Solriamfetol (SUNOSI) has positive effect on symptoms of obstructive sleep apnea (OSA) regardless of patient therapy use, according to new findings.
In data presented by a team of international investigators, the dopamine-norepinephrine reuptake inhibitor (DNRI) did not differ in its benefit for excessiveness daytime sleepiness (EDS) in patients who did or did not adhere to primary sleep apnea therapy.
The trial, partially funded by SUNOSI developer Jazz Pharmaceuticals, establishes improved confidence in the novel-pathway agent’s treatment of the prevalent OSA symptom for which it is indicated.
Led by Paula K. Schweitzer, PhD, director of research at the Sleep Medicine & Research Center at St. Luke’s Hospital in Chesterfield, MO, investigators sought to answer the possibly varied effects of solriamfetol on EDS based on patient adherence to primary sleep apnea therapy. They also sought to understand whether the once-daily NDRI influenced the usage of said primary therapy.
The US Food and Drug Administration (FDA) approved solriamfetol for the treatment of EDS in adults with narcolepsy or OSA, at once-daily doses of 37.5, 75 and 150 mg for the latter condition, in March 2019.
Schweitzer and colleagues assessed solriamfetol at these daily doses, as well as 300 mg, versus placebo in patients randomized to 12 weeks of treatment. Patient were randomized based on stratification of their adherence to primary OSA therapy.
The study’s co-primary endpoints were week-12 change from baseline in Maintenance of Wakefulness Test (MWT), per 40 minutes, and Epworth Sleepiness Scale (ESS) in the modified intent-to-treat population.
Investigators reported 324 (70.6%) participants who were adherent to OSA medication, as per positive airway pressure use ≥4 hours per night on ≥70% nights, history of surgical intervention, or oral appliance use on ≥70% nights. The remaining 135 (29.4%) were not adherent.
Least squares (LS) mean differences versus placebo in MWT sleep latency in the 37.5, 75, 150, and 300 mg groups among treatment adherent participants were 4.8, 8.4, 10.2 and 12.5, respectively. Among nonadherent participants, differences were 3.7, 9.9, 11.9 and 13.5.
LS mean differences from placebo in the respective solriamfetol dose groups versus placebo were -2.4, -1.3, -4.2 and -4.7 for adherent participants. Among nonadherent participants, differences were -0.7, -2.6, -5.0 and -4.6.
“No clinically meaningful changes were seen in primary OSA therapy use with solriamfetol,” investigators observed.
Common adverse events among treated patients included headache, nausea, anxiety, decreased appetite, and nasopharyngitis.
Schweitzer and colleagues concluded the novel DNRI improves excessive daytime sleepiness in patients of obstructive sleep apnea, regardless of their primary treatment usage.
The study, “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,” was published online in CHEST Journal.