Solriamfetol (Sunosi) to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
Solriamfetol is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA for this indication.
Taken once daily by mouth, the drug is approved in 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.
Can provide sustained wakefulness throughout the day.
Four randomized placebo-controlled studies that demonstrated the superiority of solriamfetol relative to placebo.
Solriamfetol was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or OSA and was shown to maintain its effect relative to placebo after 6 months of use.
Solriamfetol for patients with narcolepsy and all doses for patients with OSA demonstrated improvements in wakefulness compared with placebo.
The most common adverse reactions reported in the narcolepsy and OSA study populations are headache, nausea, decreased appetite, and anxiety.