A post-HOC analysis examining the efficacy and tolerability of armodafinil in healthcare workers with excessive sleepiness associated with shift work disorder

Introduction: Excessive sleepiness in shift workers may lead to increased workplace accidents and mistakes. The wakefulness-promoting agent armodainil has been shown to signiicantly improve clinical condition and wakefulness during the night shift and overall functioning in patients with SWD. A post-hoc analysis examined eficacy and tolerability late in the night shift of healthcare workers with SWD receiving armodainil. Methods: Patients in this 6-week study were diagnosed with SWD (DSM-IV and ICSD-2 criteria), worked at least ive 6-12 hour night shifts per month, with Global Assessment of Functioning (GAF) score <70, and mean Karolinska Sleepiness Scale (KSS) score >6. Following randomization, patients received 150 mg armodainil or placebo. Change in Clinical Global Impression-Change (CGI-C) related to excessive sleepiness late in the shift (including the commute home [0400 to 0800]), GAF, late-in-shift KSS, and modiied Sheehan Disability Scale (SDS-M) from baseline to inal visit were assessed. Final visit data included last observation carried forward. Results: Of the 383 patients enrolled in the original study, 56 (15%) were healthcare practitioners and 37 (10%) were healthcare support staff. Both populations were pooled: 47 patients received armodainil and 46 patients received placebo. The proportion of patients with an improvement in late-in-shift CGI-C from baseline was signiicantly greater in the armodainil group versus the placebo group for those patients who completed the 6-week study (72% vs. 49%; p=0.0350) but not at inal visit (67% vs. 51%; p=0.0978). Signiicant improvements in the GAF, late-in-shift KSS, and SDS-M were observed at Week 6 and inal visit. Headache was the most common adverse event. Conclusion: These results show that armodainil signiicantly improved late-in-shift clinical condition after 6 weeks of treatment. Armodainil also signiicantly improved overall functioning and late-in-shift wakefulness and reduced patient disability score. As with the overall study population, headache was the most common adverse event.