Supplement toAvailable at jfponline.<strong>com</strong>Vol 59, No 1 / January 2010Shift-work disorder
Armodafinil for Treatment of Excessive Sleepiness Associated With Shift Work Disorder: A Randomized Controlled StudyJournal List > Mayo Clin Proc > v.84(11); Nov 2009Mayo Clin Proc. 2009 November; 84(11): 958–972.Copyright © 2009 Mayo Foundation for Medical Education and ResearchArmodafinil for Treatment of Excessive Sleepiness Associated With Shift Work Disorder: A Randomized Controlled StudyFormats: Abstract| Full Text| PDF (1.2M)PMCID: PMC2770907PubMed articles by these authors● Czeisler, C.● Walsh, J.Charles A. Czeisler, PhD, MD, James K. Walsh, PhD, Keith A. Wesnes, PhD, Sanjay Arora, PhD, † and Thomas Roth, PhDFrom the Division of Sleep Medicine, Harvard Medical School, and Division of Sleep Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (C.A.C.); Sleep Medicine and Research Center, St Luke's Hospital, Chesterfield, MO (J.K.W.); Cognitive Drug Research Ltd, Goring-on-Thames, UK (K.A.W.); Sleep Disorders andResearch Center, Henry Ford Hospital, Detroit, MI (T.R.). The participating investigators are listed on page 969† Died March 1, 2007; was an employee of Cephalon Inc.Individual reprints of this article are not available. Address correspondence to Charles A. Czeisler, PhD, MD, Division of Sleep Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Ave, Ste 438A, Boston, MA 02115 (; Email: charles_czeisler/at/hms.harvard.edu).This article is freely available on publication, because the authors have chosen the immediate access option, which is funded by Cephalon.●See "Fatigue, Countermeasures, and Performance Enhancement in Resident Physicians" on page 955.Other Sections▼AbstractOBJECTIVE: To assess the effect of armodafinil, 150 mg, on the physiologic propensity for sleep and cognitive performance during usual night shift hours in patients with excessive sleepiness associated with chronic (≥3 months) shift work disorder (SWD) of moderate or greaterseverity.PATIENTS AND METHODS: This 12-week, randomized controlled study was conducted at 42 sleep research facilities in North America from April 2 through December 23, 2004, and enrolled 254 permanent or rotating night shift workers with SWD. Entry criteria included excessivesleepiness during usual night shifts for 3 months or longer (corroborated by mean sleep latency of ≤6 minutes on a Multiple Sleep Latency Test), insomnia (sleep efficiency ≤87.5% during daytime sleep), and SWD that was judged clinically to be of moderate or greater severity.Patients received armodafinil, 150 mg, or placebo 30 to 60 minutes before each night shift. Physiologic sleep propensity during night shift hours, clinical impression of severity, patient-reported sleepiness, and cognitive function were assessed during laboratory night shifts at weeks4, 8, and 12.RESULTS: Armodafinil significantly improved mean (SD) sleep latency from 2.3 (1.6) minutes at baseline to 5.3 (5.0) minutes at final visit, <strong>com</strong>pared with a change from 2.4 (1.6) minutes to 2.8 (2.9) minutes in the placebo group (P
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