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Wake-Up Call: FDA Pushes Drugmakers To Weaken Sleeping Pills

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Wake-Up Call: FDA Pushes Drugmakers To Weaken Sleeping Pills

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Wake-Up Call: FDA Pushes Drugmakers To Weaken Sleeping Pills

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From NPR News, this is ALL THINGS CONSIDERED. I'm Audie Cornish.


And I'm Melissa Block.

The Food and Drug Administration says people who take some of the most popular sleeping medicines should be taking much lower doses. The FDA points to new research showing that when people get up the next day, the drugs are still in their bodies and they can't drive as safely. Here's NPR's Rob Stein to report on the dangers.

ROB STEIN, BYLINE: The FDA is changing the dose for drugs sold under the brand names Ambien, Zolpimist and Edluar, as well as generic forms of these medications. These are the most widely used insomnia treatments out there. Ellis Unger is an FDA scientist. He says the agency has known for a long time that there can be some dangerous side effects when people are on these drugs to try to sleep.

DR. ELLIS UNGER: We've known for years that all of these drugs sedate. That you should think about driving. You should understand how the drug works in you. You shouldn't operate heavy machinery.

STEIN: And this isn't the first time the agency has issued an alert about these medications. About five years ago, the FDA warned that these medicines can sometimes make people do strange things while they're sleeping.

UNGER: We're talking about cooking or driving or actually having sex while asleep.

STEIN: But now new studies say that these sleep aids can leave people groggy the next day because the medications are still in their bodies after they wake up in the morning.

UNGER: So this for us was a bit of a red flag.

STEIN: And driving tests confirmed that people taking these drugs can be dangerously impaired even after the medications have supposedly worn off.

UNGER: It wasn't until we received the new data where we got the blood levels and the driving simulation studies and we better identified the frequency of next morning impairment.

STEIN: It looks like this is a much bigger problem for women than men. The drugs just seem to hang around a lot longer in their bodies for some reason.

UNGER: The way the drug is metabolized in women is just slightly more slow.

STEIN: So the FDA ordered the companies that make them to cut the doses for women in half. But just to be on the safe side, the FDA is also recommending that doctors prescribe about half the dose for men too. And the worry isn't just for people driving or operating heavy machinery.

UNGER: A patient who is a lifeguard or, you know, runs a daycare and has a room of children, those activities require vigilance also.

STEIN: The FDA's decision came as a surprise to some doctors like Sam Fleishman, president of the American Academy of Sleep Medicine.

DR. SAM FLEISHMAN: It makes us all as providers think about caution before we start prescribing these medications at the doses that we routinely prescribe them.

STEIN: Fleishman says some patients who depend on the drugs to treat their insomnia are likely to get frustrated if the lower dose just doesn't work as well.

FLEISHMAN: Not only does it make them feel fatigued and tired the next day, but it can precipitate other medical problems. If people don't sleep well, sometimes it exacerbates their, for example, migraine headaches or, you know, their pain issues get worse.

STEIN: Some people even end up missing a lot of work. Another worry is that if the lower doses don't work as well, that could leave some people so tired from lack of sleep that they get into car accidents and have other problems.

FLEISHMAN: I am concerned there may be a little bit of a backfire with this report.

STEIN: The FDA stresses that patients should consult with their doctors to make sure they're getting the dose they need to sleep well but wake up alert and ready for the day. Now, the FDA hasn't cut the doses of other popular sleeping pills such as Lunesta and Sonata, but that's only because officials haven't taken a close look at those drugs yet. That's something they're planning to do now. Rob Stein, NPR News.

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