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

The U.S. Food and Drug Administration (FDA) has approved Orzeyful (oveporexton) for adults with narcolepsy type 1. This marks the first treatment designed to restore deficient orexin signaling, a new mechanism that distinguishes it from existing narcolepsy treatments. Clinical trials showed the oral drug, taken twice daily, improved multiple daytime and nighttime symptoms, including wakefulness, excessive daytime sleepiness, cataplexy, sleep paralysis, hallucinations, and disrupted nighttime sleep.