Objective: To review the efficacy and safety of armodafinil for the treatment in patients with excessive sleepiness.

Data sources: Literature was accessed via MEDLINE (1966–February 2011) and EMBASE (1980–February 2011) using the medical subject heading terms armodafinil and sleep.

Study selection and data extraction: All English-language, peer-reviewed publications were analyzed for relevance. Studies appropriate to the objective were evaluated if they prospectively assessed the effectiveness of armodafinil in patients with excessive sleepiness in a multiple-dose, comparator trial. The literature search identified published reports of 7 randomized, placebo-controlled studies.

Data synthesis: Armodafinil is a wakefulness-promoting agent used in the treatment of patients with excessive sleepiness and is the R-enantiomer of modafinil. Studies have demonstrated that armodafinil may be effective and safe when used in patients with obstructive sleep apnea, circadian rhythm disorders, and narcolepsy. Although the studies identified had limited sample sizes, they consistently demonstrated improvement on various efficacy rating scales for sleep. Study durations ranged from 3 days to 12 weeks, with doses ranging from 50 mg to 250 mg daily. The most common adverse effects associated with armodafinil therapy were headache, nausea, diarrhea, dizziness, and anxiety, although increases in systolic blood pressure and pulse rate were also reported.

Conclusion: Current evidence suggests that armodafinil significantly improves wakefulness in patients with excessive sleepiness in studies up to 12 weeks. Long-term effectiveness and safety cannot be adequately determined at this time. Although armodafinil should be considered safe for use, health-care providers should monitor for adverse effects, particularly cardiovascular complications.