USA: Solriamfetol improves excessive daytime sleepiness (EDS) in obstructive sleep apnea (OSA) regardless of primary OSA therapy adherence, finds a recent study in the journal Chest.
Solriamfetol is a dopamine-norepinephrine reuptake inhibitor that is approved in the USA for improving wakefulness in people with EDS associated with OSA. Paula K. Schweitzer, St. Luke's Hospital, Chesterfield, MO, USA, and colleagues aimed to determine whether solriamfetol have differential effects on EDS based on adherence to primary OSA therapy and does solriamfetol affect primary OSA therapy usage.
Participants were randomized to 12 weeks of placebo or solriamfetol 37.5, 75, 150, or 300 mg/d (stratified by primary OSA therapy adherence).
Coprimary endpoints were week-12 change from baseline in Maintenance of Wakefulness Test (40-minute MWT) and Epworth Sleepiness Scale (ESS) in the modified intent-to-treat population. The researchers evaluated primary OSA therapy use (hours/night, % nights) and safety.
Key findings of the study include:
At baseline, 324 (70.6%) participants were adherent (positive airway pressure use ≥4 hours/night on ≥70% nights, surgical intervention, or oral appliance use on ≥70% nights) and 135 (29.4%) nonadherent.
Least squares (LS) mean differences (95% CI) from placebo in MWT sleep latency (minutes) in the 37.5-, 75-, 150-, and 300-mg groups among adherent participants were 4.8, 8.4, 10.2, 12.5 and among nonadherent participants were 3.7, 9.9, 11.9, 13.5.
On ESS, LS mean differences from placebo in the 37.5-, 75-, 150-, and 300-mg groups among adherent participants were -2.4, -1.3, -4.2, -4.7 and among nonadherent participants were -0.7, -2.6, -5.0, -4.6 (-7.0, -2.3).
Common adverse events: headache, nausea, anxiety, decreased appetite, nasopharyngitis, diarrhea.
No clinically meaningful changes were seen in primary OSA therapy use with solriamfetol.
"Solriamfetol improved EDS in OSA regardless of primary OSA therapy adherence. Primary OSA therapy use was unaffected with solriamfetol," wrote the authors.
The study titled, "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," is published in the journal CHEST.
DOI: https://journal.chestnet.org/article/S0012-3692(21)00341-X/