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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

In general, the common early-onset TEAEs reported during week 1 were similar between participants with OSA and participants with narcolepsy, although rates were higher among participants with narcolepsy. To summarize, common early-onset

TEAEs for participants with OSA included headache, nausea, decreased  appetite,  anxiety, insomnia, and feeling jittery, whereas common early-onset TEAEs for participants with narcolepsy included headache, nausea, decreased appetite, and dry

mouth. The incidence of new or increased-severity early-onset TEAEs identified during week 1 decreased over time in both populations, with most events being mild to moderate in severity. At approved doses (≤ 150 mg), headache, nausea, and feeling jittery had median durations ≤ 8 days, whereas decreased appetite, anxiety, insomnia, and dry mouth had longer durations. Finally, 25 (7.0%) and 9 (5.1%) of participants receiving solriamfetol had TEAEs leading to study drug discontinuation compared with 4 (3.4%) and 1 (1.7%) receiving placebo for OSA and narcolepsy, respectively. Among those with TEAE- related discontinuations of solriamfetol, common early-onset TEAEs accounted for 44% and 11% of TEAE-related discontinuations in participants with OSA and narcolepsy respectively.

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