Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy

Journal of Clinical Sleep MedicineRosenberg R, Thorpy MJ, Dauvilliers Y, et al. | July 22, 2021

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In this post-hoc analysis, researchers sought to describe the weekly incidence and overall duration of common early-onset treatment-emergent adverse events (TEAEs) during solriamfetol treatment. Participants with obstructive sleep apnea [OSA] (n = 474) and narcolepsy (n = 236) were randomly assigned to 12 weeks of placebo or solriamfetol 37.5 (OSA only), 75, 150, or 300 mg. The incidence of new occurrence or change in severity over time for common early-onset TEAEs (those occurring in ≥5% of participants in any solriamfetol dose group and with a higher incidence than that observed in placebo-treated participants during week 1) was calculated for each subsequent study week. Common early-onset TEAEs included headache, nausea, decreased appetite, as well as anxiety, insomnia, and feeling jittery in OSA and dry mouth in narcolepsy. The majority of common early-onset TEAEs with solriamfetol are transient, with the majority disappearing within the first week of treatment. The majority of TEAEs were mild to moderate in severity.

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