Efficacy Of Modafinil On Excessive Daytime Sleepiness Associated With Parkinson’s Disease:A Systematic Review And Meta-analysis

Background: Daytime sleepiness is a common type of sleep disorder relatived to Parkinson’s disease(PD),and it is known to increase the risk of accidents and to generate a social issue,so we should take its treatment seriously. Modafinil is a novel wake-promoting agent approved by the FDA ameliorating excessive daytime sleepiness(EDS). Existing trials of modafinil for EDS associated with Parkinson’s disease are few,only a small part of them are randomized controlled trial.Objectives: This meta-analysis aimed to assess the efficacy of modafinil for daytime sleepiness in PD,thereby,we can provide the best treatment with evidence-based medicine proof for EDS associated with Parkinson’s disease.Methods:A Meta-analysis based on Pubmed,Embase and The Cochrane Central Register of Controlled Trials(Jan 1980-Jan 2016)was conducted to identify published randomized controlled trials on the effect of modafinil on EDS associated with Parkinson’s disease. The search terms were Parkinson’s disease,PD,excessive daytime sleepiness,somnolence, hypersomnia,modafinil,et al.Results:Four studies were included. A total of 120 patients were enrolled. Meta-analysis of the four trials suggested a therapeutic effect of modafinil on EDS in patients with Parkinson’s disease,as assessed by the Epworth Sleepiness Scale(ESS)(MD-1.99 95% CI-3.02--0.95,P=0.0002<0.05,I2=33%).Conclusions: A meta-analysis of existing RCTs of modafinil for EDS associated with Parkinson’s disease demonstrated a clear beneficial effect. But all of the studies had small sample sizes and the majority of them just assessed by subjective ESS scores rather than objective MSLT scores, modafinil is not yet sufficient to be recommended for for EDS associated with PD until solid data are available.Hence,the higher quality,larger sample, multi-center RCTs are expected.