Solriamfetol Wins FDA Approval for Excessive Daytime Sleepiness in Narcolepsy, Obstructive Sleep Apnea

Richard K. Bogan, MD, FCCP, FAASM

The US FDA has approved solriamfetol (Sunosi, Jazz Pharmaceuticals) for the treatment of excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.

The dual-acting dopamine and norepinephrine reuptake inhibitor is approved for narcolepsy in once-daily 75 mg and 150 mg doses, and in obstructive sleep apnea in once-daily 37.5 mg, 75 mg, and 150 mg doses.

“Sunosi is an effective treatment option with a novel mechanism of action as a dual-acting dopamine and norepinephrine reuptake inhibitor," said Richard K. Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine and chief medical officer at SleepMed in Columbia, said in a statement.¹ "Excessive daytime sleepiness is the most common symptom for people with narcolepsy and a major complaint of people with obstructive sleep apnea. In some people with obstructive sleep apnea, excessive daytime sleepiness may persist despite using CPAP."

Safety and efficacy of solriamfetol was established through the TONES clinical trial program. Results showed a statistically significant change in Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test in patients with narcolepsy who received 300 mg or 150 mg solriamfetol compared with placebo (P <.0001) or obstructive sleep apnea (37.5 mg, 75 mg, 150 mg, 300 mg; P <.05).

Adverse events reported in ³5% of patients included headache, nausea, decreased appetite, and anxiety. No serious adverse events were recorded.

Solriamfetol is not indicated to treat airway obstruction associated with obstructive sleep apnea; patients with obstructive sleep apnea should be treated with continuous positive airway pressure for at least 1 month prior to initiating treatment with solriamfetol, and should be continued throughout treatment with solriamfetol. The drug is contraindicated in patients who currently take or recently stopped taking monoamine oxidase inhibitors for depression. Those with a history of heart problems, hypertension, kidney problems, diabetes, or high cholesterol; those who have had a heart attack or stroke; patients with a history of mental health disorders or drug or alcohol abuse; and those who are pregnant, planning to become pregnant, and currently or planning to breastfeed should undergo careful consideration prior to initiating treatment with solriamfetol. Patients who take solriamfetol while pregnant are encouraged to participate in the pregnancy registry.

Solriamfetol is expected to become commercially available soon after the US Drug Enforcement Administration makes its final scheduling decision, typically within 90 days of FDA approval.

WATCH

: Geert Mayer, MD, neurologist and sleep specialist at Philipps University of Marburg in Germany, discusses long-term data on solriamfetol.

REFERENCE

1. Jazz Pharmaceuticals annouces US FDA approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea [news release]. Dublin, Ireland: Jazz Pharmaceuticals; March 20, 2019. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-sunositm