20 Years Later, Drugs Do Act Differently in Women
Mar 31, 2014: By: Applied Clinical Trials Online: Lisa Henderson
In January 2013, FDA told manufacturers to lower the dose of zolpidem for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). That was based on evidence the drug is metabolized more slowly in women, which makes the side effect of next-day impairment more likely in women than men.
Ambien was approved 20 years ago, at a time when researchers evaluated drugs differently for men and women. Different in that there was a fundamental belief the only difference between the sexes was the reproductive system. In a recent broadcast from 60 Minutes on gender differences in drugs, Larry Cahill, a neuroscientist at the University of California Irvine, said he “used to share his field’s assumption that males and females outside the reproductive system were fundamentally the same.” But he’s changed his outlook, in part due to the Ambien difference in metabolism by gender, which becomes a textbook case of the incorrectness of that thinking. He says, basically, that for 20 years, women have been overdosing on Ambien.
To be sure, for many years, the call for more adequate population representation in clinical trials is often made. Minorities are under-represented in clinical trials—Hispanics account for only 7.6% and African-Americans 15%, according to the NIH. And even older persons may be excluded from clinical trials. Read More
