Solriamfetol, a dopamine-norepinephrine reuptake inhibitor, improves excessive daytime sleepiness (EDS) in obstructive sleep apnea (OSA) regardless of primary OSA therapy adherence, according to study results (Clinicaltrials.gov Identifier: NCT02348606) published in CHEST.
Researchers sought to determine whether solriamfetol has differential effects on EDS based on adherence to primary OSA therapy. In addition, they examined whether solriamfetol affects primary OSA therapy usage by randomly assigning participants to 12 weeks of placebo or solriamfetol 37.5, 75, 150, or 300 mg per day (stratified by primary OSA therapy adherence).
At baseline, the researchers noted that 324 (70.6%) participants were adherent (positive airway pressure use ≥4 h/night on ≥70% nights, surgical intervention, or oral appliance use on ≥70% nights) and 135 (29.4%) participants were nonadherent. Least squares (LS) mean differences from placebo in Maintenance of Wakefulness Test (MWT) sleep latency in the 37.5-, 75-, 150-, and 300-mg groups among adherent participants were 4.8, 8.4, 10.2, and 12.5 minutes, and among nonadherent participants were 3.7, 9.9, 11.9, and 13.5 minutes.
According to the Epworth Sleepiness Scale (ESS), LS mean differences in score from placebo in the 37.5-, 75-, 150-, and 300-mg groups among adherent participants were -2.4, -1.3, -4.2, and -4.7, and among nonadherent participants were -0.7, -2.6, -5.0, and -4.6. Common adverse events that were reported included headache, nausea, anxiety, decreased appetite, nasopharyngitis, and diarrhea. No clinically meaningful changes were observed in primary OSA therapy use with solriamfetol.
“Solriamfetol was effective in the treatment of EDS in participants with OSA, regardless of adherence/nonadherence to primary OSA therapy, and treatment with solriamfetol did not alter participants’ use of primary OSA therapy,” the study authors concluded. “The inclusion of participants who were adherent and nonadherent to primary OSA therapy enhances the generalizability of these results in the real-world setting.”
Disclosure: This clinical trial was supported by Jazz Pharmaceuticals. Please see the original reference for a full list of authors’ disclosures.
Schweitzer PK, Mayer G, Rosenberg R, et al. Randomized controlled trial of solriamfetol for excessive daytime sleepiness in obstructive sleep apnea: an analysis of subgroups adherent or nonadherent to obstructive sleep apnea treatment. CHEST. Published online February 22, 2021. doi:10.1016/j.chest.2021.02.033