Takeda’s FDA-approved Orzeyful expands treatment to all narcolepsy symptoms, challenging existing sleep drugs

The U.S. Food and Drug Administration approved Takeda's drug Orzeyful in August, marking the first therapy that addresses the full spectrum of narcolepsy symptoms, including cataplexy and excessive daytime sleepiness.

Orzeyful is expected to pressure the current market leaders, notably Jazz Pharmaceuticals' Xywav and Xyrem, as well as Harmony Biosciences' Wakix. Jazz's rare sleep franchise generated more than $2 billion in revenue last year, while Harmony reported $868.5 million from Wakix.

Alkermes, which acquired Lumryz through its takeover of Avadel Pharmaceuticals, forecasts sales of about $335 million for the drug this year. Additional competition comes from Axsome Therapeutics' Sunosi, which posted $124.8 million in sales, and from generic versions of Xyrem.

The approval opens the door for other companies developing orexin‑targeting therapies, intensifying a competitive landscape that already includes several sodium oxybate‑based products.