Sunosi™ Approved for Excessive Daytime Sleepiness From Narcolepsy or Obstructive Sleep Apnea

Drug Maintained Its Effect After Six Months of Use

The FDA has approved solriamfetol (Sunosi, Jazz Pharmaceuticals) to improve wakefulness in adults with extreme daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). The medication is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved for excessive daytime sleepiness in adults with narcolepsy or OSA. 

OSA affects more than 18 million people in the U.S., and up to 200,000 people suffer from narcolepsy. Once-daily solriamfetol is indicated with doses of 75 mg and 150 mg for patients with narcolepsy, and with doses of 37.5 mg, 75 mg, and 150 mg for patients with OSA. At week 12, 150 mg of solriamfetol for narcolepsy patients and all doses for OSA patients demonstrated improvements in wakefulness compared to placebo.

The approval of solriamfetol is based on results from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) phase 3 clinical program, which included four randomized, placebo-controlled studies demonstrating solriamfetol’s superiority relative to placebo.

The most common adverse reactions reported among both the narcolepsy and OSA subjects were headache, nausea, decreased appetite, and anxiety. Solriamfetol was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or OSA and the drug maintained its effect relative to placebo after six months of use. 

Solriamfetol is not indicated to treat OSA’s underlying airway obstruction, which should be treated for at least one month before beginning solriamfetol for excessive daytime sleepiness in OSA. Modalities to treat the underlying airway obstruction should be continued during treatment with solriamfetol. 

Solriamfetol should not be used if patients are taking or have stopped taking within the past 14 days a monoamine oxidase inhibitor. Patients should inform their doctor if they have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol; have had a heart attack or a stroke; have kidney problems or diabetes; have a history of mental health problems or drug/alcohol abuse or addiction. It is not known if SUNOSI harms the unborn baby, or whether the drug passes into breast milk.

Source: Jazz Pharmaceuticals, March 20, 2019