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Sleeping pill dosages and drowsy driving accidents

Jan 10, 2013 - Car Accidents by

As we discussed in last week’s post, sleep deprivation is a major problem on America’s roads. From North Carolina to North Dakota, and in every other state, the number of people who drive without getting enough sleep is frightening – and the risk of car accidents caused by them is disturbingly real.

Today, an announcement by the Food and Drug Administration was another reminder of how serious the problem is. The FDA is requiring manufacturers of popular sleeping pills to reduce the recommended dosage for women by half. The reason is that several studies have shown that using the pills at current recommended dosages can leave those who take them sleepy in the morning – and therefore at elevated risk of drowsy driving accidents.

Why do the new recommendations apply to women but not to men? The answer lies in different body chemistries between the two genders. A chemical ingredient called zolpidem tends to stay in women’s bodies longer than men’s. And zolpidem is the most widely used aid for helping people sleep.

The FDA requirement on recommended dosage of pills that contain zolpidem applies to popular name brands of sleeping pills. These include Ambien and Zolpimist, among others.

How large are the doses involved? The FDA is directing that the recommended dosages for women be cut from 10 milligrams to 5 milligrams for immediate-release sleeping aids, including Ambien, Zolpimist and Edluar. For the extended-release products, recommended dosages for women are also to be cut in half, from 12.5 milligrams to 6.25.

The FDA is not ignoring men entirely in this safety initiative. The agency has told drug manufacturers that even for men, healthcare providers should consider whether lower doses would be preferable.

Source: “F.D.A. Requires Cuts to Dosages of Sleep Drugs,” The New York Times, Sabrina Tavernise, 1-10-13

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