Sunosi Scheduled Under the Controlled Substances Act
June 17, 2019 – The U.S. Drug Enforcement Agency (DEA) has designated Jazz Pharmaceuticals’ Sunosi™ (solriamfetol) as a Schedule IV substance under the Controlled Substances Act (CSA). Sunosi received U.S. FDA approval in March 2019 as the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients who have excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).
Schedule IV is the second-lowest schedule for controlled substances. It includes medications [such as Xanax® (alprazolam) and Soma® (carisoprodol)] that have a low potential for abuse relative to Schedule III substances [such as Suboxone® (buprenorphine) and ketamine]. Although abuse and dependence may occur, the probability of misuse is low.
According to the manufacturer, Sunosi will launch in July 2019 in 75mg and 100mg tablets. Pricing is not yet available.