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Don't Lose Sleep Over Ambien Reports: Experts


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Sanofi-Aventis, the French company that makes Ambien, told the New York Times that it has long known that parasomnias are a rare side effect of the drug, and it continues to report such cases. The FDA told the newspaper it is monitoring Ambien's safety record.

In the meantime, a group of U.S. litigants who claim the drug triggered dangerous parasomnias filed a federal class-action lawsuit against Sanofi-Aventis on March 6.

Why might Ambien, which was approved in 1993, be different than the newer sleep medications, Sonata, approved in 2002, and Lunesta, which became available last year?

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Experts said the answer could lie in Ambien's "half-life" -- the amount of time the drug stays active in the brain. "It lingers a shorter time than Lunesta and a longer time than Sonata," Silber said. "So, it may have something to do with that half-life -- the fact that it stays around for three to five hours may be just the length that's needed to do what it does. But we're not entirely sure."

One thing that experts are sure of is that Ambien, like all drugs, must be taken as directed. In many of the reported cases, users had combined the drug with alcohol or other drugs, or taken it too soon before a hazardous activity, such as driving. "People may also be exceeding the [recommended] dose," Thorpy said. "The usual dose is 5 or 10 milligrams, but sometimes people will take 20 milligrams -- that could be a factor."

According to an AASM statement released this week, consumers should read the fine print on package inserts that come with all prescription sleep medications, to familiarize themselves with proper usage plus any potential side effects.

According to Sanofi-Aventis, the most common side effects associated with Ambien include daytime drowsiness, dizziness and difficulty with coordination. Many can be avoiding by proper dosing and avoiding alcohol.

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Copyright © 2006 ScoutNews, LLC. All rights reserved.
Last updated 3/20/2006





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SOURCES: Donna Arand, Ph.D., clinical director, Kettering Sleep Disorders Center, Dayton, Ohio, and spokeswoman, American Academy of Sleep Medicine; Michael Thorpy, M.D., director, Sleep-Wake Disorders Center, Montefiore Medical Center, Bronx, N.Y.; Michael H. Silber, Ph.D., professor, neurology, Mayo Clinic College of Medicine, co-director, Mayo Sleep Disorders Center, and president-elect, American Academy of Sleep Medicine; March 15, 2006, statement, American Academy of Sleep Medicine; March 8, 14, 2006, New York Times, March 14, 2006, Washington Post


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