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Cephalon Submits NUVIGIL Supplemental New Drug Application For The Treatment Of Excessive Sleepiness Associated With Jet Lag Disorder
Cephalon, Inc. (Nasdaq: CEPH) announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Jet lag disorder is an acute condition that occurs when a person"s internal body clock becomes disrupted as a result of rapid travel across several time zones. Based on U.S. Bureau of Labor Statistics findings, an estimated 70 million American travelers experience jet lag annually. Currently, there are no FDA-approved medications to improve wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights.
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Unique Study Into Health And Wellbeing Of Older People
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Less Sleep Associated With High, Worsening Blood Pressure In Middle Age
Middle-aged adults who sleep fewer hours appear more likely to have high blood pressure and to experience adverse changes in blood pressure over time, according to a report in the June 8 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
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In Men, Insomnia With Objective Short Sleep Duration Is Associated With Increased Mortality

Men with insomnia and sleep duration of six or fewer hours of nightly sleep are at an increased risk for mortality, according to a research abstract presented on June 8, at SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies Results indicate that compared to people who sleep six hours or more, men with insomnia and less than six hours of nightly sleep were at highest risk of mortality. The mortality rate of the sample was 19.6 percent for men versus 10.3 percent for women. The study included data from 1,741 men and women who were randomly selected from Central Pennsylvania. Participants were studied in a sleep laboratory; follow-ups were conducted over the course of 14 years for men and 10 years for women. Insomnia was defined by a complaint of insomnia with duration of greater than a year, while "poor sleep" was defined as a complaint of difficulty falling asleep, staying asleep or early final awakening. Polysomnographic sleep duration was classified into two categories; people who slept greater than six hours, and those who slept for less than six hours. According to the lead author, Alexandros Vgontzas, MD, endowed chair in Sleep Disorders Medicine at Penn State College of Medicine in Hershey, PA., insomnia is associated with medical morbidity and mortality rates similar to those seen in patients with obstructive sleep apnea. "Based on clinical experience and pervious studies, we can speculate that medication and cognitive behavioral therapy (CBT) or a combination of the two can be used to extend sleep duration and reduce the risk of mortality," said Vgontzas. Other studies have also found serious medical risks associated with insomnia and objective short sleep duration; another study led by Vgontzas presented at SLEEP 2009 found that insomnia with objective short sleep duration is also associated with increased risk of diabetes. Authors of the study claim that findings indicate that people with insomnia should seek evaluation and treatment from their medical provider. Although the results suggest that people with insomnia have a lower risk for physical problems if their sleep duration is normal, they still are at increased risk for depression and may suffer from the behavioral effects of insomnia. Abstract Title: Insomnia with objective short sleep duration is associated with increased mortality in men Presentation Date: Monday, June 8 Category: Sleep Disorders - Insomnia Abstract ID: 0868 Kelly Wagner American Academy of Sleep Medicine


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