FDA Says Dangers Of Sleeping Pills Include Driving And Cooking While Asleep

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Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Pharma Industry / Biotech Industry
Article Date: 15 Mar 2007 - 0:00 PDT

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The US Food and Drug Administration (FDA) is asking manufacturers of sedative-hypnotic sleeping pills to warn consumers and health professionals about potential risks like sleep-driving, anaphylaxis, cooking and eating food, and making phone calls while asleep.

The FDA defines sleep-driving as "driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event".

The sleeping pills or sedative-hypnotic drugs affected are:

- Ambien/Ambien CR (Sanofi Aventis)
- Butisol Sodium (Medpointe Pharm HLC)
- Carbrital (Parke-Davis)
- Dalmane (Valeant Pharm)
- Doral (Questcor Pharms)
- Halcion (Pharmacia & Upjohn)
- Lunesta (Sepracor)
- Placidyl (Abbott)
- Prosom (Abbott)
- Restoril (Tyco Healthcare)
- Rozerem (Takeda)
- Seconal (Lilly)
- Sonata (King Pharmaceuticals)

Manufacturers are asked to strengthen the warning on product labels and to send letters to health service providers to tell them about the new warnings. The letters start going out this week.

The FDA summarize the risks as "severe allergic reactions and complex sleep-related behaviours". More specifically they include:

- Anaphylaxis (severe allergic reaction).
- Angioedema (severe facial swelling).
- Sleep-driving.
- Preparing and eating food while asleep.
- Making phone calls while asleep.

Allergic reactions can occur as early as the first time the medication is taken.

Director of FDA's Center for Drug Evaluation and Research, Dr Steven Galson said, "There are a number of prescription sleep aids available that are well- tolerated and effective for many people," but he added that, "After reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks".

As well as strengthening the warnings and sending out announcement letters the FDA has asked manufacturers to write Patient Medication Guides to accompany the drugs when they are dispensed. The Guides will contain FDA approved information about potential risks and explain how to use the drugs correctly, such as abstaining from alcohol and other depressants that affect the central nervous system.

Patients should read the Guides and talk to their doctors if they have any concerns. They should not stop using the medication without talking to their doctor first.

Different sedative-hypnotic products carry different risks and the FDA has asked the drug manufacturers to test the drugs again, this time to find out how often sleep-driving and other complex behaviours arise with each different drug. It is not clear whether this will happen.

Sedative-hypnotic is another term for sleeping pill. These drugs depress the brain and spinal cord (the central nervous system) causing them to slow down, reduce anxiety, and produce a calming and relaxing effect. They also affect thinking, emotions, body movement such as hand-eye coordination, and speech.

Alcohol also depresses the central nervous system, it slows down the brain and breathing, and in this respect is a sedative-hypnotic, which is why it is contra-indicated for this type of medication.

Click here for "Making Sense of Sleeping Pills" (from MIND, UK mental health charity).

Written by: Catharine Paddock
Writer: Medical News Today


Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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