Changes in mean use of airway therapy from baseline to week 40 of the open-label extension were minimal for those on solriamfetol.
Results from an open-label extension trial (NCT02348632) demonstrated that long-term treatment with solriamfetol (Sunosi; Jazz Pharmaceuticals) is safe and efficacious among patients with obstructive sleep apnea (OSA) regardless of adherence to primary OSA therapy.1
Lead author Paula K. Schweitzer, PhD, director of research, St. Luke’s Sleep Medicine and Research Center, and colleagues used the Epworth Sleepiness Scale (ESS) as the main efficacy outcome in patients with OSA who completed prior solriamfetol studies. In this open-label extension, patients received solriamfetol 75, 150, or 300 mg/day for less than or equal to 52 weeks.
At baseline of the 12-week study, mean ESS scores in adherent (n = 255) and nonadherent (n = 78) subgroups were 15.0 and 15.8, respectively. At 40 weeks of open-label treatment, mean ESS scores were 6.5 in the adherent group and 6.8 in the nonadherent subgroup. Headache, nasopharyngitis, insomnia, dry mouth, nausea, anxiety, and upper respiratory tract infection, were among the most common adverse events (AEs) among both subgroups within the study.
Primary therapy use was summarized as the percentage of nights, the number of hours per night, and the percentage of nights with use greater than or equal to 50% per night. Mean use for patients with an airway therapy at baseline was 90% of nights, 6.6 hours per night, and use of more than 50% per night occurred in 90% of nights. From baseline to week 40, the changes observed were minimal (0.9% per night, –0.8 hours per night, and 6.5% of nights, respectively).
READ MORE: Improving Standards of Sleep Apnea Care
Solriamfetol, a dual-acting dopamine and norepinephrine reuptake inhibitor, received FDA approval for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy or OSA in March 2019.2 It was approved in once-daily 75-mg and 150-mg doses for patients with narcolepsy and once daily 37.5-mg, 75-mg, and 150-mg doses for those with OSA.
Safety and efficacy of solriamfetol was established through the TONES clinical trial program. Results showed a statistically significant change in ESS and Maintenance of Wakefulness Test in patients with narcolepsy who received 300 mg or 150 mg solriamfetol compared with placebo (P <.0001) or OSA (37.5 mg, 75 mg, 150 mg, 300 mg; P <.05).
Since the TONES clinical trial program, a number of studies have continued to evaluate solriamfetol’s safety and efficacy across different measures. A crossover study presented virtually at SLEEP 2020 found that patients with EDS associated with OSA improved standard deviation of lateral position (SDLP), a driving performance measure of “weaving,” at 2 and 6 hours post treatment with solriamfetol compared with placebo.3
At 2 hours postdose, SDLP was statistically significantly lower following solriamfetol (least squares [LS] mean, 18.83 cm [standard error (SE), 0.63]) compared with placebo (19.92 cm [SE, 0.63]). There was a LS mean difference of –1.08 cm (95% CI, –1.85 to –0.32; P = .0062), which indicated better performance with solriamfetol. Notably, there was 1 subject with incomplete driving tests treated with solriamfetol and 4 administered with placebo.