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

Jan 10, 2013
Originally published on January 10, 2013 4:26 pm

The Food and Drug Administration announced Thursday that it was requiring companies that make Ambien and similar sleeping pills to sharply cut the doses of the drugs.

The agency says it is taking the step for the brands Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien, because tests showed the active ingredient in the medications, zolpidem, stays in the body longer than had been thought. That raises the possibility that people taking the drugs will remain drowsy the next day, making activities such as driving and operating heavy machinery dangerous.

"To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe and patients should take the lowest dose capable of treating the patient's insomnia," Ellis Unger, director of the FDA's Center for Drug Evaluation and Research, said in the statement.

The problem is especially a concern for women because the drug tends to stay in their bodies longer than it does in men, the FDA says.

As a result, the FDA is ordering companies to cut the dose for women from 10 milligrams to 5 milligrams for immediate-release products — which include Ambien, Edluar and Zolpimist — and from 12.5 milligrams to 6.25 milligrams for the extended-release product Ambien CR.

In addition, the FDA ordered companies to change the labeling on the drug for men, recommending doctors consider prescribing the same lower doses for them.

"Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate," Unger says.

The move does not affect other popular sleeping pills that contain different active ingredients, such as Lunesta and Sonata. But in an interview with NPR, Unger said the agency is evaluating those as well.

The agency has long known that all these products can leave people drowsy in the morning, says Unger, and there have been about 700 reports of people getting in traffic accidents after taking them.

About 40 million prescriptions for drugs containing zolpidem were dispensed in 2011, making them the most widely used sleeping pills, according to IMS Health, which monitors drug sales.

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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. Transcript provided by NPR, Copyright NPR.