Rozerem Information - August 28, 2008

FDA Warns Sleeping Pills Can Cause Sleep-Driving

March 14, 2007 - Topics sleep, fda, prescription, alcohol and rozerem
The Food and Drug Administration (FDA) on Wednesday warned that sleeping pills may sometimes cause sleep-driving, a hazardous condition similar to sleep-walking where sleep-drivers may actually drive their cars and cause severe auto accidents yet have no recollection of the events.

The condition is common in people who take sleeping pills and other sedative-hypnotic drugs indicated to induce or maintain sleep. The FDA has now asked the manufacturers of these drugs to include strong language in their product labeling to warn about sleep driving, as well as other potential risks.

The FDA has reportedly compiled more than a dozen reports of sleep-walking and more are expected to pour in now. The most widely covered case of sleep-driving occurred almost a year ago when Rep. Patrick Kennedy crashed his car after taking Ambien. The Congressman said he had no memory of the event but pleaded guilty to driving under the influence of prescription drugs. He was sentenced to court-ordered drug treatment and a year's probation

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New Sleeping Pill Unlikely To Be Abused

October 12, 2006 - Topics abuse, sleep, ramelteon, rozerem and research
esearchers note that a new medication, Rozerem (known generically as ramelteon), recently approved for insomnia treatment does not appear to have any characteristics that might lead to dependence or abuse.

The sleep aid acts in the same way as melatonin, the natural hormone that has been linked to healthy sleep in numerous studies, with Dr. Roland R. Griffiths telling Reuters Health,, "Our study found no evidence of potential for abuse or impairing effects of ramelteon up to 20 times the recommended therapeutic dose

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New Sleep Drug May Cause Fewer Side Effects

October 5, 2006 - Topics sleep, prescription, ramelteon, rozerem and abuse
A newly approved sleep medication does not seem to have side effects common to benzodiazepine receptor agonists, the leading prescription drugs to treat insomnia. Benzodiazepines - which include Valium, Xanax and Halcion - carry a risk of abuse, addiction and motor or cognitive impairment. However, it appears the new drug, ramelteon, does not cause these problems.

Benzodiazepines can impair thinking, learning and memory and cause motor impairments that can make driving dangerous or cause older adults to fall. Long-term users can have unpleasant withdrawal symptoms when they stop taking the drug, like anxiety, irritability and even seizures

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FDA Approves Non-Addictive Sleep Aid

August 4, 2005 - Topics fda, sleep, food, prescription and rozerem
A new insomnia drug, Rozerem, has been approved by The Food and Drug Administration, becoming the first drug of its kind not to be classified as a controlled substance.

Because of its non-addictive classification, reports WCVB-TV in Boston, Rozerem can be used for long-term use

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