August 5, 2026 — The U.S. Food and Drug Administration today approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults — the first medicine to address the full range of symptoms of this disorder and the first to directly target its underlying biological cause.
Narcolepsy type 1 is a rare, lifelong neuropsychiatric sleep disorder affecting approximately 1 in 2,000 people in the U.S. It is caused by the loss of orexin-producing brain cells, leading to excessive daytime sleepiness, cataplexy (sudden muscle weakness triggered by emotions), sleep paralysis, hallucinations, and disrupted nighttime sleep.
Unlike existing treatments that only manage individual symptoms, Orzeyful directly activates the same brain receptor that orexin would normally stimulate, restoring the missing signal. It is taken orally twice daily.
The approval was supported by two randomized, double-blind, placebo-controlled 12-week studies involving 273 adults. Patients taking Orzeyful showed improved ability to stay awake, reduced daytime sleepiness, fewer cataplexy episodes, and meaningful improvement across all narcolepsy symptoms compared with placebo.
Common side effects included insomnia, increased urinary frequency, urgency to urinate, and increased saliva production. Discontinuation rates due to side effects were low. Orzeyful should not be used with strong CYP3A inhibitors. Safety and efficacy in patients under 18 have not been established.
Orzeyful received Breakthrough Therapy Designation and Priority Review from the FDA. The approval was granted to Takeda Pharmaceuticals America, Inc.
