FDA Says Patients Need to Cut Dose of Sleeping Pills

People who take medication to help them get to sleep and stay asleep have always been cautioned about its potential for addiction and side effects ranging from the minor to the serious. Last week, the FDA deemed one class of this medication so dangerous that it’s requiring manufacturers to reduce its dosage.

As reported on NPR, Ambien, its generic versions and similar sleeping pills (AmbienCR, Edluar and Zolpimist) must reduce the amount of their active ingredient, zolpidem, because it remains in the body longer than had been thought. That means people who take a pill to sleep might be dangerously drowsy the next day.

Side effects of sleeping drugs range from headaches, dry mouth and constipation to trouble concentrating, dizziness and rebound insomnia. That’s when you stop taking a drug and the problem you originally took it to address returns, only worse.

Daytime sleepiness has long been a sleeping pill hazard, and, it turns out, Ambien and its fellow pharmaceutical travelers, carry an extreme risk, to the point of making driving and operating machinery hazardous. The FDA has gotten about 700 reports of people getting in traffic accidents after taking these drugs.

The concern is most acute for women, because the drug stays in their bodies longer than it does in men.

The FDA has required the dose for women to be reduced by half–from 10 milligrams to 5 milligrams for immediate-release products (Ambien, Edluar and Zolpimist), and from 12.5 milligrams to 6.25 milligrams for Ambien CR, an extended release pill.

Manufacturers also must change the products’ labels on the drug for men, for whom FDA also has recommended lower doses.

Ellis Unger, director of the FDA’s Drug Evaluation and Research, said “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 told NPR that although other popular sleeping pills, including Lunesta and Sonata, have different active ingredients and are not subject to the warning and reduced dosage, the FDA is looking at their safety as well.

The New York Times reported that in 2011 about 60 million prescriptions for sleeping medication were dispensed; about 40 million were drugs containing zolpidem.

In addition to the common side effects, The Times noted some other strange behavior attributed to the drugs–texting, eating or having sex during the night without any memory of it in the morning.

Some people who are dependent on sleeping medication may have difficult tapering off of it. If you take a zolpidem drug, FDA officials recommend continue doing so for now, but talk to your doctor about altering the dose. Doctors will still be able to prescribe the higher dosage, according to The Times, if the lower dose does not work.

The FDA has a list of questions and answers for patients about Ambien and other drugs including how to treat insomnia, what are the over-the-counter options, what are the effects of other classes of sleeping pills and how to decrease your risk of next-day drowsiness if you take sleeping pills. Link here for the complete discussion.

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