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

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.