FDA Approves Solriamfetol for Treatment of Excessive Daytime Sleepiness

The Food and Drug Administration (FDA) has approved solriamfetol (Sunosi; Jazz Pharmaceuticals, Dublin, Ireland) for the treatment of adults with excessive daytime sleepiness (EDS)associated with narcolepsy or obstructive sleep apnea (OSA). Solriamfetol is a dual dopamine and norepinephrine reuptake inhibitor (DNRI)  taken once daily at a dose of 37.5 mg (OSA only), 75 mg, or 150 mg. Pending approval by the Drug Enforcement Agency (DEA), which is expected within 90 days, solriamfetol is expected to be available by the third quarter of 2019. 

In a clinical trial (NCT02348606), patients with OSA had improvements in scores on the Maintenance of Wakefulness sleep latency test (MWT) and the Epworth Sleepiness scale (ESS) compared with those given placebo (P < .005). Improvements were dose dependent and occurred after the first week of treatment at all doses. For patients with narcolepsy, clinical trial NCT02348593 showed improvements after treatment with solriamfetol vs placebo (P < .0001). The most common treatment-emergent adverse reactions (incidence ≥ 5% and higher than placebo) were headache, nausea, decreased appetite, and anxiety. Improved wakefulness lasted approximately 9 hours after taking the medication. Solriamfetol remained effective after 6 months of treatment. 

"EDS can negatively impact the daily lives of people living with narcolepsy or OSA at work, at home or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.