The Food and Drug Administration made an announcement that got a lot of attention. According to a “60 Minutes” segment that aired Sunday, the agency cut the recommended dose of the most popular sleep drug in the country in half for women. Scientists have discovered that men and women metabolize Ambien, known generically as Zolpidem, vastly differently, and the FDA has known about it a long time.
Before the dosage adjustment, women were left with more of the drug in their bodies the next morning after taking the drug the previous evening, leaving them at a much greater risk of impaired driving.
“So if I took Zolpidem, and my brother took same dose, probably the maximum level of drug in my blood would be 45 percent higher than his maximum blood level,” Dr. Sandra Kweder, deputy director of the FDA’s office of new drugs, told Leslie Stahl of “60 Minutes.” The piece goes on to question how millions of women were being “overdosed” on Ambien since its creation two decades ago.
Ambien is currently the only prescription drug in the country with a different suggested dose for men and women, according to the segment. But there seem to be a broad spectrum of drugs that should be more closely examined in how they are prescribed, scientists interviewed for the piece said, even aspirin.
And the problems with research and development of new drugs have been sourced to male-only models in animal-testing studies. According to Dr. Melina Kibbe in the segment, out of more than 1,000 lab studies done for new drugs on animals, only 3 percent were mixed gendered. Further, approximately 34 percent didn’t reveal what gender the study included at all.
Controversies have plagued the FDA and new drugs for decades.
As the HIV/AIDs epidemic spiked in the mid 1980s, drug treatment options were a highly contentious issue, with azidothymidine, or AZT for short, taking center stage. It was later revealed high dosages AZT were harmful to patients. The FDA later made the adjustments, but not after much dispute in medical, patient and legal circles.
More recently, anti-obesity drugs Belviq (lorcaserin) and Qsymia (phentermine plus topiramate) have been approved for use in the U.S., but are banned in Europe. The so-called diet drugs have been “deemed too harmful for any weight-loss benefits to be worthwhile — the ratio of their risks to benefits is too high, according to the European Medicines Agency,” an article noted in August.
The “60 Minutes” piece, which centers on female differences in drug dosages, noted that there is just as much harm for men as women in such a flawed research-and-approval system.
“If you’re clumping men and women together in your study, and there truly is a sex difference, you’re not just harming the women; you’re harming the men,” Larry Cahill, a neuroscientist at the University of California Irvine, told Stahl. “You’re muddling up the understanding of what’s going on, you’re muddling up the path to clear treatment, not just for the women, but for the men as well.”
It’s not just differences in drug dosages either. Drugs are apparently just the beginning. Gender distinctions have been found in pain receptors, liver enzymes and how the brain is wired.