The impact of shift duration on the efficacy and tolerability of armodafinil in patients with excessive sleepiness associated with shift work disorder. (May 2014)

• Record Type: Journal Article
• Authors: Harsh, John; Yang, Ronghua; Hull, Steven G.
• Is Part Of: Current medical research and opinion. Volume 30:Number 5(2014:May)
• Page Start: 945
• Page End: 951
• Publication Date: 2014-05
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2014.884490
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>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).</p> </sec> <sec id="ss2"> <title>Methods:</title> <p>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 <sc>am</sc> and 8 <sc>am</sc>, including the commute home) received armodafinil 150 mg or placebo before their night shift.</p> </sec> <sec id="ss3"> <title>Results:</title> <p>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.</p> </sec> <sec id="ss4"> <title>Results:</title> <p>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%, <italic>P</italic> = 0.0017; >9 hours: 77% vs 46%, <italic>P</italic> = 0.0020) regardless of shift duration. Armodafinil patients also demonstrated significantly greater improvements in GAF score (≤9 hours: 9.5 vs 5.4, <italic>P</italic> < 0.0001; >9 hours: 9.6 vs 4.3, <italic>P</italic> = 0.0019) and KSS score (≤9 hours: −2.9 vs −1.9, <italic>P</italic> = 0.0002; >9 hours: −2.8 vs −1.6, <italic>P</italic> = 0.00 28). Improvement in SDS-M composite score was significantly greater for armodafinil patients working >9 hours (−6.8 vs −2.7, <italic>P</italic> = 0.0086). Headache was the most frequent adverse event in all treatment groups.</p> </sec> <sec id="ss5"> <title>Conclusions:</title> <p>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.</p> </sec> </abstract>