FDA Approves First Orexin-Targeted Treatment, Orzeyful, for Narcolepsy Type 1

The U.S. Food and Drug Administration (FDA) has approved Orzeyful (oveporexton) for adults with narcolepsy type 1, marking the first treatment designed to restore deficient orexin signaling. Clinical trials showed the twice-daily oral drug improved wakefulness, excessive daytime sleepiness, cataplexy, and other symptoms. Common side effects included insomnia and urinary issues.