Reuters: FDA calls for stronger warnings on sleep drugs

[Eugene]

FDA calls for stronger warnings on sleep drugs

By Susan Heavey

1 hour, 29 minutes ago

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Wednesday
ordered sleep disorder drugs to carry stronger warnings about their risks, such as
drowsy driving and severe allergic reactions.

The warning, which applies to prescription sedative-hypnotic medications, targets
13 drugs such as Sepracor Inc.'s Lunesta and Sanofi-Aventis's Ambien, the agency
said.

Dr. Steven Galson, head of FDA's Center for Drug Evaluation and Research, said
many of the drugs can be used safely but post-marketing data pointed to some
concerns.

-snip-

Those risks can include doing various activities such as driving, eating and
talking while asleep without any recollection afterward, the FDA said. Severe
allergic reaction known as anaphylaxis, and severe facial swelling, or angioedema,
can also occur, even with the first dose.

-snip-

Full article: http://news.yahoo.com/s/nm/20070314/us_nm/drugs_sleep_dc

[noonwitch]

1. I guess they will have to put the warning in three inch high letters on each bottle

Really, though, how stupid must someone be to not realize that a sleep aid will make you drowsy enough that you really shouldn't drive anywhere.

[Eugene]

2. Ambien user have been known to get up and drive in their sleep.

They don't know they are driving. That's the problem.

[pnwmom]

3. You don't understand. A person takes the sleep aid and goes

to bed.

Then, a few hours later, he partially rouses -- or actually, sleepwalks -- and still under the influence of the Ambien, still unconscious, manages to do things like drive a car, open a locked door, operate a microwave, eat food, use the telephone, etc.

In my mother's case, thankfully, all she did was use the telephone and call us at 3 or 4 a.m. But she was completely disoriented and wasn't talking sense. It was scary for us until we put 2 and 2 together about the sleep aid. As soon as she stopped it, so did her crazy behavior.

[DeepModem Mom]

4. NYT, pg1: F.D.A. Warns of Sleeping Pills’ Strange Effects

F.D.A. Warns of Sleeping Pills’ Strange Effects
By STEPHANIE SAUL
Published: March 15, 2007

The most widely prescribed sleeping pills can cause strange behavior like driving and eating while asleep, the Food and Drug Administration said yesterday, announcing that strong new warnings will be placed on the labels of 13 drugs.

The agency also ordered the makers of the well-known drugs Ambien and Lunesta and the producers of 11 other commonly used sleeping pills to create patient fliers explaining how to use them safely.

The fliers, which the agency says it requires when it sees a significant public health concern, will be handed out at pharmacies when consumers fill their prescriptions.

Although the agency says that problems with the drugs are rare, reports of the unusual side effects have grown as use of sleeping pills has increased.

Sales in the United States of Ambien and Lunesta alone last year exceeded $3 billion. Use of those medications and other similar drugs has soared by more than 60 percent since 2000, fueled by television, print and other advertising. Last year, makers of sleeping pills spent more than $600 million on advertising aimed at consumers....

http://www.nytimes.com/2007/03/15/business/15drug.ready.html?ref=todayspaper

[ceile]

5. Shocker!

People are so stressed out these days that they'll try anything to forget and have a good nights sleep.
Oh, and Ambien was created by the Devil. Felt like I was having a bad acid trip.

[yardwork]

6. Ambien seems to be involved in a lot of suicides

That's my gut feeling, based on anecdotal evidence. I think that it is a very dangerous drug, and I suspect that one day we'll learn that the manufacturers have suppressed a fair amount of info on the side effects.

[0rganism]

7. but isn't it great that the feds can prosecute terminally-ill marijuana smokers?

Sure, let's all go buy us some well-advertised freakout pills, just don't be caught with that wacky tobacky.