The impact of shift duration on the efficacy and tolerability of armodafinil in patients with excessive sleepiness associated with shift work disorder
Objective: To examine the impact of night-shift duration (<= 9 hours or >9 hours) on efficacy and tolerability of armodafinil in patients with shift work disorder (SWD). Methods: This was a post hoc analysis of a 6 week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Shift workers with diagnosed SWD and late-in-shift sleepiness (between 4 AM and 8 AM, including the commute home) received armodafinil 150 mg or placebo before their night shift. Results: Proportion of patients with at least minimal improvement in late-in-shift sleepiness, late-in-shift Clinical Global Impressions-Change (CGI-C) rating and Karolinska Sleepiness Scale (KSS), as well as overall Global Assessment of Functioning (GAF) scale and modified Sheehan Disability Scale (SDS-M), were assessed at baseline and final visit. Results: Of the 383 patients enrolled, 279 (73%) worked shifts <= 9 hours and 104 (27%) worked shifts >9 hours. A greater percentage of patients receiving armodafinil had at least minimal improvement in late-in-shift CGI-C (<= 9 hours: 78% vs 60%, P = 0.0017; >9 hours: 77% vs 46%, P = 0.0020) regardless of shift duration. Armodafinil patients also demonstrated significantly greater improvements in GAF score (<= 9 hours: 9.5 vs 5.4, P<0.0001; >9 hours: 9.6 vs 4.3, P = 0.0019) and KSS score (<= 9 hours: -2.9 vs -1.9, P = 0.0002; >9 hours: -2.8 vs -1.6, P = 0.00 28). Improvement in SDS-M composite score was significantly greater for armodafinil patients working >9 hours (-6.8 vs -2.7, P = 0.0086). Headache was the most frequent adverse event in all treatment groups. Conclusions: Patients receiving armodafinil had significantly greater improvements in late-in-shift clinical condition and in wakefulness and overall global functioning than did placebo-treated patients, regardless of shift duration. Prospectively designed, randomized clinical trials that include objective measures of sleepiness are needed to support these findings.
CURRENT MEDICAL RESEARCH AND OPINION
(2014). The impact of shift duration on the efficacy and tolerability of armodafinil in patients with excessive sleepiness associated with shift work disorder. CURRENT MEDICAL RESEARCH AND OPINION, 30(5), 945-951.
Available at: http://aquila.usm.edu/fac_pubs/8080