Armodafinil for Patients with Shift Work Disorder

Philadelphia—It is estimated that 21 million people in the United States work shifts outside of the normal workday, which is defined as any time from 6 am to 6 pm. People who work at night or on early morning shifts are at an increased risk for shift work disorder (SWD), a circadian rhythm sleep disorder. SWD is characterized by excessive nighttime sleepiness and daytime insomnia in adults whose work hours fall outside of the normal sleep period; 45% of shift workers report these symptoms.

Among nurses, shift patterns that include night work cause long-term stress and fatigue; higher fatigue is associated with poor job-related performance. Among medical residents, those who worked frequent shifts of ≥24 hours made significantly more medical errors compared with residents who worked shorter shifts.

Armodafinil (R-modafinil), a longer-lasting R-stereoisomer of racemic modafinil, is indicated for the treatment of excessive sleepiness in SWD, as well as obstructive sleep apnea and narcolepsy in the United States. Researchers recently conducted a large 12-week, randomized controlled study of 254 permanent or rotating night-shift workers with SWD. The study was conducted at 42 sleep research facilities in North America. The patients worked at least five 6- to 12-hour night shifts per month, had a Global Assessment of Functioning (GAF) score of <70, and late-in-shift sleepiness identified by a mean Karolinska Sleepiness Scale (KSS) score of ≥6.

The current analysis was a post hoc analysis of that study. The primary objective was to assess the efficacy and safety of armodafinil for the treatment of SWD in a subset of healthcare practitioners and healthcare support staff who worked permanent or rotating night shifts. Results were presented in a poster session at the APA meeting. The poster was titled An Analysis of the Efficiency and Tolerability of Armodafinil in Healthcare Workers with Excessive Sleepiness Associated with Shift Work Disorder.

The subset of healthcare workers included 47 who received armodafinil and 46 who received placebo. Of the 93 healthcare workers in the subset, 56 were healthcare practitioners (60%) and 37 were healthcare support staff (40%).

At weeks 3 and 6, a significantly greater proportion of those who received armodafinil had at least minimal improvements in the Clinical Global Impressions-Change Scale (CGI-C) score late in their shift compared with those in the placebo group (80% in the armodafinil group vs 51% in the placebo group at week 3 and 72% in the armodafinil group vs 49% in the placebo group at week 6; P<.05 for both comparisons).

Improvements from baseline in GAF score were significantly greater in the armodafinil group compared with the placebo group at week 3, week 6, and at the final visit (8.7 in the armodafinil group vs 4.1 in the placebo group at week 3, 10.2 vs 3.5 at week 6, and 9.6 vs 4.0 at final visit; P<.05 for all comparisons). 

Improvements in late-in-shift sleepiness (assessed by reductions in KSS score) were significantly greater among those in the armodafinil group compared with those in the placebo group at week 3, week 6, and final visit (-2.8 vs -1.6 at week 3; -3.1 vs -1.5 at week 6; and -3.1 vs -1.5 at final visit; P<.05 for all comparisons).

Finally, participants in the armodafinil group had significant improvement on the modified Sheehan Disability Scale (SDS-M) at week 3 and week 6 in composite scores over baseline and at the final visit (all P<.05 vs placebo).

In conclusion, the researchers said, “In this subpopulation post hoc analysis, healthcare workers who received armodafinil had significant improvement from baseline in late-in-shift CGI-C, as well as meaningful improvements in GAF, late-in-shift KSS, and SDS-M.”

This study was supported by Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceuticals Industries, Ltd.