FDA approves Orzeyful, first drug to treat all symptoms of narcolepsy type 1

The U.S. Food and Drug Administration announced on August 5, 2026 that it has approved Orzeyful (oveporexton) tablets for adults with narcolepsy type 1.

Orzeyful is the first therapy cleared to treat the entire spectrum of narcolepsy type 1 symptoms, and it works by directly restoring orexin signaling, the underlying cause of the disorder.

Narcolepsy type 1 is a rare, lifelong sleep disorder affecting about one in 2,000 Americans. Loss of orexin-producing brain cells leads to excessive daytime sleepiness, cataplexy, sleep paralysis, hallucinations and fragmented nighttime sleep.

FDA officials said the approval marks a shift from treatments that only manage individual symptoms to a medicine that targets the disease biology as a whole.