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.
The Center for Sleep Medicine , Hattiesburg, MS , USA.
John
J
Harsh
Ronghua
R
Yang
Steven G
SG
Hull
D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000077408:Modafinil; D020178:Sleep Disorders, Circadian Rhythm / Q000188:drug therapy* / Q000209:etiology; D064690:Wakefulness-Promoting Agents / Q000008:administration & dosage*; D014940:Work Schedule Tolerance
D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil