Modafinil/armodafinil for excessive daytime sleepiness after traumatic brain injury: a systematic review and meta-analysis.

IF 1.8 4区医学 Q4 NEUROSCIENCES

Brain injury Pub Date : 2025-08-01 Epub Date: 2025-05-19 DOI:10.1080/02699052.2025.2502424

Rafael Batista João, Niels Pacheco-Barrios, Marianna Leite, Ygor Roberto Ramos Gonçalves Soares, Zeynep Eylül Bakir, Maria Eduarda Veiga, Julyana Medeiros Dantas

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引用次数: 0

Abstract

Objectives: Previous studies investigated pharmacological options for reducing excessive daytime sleepiness (EDS) after traumatic brain injury (TBI), with mixed results. This meta-analysis aimed to assess the efficacy and safety of modafinil or armodafinil in post-TBI persons experiencing EDS.

Methods: We systematically searched PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov and identified studies comparing modafinil/armodafinil versus placebo for treating EDS after TBI. We computed pooled risk ratios (RR) or mean differences (MD) for binary and continuous outcomes, respectively. EDS was assessed using the Epworth Sleepiness Scale (ESS).

Results: We included data from 158 individuals (mean age 34.28 years; 62.64% male) from three randomized controlled trials. In those treated with modafinil (dose range: 100-400 mg) or armodafinil (dose range: 150-250 mg), the mean ESS score was decreased in comparison with placebo (MD -1.65; 95% CI -3.26 to -0.04; p = 0.04). The risk of insomnia was higher in the modafinil/armodafinil group compared with the placebo group (RR 3.73; 95% CI 1.11 to 12.54; p = 0.03). There was no significant difference between groups in the risk of other adverse events (e.g., nausea, headache, dizziness, and nasopharyngitis).

Conclusion: Modafinil/armodafinil effectively improved EDS after TBI, as compared with placebo, albeit with an increased risk of insomnia.

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莫达非尼/阿莫达非尼治疗创伤性脑损伤后白天嗜睡：系统回顾和荟萃分析。

目的：先前的研究探讨了减少创伤性脑损伤（TBI）后白天过度嗜睡（EDS）的药物选择，结果好坏参半。本荟萃分析旨在评估莫达非尼或阿莫达非尼在脑外伤后发生EDS的患者中的疗效和安全性。方法：我们系统地检索了PubMed、Embase、Cochrane Library、Web of Science和ClinicalTrials.gov，并确定了比较莫达非尼/armodafinil与安慰剂治疗脑外伤后EDS的研究。我们分别计算了二元结局和连续结局的合并风险比（RR）或平均差异（MD）。EDS采用Epworth嗜睡量表（ESS）进行评估。结果：我们纳入了158例个体(平均年龄34.28岁；62.64%男性)，来自三个随机对照试验。在接受莫达非尼（剂量范围：100-400 mg）或阿达非尼（剂量范围：150-250 mg）治疗的患者中，与安慰剂相比，平均ESS评分降低(MD -1.65；95% CI -3.26 ~ -0.04；p = 0.04)。与安慰剂组相比，莫达非尼/阿莫达非尼组失眠的风险更高(RR 3.73；95% CI 1.11 ~ 12.54；p = 0.03)。组间其他不良事件（如恶心、头痛、头晕和鼻咽炎）的风险无显著差异。结论：与安慰剂相比，莫达非尼/阿莫达非尼有效改善脑外伤后EDS，尽管失眠风险增加。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Brain injury 医学-康复医学

CiteScore

3.50

自引率

5.30%

发文量

148

审稿时长

12 months

期刊介绍： Brain Injury publishes critical information relating to research and clinical practice, adult and pediatric populations. The journal covers a full range of relevant topics relating to clinical, translational, and basic science research. Manuscripts address emergency and acute medical care, acute and post-acute rehabilitation, family and vocational issues, and long-term supports. Coverage includes assessment and interventions for functional, communication, neurological and psychological disorders.