Jazz Pharmaceuticals plc announced that the European Commission approved Sunosi® (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat EDS in adults living with narcolepsy or OSA and the only licensed therapy in the European Union for the treatment of EDS in adults living with OSA. Once-daily Sunosi is approved with doses of 75 mg and 150 mg for people with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for patients with OSA. At Week 12 of the Phase 3 clinical trial, 150 mg of solriamfetol for narcolepsy patients and both 75 mg and 150 mg doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed via the maintenance of wakefulness test from approximately one hour post-dose through approximately nine hours post-dose. The Marketing Authorisation Application (MAA) for Sunosi is based on data from four randomised placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) clinical trial program. Data from the studies in the TONES program demonstrated the superiority of solriamfetol relative to placebo. The most frequently reported adverse reactions were headache (11.1%), nausea (6.6%) and decreased appetite (6.8%). The most serious and frequently occurring adverse reactions were increased blood pressure and palpitations. The majority of most frequently reported adverse events occurred within the first two weeks of treatment and resolved for most patients within 2 weeks. Solriamfetol was evaluated in more than 900 adults with EDS associated with narcolepsy or OSA and was shown to maintain its effect relative to placebo after six months of use. In the TONES 2 and TONES 3 12-week clinical studies in narcolepsy and OSA patients, respectively, approximately 68-74% of people taking solriamfetol at the 75 mg dose and 78-90% of people taking solriamfetol at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change (PGIc) scale.