Sleep :: National Sleep Foundation supports FDA’s label request for sleep disorder drugs

The National Sleep Foundation released the following statement regarding the announcement from the U.S. Food and Drug Administration, ?FDA Requests Label Change for All Sleep Disorder Drug Products:?

The National Sleep Foundation (NSF) applauds the U.S. Food and Drug Administration for conducting a post-marketing analysis of adverse reactions that have been reported following use of prescription sleep aids.

NSF feels that broad collection and analysis of such data is an important FDA function, one that ensures understanding of the safe use of prescription and over-the-counter medications.

The FDA identified two types of risks to be addressed with stronger language:

? Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling)
? Complex sleep-related behaviors which may include ?sleep-driving,? preparing and eating food while asleep and making cell phone calls or other behaviors while asleep

On March 8, 2006, NSF issued the following statement on use of sleeping pills approved by the Foundation?s Board of Directors*:

The National Sleep Foundation recommends that when using sleeping pills, as with all medications, individuals follow the instructions provided by their physician and presented in the package insert for that medication. It is important that the patient tell their doctor about any other drugs they are using, including non-prescription medicines and alcohol. If a serious side effect occurs they should immediately report the event to their physician and inquire about stopping the medication. Importantly, NSF encourages those with insomnia and other sleep disorders to decide about appropriate treatment after consulting with their physician or a sleep medicine specialist.

Additionally, and as covered in the March 2006 NSF statement, NSF reiterates that anyone who expects to drive a car or operate equipment should first learn how they respond to a sleep medication and always permit sufficient time for sleep, as indicated in the accompanying information supplied by the manufacturer or pharmacy, before driving or operating the equipment.


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