Women’s health tip: Be cautious regarding dose for sleeping pills

A sleeping woman.

For the sake of women’s health, regulating the dose of medications like sleeping pills is essential. (Photo Credit: CC BY/Aaron Stidwell/Flickr)

Sleeping pills can have unexpected, even dangerous effects, particularly for women. This is why the U.S. Food and Drug Administration recently reduced the dosage of the popular sleep aid Intermezzo, down from the 3.5 milligram dosage previously approved for men to 1.75 milligrams for women. It seems like a simple thing, but when it comes to sleeping pills, this and other cases suggest that female consumers should proceed with caution.

Sleeping pills and women’s health

The majority of sleeping pills on the market are designed to work for a standard eight hour stretch. In exploring whether or not short-acting sleeping pills are a good idea, the FDA uncovered a gender gap. Blood tests revealed that men metabolize drugs more quickly than women. The active ingredient in Intermezzo, zolpidem, is used in many other sleeping pills, including Ambien (on the market in various forms since about 2007).

Considering that it took until just last month for the FDA to reduce the dose in women, it’s clear that not enough caution is taken before such drugs reach the market – their use isn’t fully understood for all people, and so the consumer needs to proceed with caution when it comes to women’s health. Studies indicate that drugs ranging from aspirin to anesthesia can all produce different unintended negative effects in women, directly related to dosage.

“This is not just about Ambien — that’s just the tip of the iceberg,” said Dr. Janine Clayton of the National Institutes of Health. “There are a lot of sex differences for a lot of drugs, some of which are well known and some that are not well recognized.”

The strange restrictions of drug trials and women’s health

It wasn’t until 1993 that women of childbearing age were allowed to participate in new drug trials. The FDA lifted the ban, and researchers quickly pointed out that the landmark studies claiming that aspirin could abate heart attack and stroke had previously only been tested on men. As women began to be tested in various drug trials, the Government Accountability Office notes that 8 of 10 drugs removed from the market from 1997 through 2000 were once that actually posed health risks to women. The antihistamine Seldane was one of these, as was the gastrointestinal drug Propulsid. The New York Times notes that the latter could cause heart arrhythmia in women.

Women’s health – the reasons for sex differences

As women metabolize drugs differently – based largely upon a higher percentage of body fat on average and hormonal fluctuations – there is a higher change that any medicine, sleeping pills or otherwise, will remain in the fatty tissue. This is because many medications are lipophilic, or attracted to fat tissues, notes Dr. Wesley Lindsey of the Pharmacy school at Auburn University. In women, this means that the effect of medications will remain longer, and likely be more pronounced. Until sleeping pills’ or any other drugs’ dosage has been fully screened for women, it pays to play it safe and not operate heavy machinery even an hour or two after the supposed time of effect has passed.


National Institutes of Health

New York Times

U.S. Food and Drug Administration

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