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Title: Armodafinil Improves Chronic Shift-Work Sleep Disorder in Night-Shift Workers: Presented at APA

"Armodafinil Improves Chronic Shift-Work Sleep Disorder in Night-Shift Workers: Presented at APA"

By Danny Kucharsky TORONTO, CANADA -- May 30, 2006 -- Armodafinil significantly improves chronic shift-work sleep disorder according to patients' subjective reports of wakefulness during the night shift and commute home, noted researchers here at the American Psychiatric Association Annual Meeting (APA). An improvement in wakefulness was associated with reductions in mistakes, near misses, or accidents on the night shift and commute home, as well as reductions in unintended sleep episodes, naps, and caffeine use, according to the study, which was presented by investigator Alan Lankford, PhD, cofounder and administrative director, Sleep Disorders Center, Atlanta, Georgia. The 12-week, double-blind, multicenter study evaluated the effects of armodafinil 150 mg versus placebo on excessive sleepiness in night-shift workers with shift-work sleep disorder. Dr. Lankford noted that modafinil, a wake-promoting agent, has been shown to improve wakefulness in patients with excessive sleepiness. Armodafinil, the R-enantiomer of modafinil, reaches higher concentrations later in the working day compared with modafinil on a milligram-to-milligram basis. The study randomized 254 night-shift workers, of whom 216 were evaluable for efficacy (armodafinil n = 112 and placebo n = 104). Workers completed daily electronic diaries, and recorded sleepiness, number of mistakes, near misses or accidents, and caffeine use during the night shift and on the commute home. The study found that armodafinil reduced the mean number of unintended sleep episodes by 71.8% and naps by 35.8% compared with respective placebo reductions of 42.2% and 13.2% ([P <.05) during the night shift and commute home.

Wakefulness (decrease in maximum level of sleepiness from baseline) during the night shift improved by 2.0 points in armodafinil versus 1.1 points for placebo in patients' subjective reports (P <.0001) and improved on the commute home (decrease of sleepiness from baseline: 1.2 vs 0.6 points; P =.0027).

During the night shift, armodafinil significantly reduced the number of mistakes, near misses, or accidents compared with placebo (P <.05), Dr. Lankford said. During the commute home, armodafinil reduced the number of mistakes, near misses, or accidents (-65.8% vs -46.8%), but the difference was not statistically significant compared with placebo (P >.05).

Armodafinil reduced the number of caffeinated drinks from baseline (mean change -04 ą 0.7), but there was no change from baseline in the placebo group (mean change, 0 ą1.4).

The most common adverse events for armodafinil and placebo were headache (12% vs 10%), nausea (7% vs 3%), nasopharyngitis (6% vs 3%), and anxiety (5% vs 2%). Armodafinil "was fairly well tolerated and the side effects were typical," Dr. Lankford said.

Overall, the effects of the drug were similar to those seen with modafinil in patients with shift-work sleep disorder.

Although shift-work sleep disorder is associated with insomnia during the day, this study did not measure changes in insomnia, Dr. Lankford noted.

Dr. Lankford pointed out that about 15 million Americans work alternative shifts on a regular or rotating basis, and that shift-work sleep disorder is estimated to affect up to 32% of shift workers.

This study was sponsored by Cephalon.

[Presentation title: Armodafinil Reduces Sleepiness in Chronic Shift Work Sleep Disorder. Abstract NR818]

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