Data from a phase IV trial of armodafinil (Nuvigil®) for excessive sleepiness associated with shift work disorder have been presented at the Society of General Internal Medicine’s 34th Annual Meeting.

This 6-week, double-blind, placebo-controlled study involved 383 patients from 45 sites across the US, randomised to 150mg armodafinil (n=177) or placebo (n= 182). The primary endpoint was the Clinical Global Impression of Change (CGI-C) scale which evaluates the change from baseline (beginning of the study) in overall clinical condition late in the shift – from 4:00 a.m. to 8:00 a.m. The observation period also included the participant’s commute home from work. Using the CGI-C rating, at the final visit, 77% patients taking armodafinil improved, compared to 57% taking placebo (p<0.0001). The most frequently reported adverse events in this study are similar to those described in the prescribing information form the drug, and include headache, nausea, and insomnia.