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