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Comparative efficacy of new wake-promoting agents for narcolepsy-a network meta-analysis

Yan Z, Li J, Yu Y, Qiu S, Wang B, Tang J

BMC neurology, 2025

Abstract

Background: As a rare sleep disorder, narcolepsy is treated with various therapeutic options. This article systematically analyzes the efficacy and safety of novel approved wake-promoting drugs.

Methods: Randomized controlled trials (RCTs) for patients with narcolepsy and treated with approved interventions were searched. Outcome measures included Epworth sleepiness scale (ESS) score, mean latency in the maintenance of wakefulness test (MWT), cataplexy frequency, number of subjects with ESS scores < 10, standard deviation of lane position (SDLP) score, and adverse events (including anxiety, dizziness). This paper was registered in INPLASY (INPLASY2024120052).

Results: The final analysis included 13 RCTs with four drugs involved: modafinil/armodafinil, sodium oxybate (SXB), pitolisant, and solriamfetol, at different dosages or combinations. All drugs were effective in treating narcolepsy compared to placebo. Solriamfetol 300 mg was more effective than other treatments in reducing ESS scores (MD = -4.74, 95%CI: -6.51,-2.97) and prolonging sleep latency (MD = 10.82 min, 95%CI: 6.99, 14.31). Several novel wake-promoting drugs did not show significant differences in improving cataplexy frequency, the number of people with ESS scores < 10, and SDLP scores. The novel wake-promoting drugs compared in this article could improve adverse effects, but some drugs showed an elevated likelihood of some adverse effects compared to controls or other drugs. Compared to placebo, SXB yielded…

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