Parker, Waichman, Alonso LLP

Home » Articles

FDA Demands Stronger Warnings for Sleep Meds

Mar 14, 2007 | CNN

LEMON: Well, the government wants new warning labels on a type of sleeping pill you've probably seen a lot of ads for or even use yourself. The drugs have been linked to sleep walking and even sleep driving in some cases. Our medical correspondent, Judy Fortin, is with us now, and she's going to tell us all about this. Wow.

JUDY FORTIN, CNN CORRESPONDENT: Yes, Don. We want to be clear. We're talking about prescription sedatives, and the Food and Drug Administration today is asking manufacturers of these prescription sleep disorder medications to strengthen the label information about potential risks.

And here's what we're talking about: risks like severe allergic reactions, severe facial swelling, and something that the FDA is calling complex sleep-related behaviors. You probably heard about these, like sleep driving, making phone calls, and preparing and eating food while asleep with apparently no memory of the events afterwards, something very frightening for people.

LEMON: I imagine that would be frightening. Obviously, there's a warning going out, a number of cases. How many cases are we talking about?

FORTIN: Well, the FDA won't say exactly. And that's the big problem. They say there have been rare but adverse events reported. And the agency is concerned about underreporting, people who don't want to admit or may be embarrassed by the fact that these things have happened. People who may be sleep eating, going into their kitchen and making full meals and then not wanting to tell people about it afterwards.

LEMON: All right. Let's talk about which drugs. Which drugs are targeted for this new labeling?

FORTIN: Well, there's specifically 13 prescription medications affected. For the full list, we want to tell people they can go to CNN.com or CNN.com/health. But I'll name a couple of them for you right now. We're talking about Ambien, Lunesta, Halcion and Rozerem.

The FDA has also requested manufacturers send letters to doctors notifying them of the new warnings. And companies must also develop something called a patient medication guide that will be distributed with the prescriptions.

LEMON: All those you mentioned are very popular drugs.

FORTIN: Sure.

LEMON: We see those ads for them all the time.

FORTIN: They're blockbusters.

LEMON: OK. So is this most drugs have warnings anyway. Is this going to go beyond the typical instructions handed out?

FORTIN: Well, presumably they will. You usually get some sort of a guide to your prescription medication anyway.

LEMON: Right.

FORTIN: The FDA is asking the manufacturers to go one step further. They're saying make this easy to understand, simple language. Make sure that the people understand the risks that are associated with the drugs.

We talked about driving under the influence of some of these drugs. That would be something like that. Making sure that you're not drinking alcohol or using central nervous system depressants at the same time. This is actual video of an example of someone who was under the influence of one of these sedatives and was caught on camera by police.

Now the FDA is asking that the guides be given not just to patients and I think this is interesting, Don. But they also want family members and care givers to get these guides so they can recognize some of this unusual behavior and make sure precautions are taken.

LEMON: That's amazing. Can we get that video back up? Because it looks like this person had been it looks like a sobriety test.

FORTIN: It does. Like they're weaving. And very often they don't remember these types of incidents.

So we want to mention one more thing, too. That not all of these drugs carry the same risks.

LEMON: OK.

FORTIN: And that's something the FDA wants drug manufacturers to look into. They want them to go back and do actual clinical trials. That's something that's actually done before these drugs are ever distributed to the public.

But they want them to do it again and make sure that, if there are any of these problems, with the sleep driving, the sleep eating, of course the more serious medical problems with the allergies, the allergic reaction and the facial swelling, that they know what risks are associated with these individual products.

LEMON: And Judy, thank you for this, because this is so important. A lot of people take these. I've even taken sleeping pills.