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The Drug Enforcement Agency (DEA) has designated Sunosi (solriamfetol; Jazz Pharmaceuticals) a Schedule IV controlled substance.
Sunosi, a first-in-class dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), was approved in March 2019 to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). However, it is not indicated to treat the underlying airway obstruction in OSA; patients should receive OSA therapy for at least 1 month prior to initiating Sunosi for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi.
According to findings from a human abuse potential study, Sunosi produced Drug Liking scores similar to or lower than phentermine, a Schedule IV substance. As such, the DEA placed solriamfetol in Schedule IV of the Controlled Substances Act.
Commenting on the scheduling, Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals said, “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.”
Sunosi is expected to be available in 75mg (functionally scored) and 150mg tablets in early July.
For more information visit sunosi.com.
