OBJECTIVE: 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 (> or =3 months) 
shift work disorder (SWD) of moderate or greater severity.
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 excessive sleepiness during usual night shifts for 3 months or 
longer (corroborated by mean sleep latency of < or =6 minutes on a Multiple 
Sleep Latency Test), insomnia (sleep efficiency < or =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 weeks 4, 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, compared with a 
change from 2.4 (1.6) minutes to 2.8 (2.9) minutes in the placebo group 
(P<.001). Clinical condition ratings improved in more patients receiving 
armodafinil (79%) vs placebo (59%) (P=.001). As reported by patients' diaries, 
armodafinil significantly reduced sleepiness during laboratory nights (P<.001), 
night shifts at work (P<.001), and the commute home (P=.003). Armodafinil 
improved performance on standardized memory (P<.001) and attention (power, 
P=.001; continuity, P<.001) tests compared with placebo. Armodafinil was well 
tolerated and did not affect daytime sleep, as measured by polysomnography.
CONCLUSION: In patients with excessive sleepiness associated with chronic SWD of 
moderate or greater severity, armodafinil significantly improved wakefulness 
during scheduled night work, raising mean nighttime sleep latency above the 
level considered to indicate severe sleepiness during the daytime. Armodafinil 
also significantly improved measures of overall clinical condition, long-term 
memory, and attention.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00080288.