FDA Approves First Drug for Full Range of Narcolepsy Symptoms

THURSDAY, Aug. 6, 2026 (HealthDay News) — The U.S. Food and Drug Administration has approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults.

Orzeyful marks the first medicine approval for the full range of symptoms associated with narcolepsy type 1 and is the first approved drug to work by directly targeting the loss of orexin signaling that causes the disease.

The approval is based on two randomized, double-blind, placebo-controlled studies enrolling 273 adults with narcolepsy type 1. Across 12 weeks, patients taking Orzeyful (2 mg) in both studies showed improvements in their ability to stay awake during the day versus those assigned to placebo. Patients also reported a significant reduction in cataplexy episodes, as well as meaningful improvement across sleep paralysis, hallucinations, and disrupted nighttime sleep. Insomnia, increased urinary frequency, urgency to urinate, and increased saliva production were the most common reported side effects.

“For too long, people with narcolepsy type 1 have had to manage a complex, lifelong neuropsychiatric condition with treatments that only address pieces of it,” Tiffany R. Farchione, M.D., from the FDA Center for Drug Evaluation and Research, said in a statement. “This new drug is the first medicine that impacts the underlying biology of the disease, treating narcolepsy type 1 as a whole.”

Approval of Orzeyful was granted to Takeda Pharmaceuticals.

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