FDA approves Sunosi for excessive daytime sleepiness

The FDA approved the first and only dual-acting dopamine and norepinephrine reuptake inhibitor, Sunosi, to treat excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, according to a press release issued by the drug’s manufacturer.

“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea 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,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in the release. “The FDA approval of Sunosi also represents an important milestone for Jazz as we continue to offer new treatment options that address unmet needs for people living with chronic, and often debilitating, sleep disorders.”

Sunosi (solriamfetol, Jazz Pharmaceuticals) is approved in once-daily doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and 150 mg for patients with obstructive sleep apnea (OSA), according to the release.

The approval is based on four placebo-controlled studies from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) phase 3 clinical program that assessed the safety and efficacy of solriamfetol in 900 adults with excessive daytime sleepiness associated with narcolepsy or OSA, according to the release.

The FDA approved the first and only dual-acting dopamine and norepinephrine reuptake inhibitor, Sunosi, to treat excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

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All studies demonstrated that solriamfetol was superior to placebo in terms of improvements in wakefulness, with 68% to 74% of participants on the 75-mg dose regimen and 78% to 90% of participants on the 150-mg dose regimen showing improvement in their overall condition, according to the release. This effect was maintained after 6 months of use, according to the release.

The most common adverse events associated with solriamfetol in patients with narcolepsy or OSA included headache, nausea, decreased appetite and anxiety, according to the release.

Solriamfetol is not intended to treat the underlying airway obstruction in OSA, according to the release.

Disclosure: Cozadd is employed by Jazz Pharmaceuticals.