Solriamfetol, a dopamine norepinephrine reuptake inhibitor, improves excessive daytime sleepiness (EDS) in obstructive sleep apnea (OSA) regardless of adherence to primary OSA therapy, according to study results published in CHEST (Clinicaltrials.gov Identifier: NCT02348606).
The researchers wanted to find out whether solriamfetol had different effects on EDS based on adherence to primary OSA therapy. In addition, they examined whether solriamfetol affects primary OSA therapy by randomly assigning participants to placebo or solriamfetol 37.5, 75, 150, or 300 mg per day for 12 weeks (stratified according to primary OSA therapy adherence) .
At the start of the study, the researchers found that 324 (70.6%) participants were adherent (positive airway pressure ≥ 4 h / night in ≥ 70% nights, surgery or oral device use in ≥ 70% nights) and 135 (29.4%) ). The participants were not adherent. Mean Least Squares (LS) differences from placebo in sleep latency while maintaining wakefulness test (MWT) in the 37.5, 75, 150, and 300 mg groups among adherent participants were 4.8, 8 , 4, 10.2, and 12.5 minutes The non-adherent participants included 3.7, 9.9, 11.9, and 13.5 minutes.
According to the Epworth Sleepiness Scale (ESS), the mean LS differences in the placebo score in the 37.5, 75, 150 and 300 mg groups among the adherent participants were -2.4, -1.3, -4.2 and -4.7. and among the non-adherent participants were -0.7, -2.6, -5.0 and -4.6. Common adverse events reported were headache, nausea, anxiety, decreased appetite, nasopharyngitis and diarrhea. No clinically meaningful changes were observed with solriamfetol primary OSA therapy.
“Solriamfetol was effective in treating EDS in subjects with OSA regardless of adherence / non-adherence to primary OSA therapy, and treatment with solriamfetol did not change participants’ use of primary OSA therapy,” the study authors concluded . “The inclusion of participants who adhered to and did not adhere to primary OSA therapy improves the generalizability of these results in practice.”
Disclosure: This clinical study was supported by Jazz Pharmaceuticals. For a full list of the authors’ information, see the original reference.
Schweitzer PK, Mayer G., Rosenberg R. et al. Solriamfetol Randomized Controlled Trial for Daytime Drowsiness in Obstructive Sleep Apnea: An Analysis of Subgroups of Persistent or Non-Persistent Treatment for Obstructive Sleep Apnea. CHEST. Published online on February 22, 2021. doi: 10.1016 / j.chest.2021.02.033
This article originally appeared on Pulmonology Advisor