{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T07:17:18Z","timestamp":1791357438361,"version":"4.3.1"},"reference-count":39,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,2,28]],"date-time":"2019-02-28T00:00:00Z","timestamp":1551312000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011096","name":"Jazz Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011096","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Annals of Neurology"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Solriamfetol (JZP\u2010110) is a selective dopamine and norepinephrine reuptake inhibitor with wake\u2010promoting effects. This phase 3 study (NCT02348593) evaluated the safety and efficacy of solriamfetol in narcolepsy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with narcolepsy with mean sleep latency &lt;25\u2009minutes on the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS) score\u2009\u226510, and usual nightly sleep \u22656\u2009hours were randomized to solriamfetol 75, 150, or 300\u2009mg, or placebo for 12\u2009weeks. Coprimary endpoints were change from baseline to week 12 in MWT and ESS. Improvement on the Patient Global Impression of Change (PGI\u2010C) was the key secondary endpoint.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Safety and modified intention\u2010to\u2010treat populations included 236 and 231 patients, respectively. Solriamfetol 300 and 150\u2009mg were positive on both coprimary endpoints. Least squares mean (standard error [SE]) changes from baseline were 12.3 (SE\u2009=\u20091.4) and 9.8 (SE\u2009=\u20091.3) minutes for solriamfetol 300 and 150\u2009mg on the MWT, respectively, versus 2.1 (SE\u2009=\u20091.3) minutes for placebo, and\u2009\u22126.4 (SE\u2009=\u20090.7) for 300\u2009mg and\u2009\u22125.4 (SE\u2009=\u20090.7) for 150\u2009mg on the ESS versus \u22121.6 (SE\u2009=\u20090.7) for placebo (all <jats:italic>p<\/jats:italic> &lt;\u20090.0001). At week 12, higher percentages of patients treated with solriamfetol 150\u2009mg (78.2%) and 300\u2009mg (84.7%) reported PGI\u2010C improvement relative to placebo (39.7%; both <jats:italic>p<\/jats:italic> &lt;\u20090.0001). Adverse events \u22655% across all solriamfetol doses included headache (21.5%), nausea (10.7%), decreased appetite (10.7%), nasopharyngitis (9.0%), dry mouth (7.3%), and anxiety (5.1%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>Solriamfetol has the potential to be an important therapeutic option for the treatment of impaired wakefulness and excessive sleepiness in patients with narcolepsy. <jats:bold>ANN NEUROL 2019;85:359\u2013370.<\/jats:bold><\/jats:p><\/jats:sec>","DOI":"10.1002\/ana.25423","type":"journal-article","created":{"date-parts":[[2019,1,29]],"date-time":"2019-01-29T22:43:28Z","timestamp":1548801808000},"page":"359-370","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":159,"title":["A randomized study of solriamfetol for excessive sleepiness in narcolepsy"],"prefix":"10.1002","volume":"85","author":[{"given":"Michael 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