Armodafinil.

Armodafinil is the R-enantiomer of modafinil, a wake-promoting agent, that primarily affects areas of the brain involved in controlling wakefulness. Once-daily armodafinil was effective in improving wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome (OSA) [despite treatment of the underlying condition], narcolepsy or shift work sleep disorder (SWSD) in four large (n > 195), double-blind, multinational trials of 12 weeks' duration. Compared with placebo, mean sleep latency (coprimary endpoint) was significantly improved with armodafinil 150 or 250 mg once daily in patients with OSA or narcolepsy, and with armodafinil 150 mg once daily in patients with SWSD, as assessed by the Multiple Sleep Latency Test (MSLT) or the Maintenance of Wakefulness Test (MWT). Furthermore, a significantly higher proportion of armodafinil than placebo recipients achieved a response (at least a minimal improvement) on the Clinical Global Impressions of Change (CGI-C) scale at study end in these four trials (coprimary endpoint). Once-daily armodafinil was generally well tolerated in adult patients with excessive sleepiness associated with OSA (despite treatment of the underlying condition), narcolepsy or SWSD.

RCT Entities:   Population Interventions Outcomes