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Warnings for Sleeping Pills

Posted on April 29, 2008

There are now stronger warnings on the possible risks of taking drugs to treat sleep disorders - drugs such as Ambien (zolpidem tartrate), Lunesta (eszopiclone) and Restoril (temazepam). FDA is asking all manufacturers of sedative-hypnotic drugs to strengthen the language in the product labeling about two issues: severe allergic reactions, and unusual behavior in patients who take these products.

The warnings will point out that anaphylaxis and angioedema have been reported in patients as early as the first time the drugs are taken. In addition, the label will warn that patients on these drugs have engaged in certain behaviors after having gone to sleep, such as driving or eating, often with no recollection of the event.

Although all sedative-hypnotic drugs have these risks, there may be differences among these products in how often they occur. Because of this, FDA is recommending that the drug makers conduct clinical studies to investigate how often sleep-driving and other unusual behaviors occur with their products.

The manufacturers will also be developing Medication Guides to be given to patients whenever the drug is dispensed. The guide will explain the drug's proper use, its risks, and precautions patients should take while using it. This includes avoiding alcohol and other central nervous system depressants because they can increase the risk of sleep-driving and other unusual behaviors.

Sleep Disorder (Sedative-Hypnotic) Drugs:

• Ambien, Ambien CR (zolpidem tartrate)
• Butisol sodium
• Carbrital (pentobarbital and carbromal)
• Dalmane (flurazepam hydrochloride)
• Doral (quazepam)
• Halcion (triazolam)
• Lunesta (eszopiclone)
• Placidyl (ethchlorvynol)
• Prosom (estazolam)
• Restoril (temazepam)
• Rozerem (ramelteon)
• Seconal (secobarbital sodium)
• Sonata (zaleplon)

Additional Information:

FDA MedWatch Safety Alert. Sedative-hypnotic drug products. March 14, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative

FDA Office of Women's Health. Sleep Disorders. 2006.
http://www.fda.gov/womens/getthefacts/sleep.html

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