The FDA approved Takeda’s orexin receptor agonist for narcolepsy type 1, clearing the twice-daily treatment for a patient population defined by orexin neuron deficiency. The decision launches a new commercial and clinical chapter for orexin-based therapy in sleep medicine. Regulators’ action comes alongside a push for next-generation sleep disorder therapeutics, where mechanism-based differentiation has been a key development theme. For clinicians, the approval provides an additional option in a space where therapeutic needs often extend beyond symptom control. For the broader industry, the approval reinforces that orexin modulation remains a viable path for neurological therapeutics with clear patient stratification.