The FDA has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for popular treatments from Jazz Pharmaceuticals.

Avadel said the drug, called Lumryz, was now approved to treat pediatric patients with sudden muscle weakness called cataplexy or for excessive daytime sleepiness, both symptoms of narcolepsy. It was approved for adults in 2023.

Lumryz's main area of differentiation from Jazz Pharma's Xyrem and Xywav is its once-nightly dosing that eliminates the need to wake up in the middle of the night, Needham analyst Ami Fadia said.

Avadel's drug contains a central nervous system depressant drug called sodium oxybate, which helps increase the amount of time someone spends in deep sleep. Children make up about 5% of the current oxybate-treated population.

While Jazz's sleep disorder drugs are approved for the same condition as Lumryz, Xywav has the FDA's expanded nod to treat idiopathic hypersomnia, a rare neurological condition that causes excessive sleepiness.

Lumryz comes with a boxed warning for reduced stimulation of the central nervous system, and for its potential for abuse and misuse.

The FDA's decision on Lumryz was expected in September, but it was extended after the health regulator said the drug was still under review.