NUVIGIL Jet Lag Disorder Data Presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep...(sing two measures: an objective assessme...),Health

The data showed NUVIGIL significantly improved wakefulness in the participants, as assessed by the MSLT averaged across days one and two. Participants taking NUVIGIL 150mg/day had an average time to fall asleep of 11.7 minutes, compared to 4.8 minutes for subjects taking placebo and 7.7 minutes for subjects taking NUVIGIL 50mg/day (p<0.0001 for both doses compared with placebo). An average time to fall asleep of less than 5 minutes on the MSLT is considered pathological sleepiness and an average time to fall asleep of greater than 10 minutes is considered within the normal range.

Researchers also found that NUVIGIL 150mg/day significantly improved patient-reported clinical condition, as assessed by the mean PGI-S [rating 1=normal to 7=extremely ill], averaged across days one and two, compared with placebo (1.6 armodafinil 150mg/day versus 1.9 placebo; p=0.04). NUVIGIL was generally well-tolerated in the study. The adverse events reported in this study are consistent with the current NUVIGIL label. The most common adverse events observed more frequently with NUVIGIL use compared to placebo (greater than or equal to five percent), included headache, nausea, diarrhea and palpitations.

"Following travel across multiple time zones, many travelers can schedule their meetings or activities to take place after their bodies have adjusted to the local time zone. Others may not have these options and must conduct their daily activities while functionally impaired and excessively sleepy due to the time zone change," said Dr. Richard Bogan, Primary Investigator for the study, Chief Medical Officer of Sleep Med Inc., and Clinical Associate Professor of Medicine, University of South Carolina School of Medicine. "We now have data that show NUVIGIL can pl
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