The FDA-approved agent showed significant impact in decreasing standard deviation of lateral position, a measure used to assess driving performance.
Results from a crossover study (NCT02806895) of patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) demonstrated that treatment with solriamfetol (Sunosi; Jazz Pharmaceuticals) improved standard deviation of lateral position (SDLP), a driving performance measure of “weaving,” at 2 and 6 hours postdose compared with placebo.
The randomized, double-blind, placebo-controlled, crossover study was presented virtually at SLEEP 2020 and led by principal investigator Johannes Ramaekers, PhD, assistant professor, department of Neurocognition, Maastricht University. Comprised of 34 participants, Ramaekers and colleagues aimed to evaluate the effects of FDA-approved solriamfetol on on-road driving performance by using SDLP at 2 hours postdose and comparing it to placebo using a repeated mixed-effects analysis of variance model.
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.
Patients were given 150 mg/day of solriamfetol, 3 times in a week and then 300 mg/day for 4 days or matching placebo. They were then asked to complete an on-road driving test at 2 hours and 6 hours postdose following the 7 days of treatment.
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At 6 hours postdose, SDLP was statistically significantly lower following solriamfetol (LS mean, 19.24 cm [SE, 0.63]) compared with placebo (20.04 cm [SE, 0.63]). The LS mean difference was –0.80 cm (95% CI, –1.58 to –0.03; P = .0432), with 3 incomplete driving tests coming from those who received solriamfetol and 7 in the placebo group.
Ramaekers and colleagues noted that headache, nausea, insomnia, dizziness, and agitation were among the most common adverse events (AEs), occurring in at least ≥5% of patients.
Of the 34 participants, 88% of them were male, with mean age of 52 years and a mean Epworth Sleepiness Scale (ESS) score of 14.4. Investigators noted that the baseline characteristics reflected the broader OSA population.
The FDA approved solriamfetol for the treatment of EDS in adults with narcolepsy or OSA in March 2019. The dual-acting dopamine and norepinephrine reuptake inhibitor was approved for narcolepsy in once-daily 75- and 150-mg doses, and in OSA in once-daily 37.5-, 75-, and 150-mg doses.
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).
Vinckenbosch F, Asin J, De Vries N, et al. Effects of solriamfetol on driving performance in participants with excessive daytime sleepiness associated with obstructive sleep apnea. Presented virtually at SLEEP 2020. Poster 0673.