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A randomized study of solriamfetol for excessive sleepiness in narcolepsy

Annals of Neurology Feb 02, 2019

Thorpy MJ, et al. - In this phase 3 study, researchers assessed the safety and effectiveness of solriamfetol in narcolepsy. For this investigation, they randomized patients with mean sleep latency narcolepsy < 25 minutes on the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS) score ≥ 10, and usual nightly sleep ≥ 6 hours to solriamfetol 75 mg, 150 mg, or 300 mg, or placebo for 12 weeks. There were 236 and 231 patients in the safety and modified intention-to-treat populations, respectively. In patients with narcolepsy, they noted that solriamfetol has the potential to be an important therapeutic option for the treatment of impaired wakefulness and excessive sleepiness. Headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety were noted as adverse events (≥ 5% across all solriamfetol doses).

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