Jazz Daytime Sleepiness Drug Approved

FDA has approved a Jazz Pharmaceuticals NDA for Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Once-daily Sunosi is approved with doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and 150 mg for patients with OSA. The company says it is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat excessive daytime sleepiness in adults living with narcolepsy or OSA.

Approval was based on data showing that at week 12, Sunosi 150 mg for narcolepsy patients and all doses for OSA patients demonstrated improvements in wakefulness compared to placebo, Jazz says. “The most common adverse reactions (incidence greater than 5% and higher than placebo) reported in both the narcolepsy and OSA study populations were headache, nausea, decreased appetite, and anxiety.