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Background <p>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.</p> Methods <p>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 &lt; 10, standard deviation of lane position (SDLP) score, and adverse events (including anxiety, dizziness). This paper was registered in INPLASY (INPLASY2024120052).</p> Results <p>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&#xa0;mg was more effective than other treatments in reducing ESS scores (<Emphasis Type="BoldUnderline">MD</Emphasis> =  −4.74, 95%CI: −6.51,-2.97) and prolonging sleep latency (<Emphasis Type="BoldUnderline">MD</Emphasis> = 10.82&#xa0;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 &lt; 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 the highest risk of gastrointestinal adverse effects such as diarrhea [8.53, (1.14,263)] and vomiting [29.5, (2.46,1.46e+03)], pitolisant induced the highest risk of nausea [4.22e+08, (4.09,1.26e+32)], and SXB+modafinil had the highest risk of dizziness [7.67, (1.01,58.7)]. There were no considerable differences among drugs in other adverse effects.</p> Conclusion <p>All of the approved new wake-promoting drugs are effective in controlling narcolepsy symptoms with acceptable adverse effects.</p> <p><i>Trial Registration</i> The study was prospectively registered in the INPLASY database (INPLASY2024120052).</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月13日

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  • Zian Yan,
  • Jiwei Li,
  • Yixin Yu,
  • Shenghan Qiu,
  • Bing Wang,
  • Jiyou Tang

摘要

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 the highest risk of gastrointestinal adverse effects such as diarrhea [8.53, (1.14,263)] and vomiting [29.5, (2.46,1.46e+03)], pitolisant induced the highest risk of nausea [4.22e+08, (4.09,1.26e+32)], and SXB+modafinil had the highest risk of dizziness [7.67, (1.01,58.7)]. There were no considerable differences among drugs in other adverse effects.

Conclusion

All of the approved new wake-promoting drugs are effective in controlling narcolepsy symptoms with acceptable adverse effects.

Trial Registration The study was prospectively registered in the INPLASY database (INPLASY2024120052).