calcium, magnesium, potassium and sodium oxybate oral solution (Xywav).

This oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients aged ≥ 7 with narcolepsy.

Adverse effects: Nausea, headache, dizziness, anxiety, vomiting

Drug interactions: Coadministration with CNS depressants including opioids, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs may cause respiratory depression, hypotension, drowsiness, syncope and death.

The active ingredient in the drug is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Hence, the drug carries a Boxed warning as a central nervous system (CNS) depressant and for its abuse and misuse potential, which can lead to seizures, respiratory depression, drowsiness, coma and death.

“Idiopathic hypersomnia is a rare chronic sleep disorder and is characterised by daytime sleepiness, prolonged nighttime sleep, difficulty waking and sleep inertia. It is associated with decreased health-related quality of life, impairment in social and work functioning, and increased motor vehicle accidents.”

(Source: US FDA & Medpage Today, August 12, 2021)