The FDA approved Takeda’s orexin receptor agonist Orzeyful (twice-daily) for narcolepsy type 1, giving clinicians a new mechanism-based option for a disorder tied to orexin neuron deficiency. The approval also supports broader development of orexin-targeting therapies across sleep and other neurologic conditions where orexin signaling is implicated. Orzeyful joins a growing slate of treatments aimed at sleep-wake dysregulation, but the FDA’s narcolepsy approval is immediately actionable for prescribers managing a chronic condition with limited durable options. Takeda will now move to commercial rollout and payer contracting while monitoring early real-world uptake and safety/tolerability patterns.