Modafinil, a wakefulness promoting agent, was approved to address excessive daytime sleepiness (EDS; Jha et al. 2008). Additionally, the drug was approved for use to address narcolepsy and sleeping difficulties associated with shift work (US Modafinil in Narcolepsy Multicenter Study Group 2000). Modafinil was found to enhance the quality of life for those with narcolepsy (Beusterien et al. 1999). Similar studies exploring the effectiveness of modafinil within the ABI population are limited.
Two RCTs examined the effects of modafinil on fatigue and EDS for individuals with TBI (Jha et al. 2008; Kaiser et al. 2010). The two studies followed similar protocols with the initial administration of modafinil 100 mg daily, which was then titrated up to 100 mg twice per day, and both compared with a placebo control group. Both studies found no significant difference in fatigue, as measured by the FSS, between the treatment and control groups. Further, when Kaiser et al. (2010) compared those with fatigue at baseline (FSS ≥4) in both groups, the decreases shown in FSS scores remained non-significant between groups. The two studies also examined EDS using the Epworth Sleepiness Scale (ESS). The treatment groups both showed a significantly greater decrease in ESS scores when compared with controls, representing a greater improvement in EDS (Jha et al. 2008; Kaiser et al. 2010). It should be noted, however, that Jha et al. (2008) found the improvement to be significant at week 4 (p=0.02) but not at week 10 (p=0.56) highlighting that there was no clear temporal pattern of benefit. Of concern, those receiving modafinil reported more insomnia than controls (p=0.03). These studies suggest that modafinil may not be effective for improving fatigue.
There is Level 1a evidence that modafinil is not effective in treating fatigue but has been shown to be effective short-term in treating excessive daytime sleepiness post ABI.
Modafinil has not been shown to be effective in treating fatigue.
Modafinil has been shown to be effective short-term in treating excessive daytime sleepiness, but may also cause insomnia.