Schedule IV Designation For Solriamfetol, a New Treatment for Excessive Daytime Sleepiness in Narcolepsy or OSA

The Drug Enforcement Agency DEA has designated solriamfetol (Sunosi; Jazz Pharmaceuticals, Philadelphia, PA) a schedule IV agent, meaning that it has low potential for abuse or dependence. Solriamfetol was approved for treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) in March, 2017 and pooled efficacy and safety data were recently presented at SLEEP2019 as reported by Practical Neurology previously.

"Jazz Pharmaceuticals focuses on doing what is best for patients and we are committed to the safe and appropriate use of our medicines for debilitating conditions like excessive daytime sleepiness associated with narcolepsy or OSA," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We are pleased that Sunosi has received a schedule IV designation that aligns with our research demonstrating this medicine's relatively low potential for abuse and risk of dependence."

Solriamfetol is expected to be commercially available in early July.