FDA warns of sleeping pill side effects

Harvey Kirk

By Harvey Kirk
Posted March 18, 2007

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The FDA announced that new warnings will be added to Ambien, Lunesta and other popular sleeping pills, containing information about an increased risk of sleep driving and other complex behaviors while asleep.  Potential sleeping pill side effects will also be outlined by drug makers in information guides which will be given to patients when the drugs are prescribed.

>>INFORMATION: Ambien sleeping pill side effects

For several months there have been discussions in the medical and legal communities regarding sleeping pill side effects which could cause individuals to engage in dangerous activities such as driving, eating or cooking while still asleep.  The sleeping pill warning applies to all drugs in the class known as “sedative-hypnotics,” which includes Ambien, Lunesta, Rozerem, Sonata, Seconal, Prosom, Placidyl, Halcion, Doral, Dalmane, Carbrital and Butisol sodium.

Officials at the FDA requested the warning label changes after reviewing data of adverse events reported since the drugs were approved for sale in the United States.  Disturbing sleeping pill side effects could include sleep driving, binge eating, making phone calls, having sex and attempting to cook while asleep, to name a few. 

Stronger warnings and a clear explanation of the potential side effects should reduce the risk of problems.  Many cases of sleepdriving or sleep walking also involve the use of alcohol or other medications.  The guidelines which the FDA is requiring drug makers distribute with the drug will provide clearer warnings that alcohol and certain other medications should not be used at the same time as sleeping pills.

The sleep drug warnings will also include information about rare, but potentially life threatening allergic reactions which could restrict air passages or cause the face to swell up, known as anaphylaxis and angioedema respectively.  These sleeping pill side effects could occur after only one dose.

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