If you watched 60 Minutes the other night you would have seen a fascinating story titled “Sex Matters: Drugs Can Affect Sexes Differently.” Lesley Stahl challenged the FDA on its traditional policy of treating men and women the same when it comes to doses of medication.
The primary example was the sleeping pill Ambien (zolpidem). When the drug was reviewed by the FDA over 20 years ago during the approval process, a reviewer at the agency noted, “The results suggest a gender-related difference.” In fact, women were in general more susceptible to the drug than men. Their blood levels were 45% higher than those of their male counterparts. That means they were getting more of the medicine and in many cases receiving an overdose.
Although Ambien was approved by the FDA in 1992, it wasn’t until Jan 10, 2013, that the agency announced that women should avoid the standard 10 mg dose and instead switch to half as much, or 5 mg of the active ingredient zolpidem. The fear was that higher blood levels would persist longer in the body, leading to a morning hangover effect, slower reaction times and potential traffic accidents among women who had to drive the morning after taking Ambien.
There is also a slow-release 12.5 mg formulation of Ambien. The FDA cautioned women to switch to the 6.25 mg formula.
When you view the 60 minutes interview, you will see tough questions from Leslie Stahl. For example, what took the FDA so long to recognize there was a problem if the agency knew about the gender difference back in 1992? The answer was basically that the FDA didn’t believe gender differences really mattered clinically. Dr. Sandra Kweder of the FDA said…”this was sort of business as usual for what you saw in clinical pharmacology studies.” In other words, if the FDA even noted a difference between men and women, it was disregarded.
To date, the only medication for which the FDA has made a clear distinction between dosing for men and women is Ambien. Now that the FDA has acknowledged that there can be significant differences in dosing requirements for men and women, the agency is on the horns of a giant dilemma. Here is an interchange between 60 Minute’s Leslie Stahl and the FDA’s Sandra Kweder, MD:
“Lesley Stahl: There are scientists who say the Ambien situation is like a wakeup call. It’s a tip of the iceberg. So, should the FDA go back and look at other drugs?
Dr. Sandra Kweder: Well, you know, to say every drug– every drug, go back and look again?
Lesley Stahl: Yeah.
Dr. Sandra Kweder: That’s an enormous undertaking.
Lesley Stahl: So can women feel secure that the dosages recommended on any of their medications is proper for them? Or should they now be a little worried?
Dr. Sandra Kweder: In medical practice, there is a general awareness that there may be individual differences among patients. And that every patient needs to have the right dose.
Lesley Stahl: How’s a doctor supposed to know?
Dr. Sandra Kweder: You start at the lowest dose, and you see if it’s enough.
Lesley Stahl: Yeah, but you’re doing the studies. And they’re gonna rely on your recommendation.
Dr. Sandra Kweder: Yup.
Lesley Stahl: It sounds like the FDA is being more reactive than aggressive about this.
Dr. Sandra Kweder: I think we’re being very aggressive about bringing the most sophisticated science to new drugs and being aggressive about applying the science where we have reason to believe there is a concern to older drugs.
Lesley Stahl: The FDA told us it is looking at other sleep drugs for possible sex differences, but not mounting an across the board review. As of today, zolpidem remains the only drug on the market with different recommended doses for men and women.”
What this means is that there are hundreds, perhaps thousands of medications that have never been studied for sex differences. Doctors are flying blind when they prescribe a medication to a woman, since many of the clinical trials relied primarily on young healthy men for data. Starting with “the lowest dose” may not be helpful if there is only one dose or if the FDA’s dosing recommendations are tailored to men.
What’s a Woman to Do?
Always ask the prescribing physician about personalized dosing recommendations that might be more appropriate for women than men. Mention the 60 Minutes segment and the Ambien example.
Pay attention to your body. If you think you are getting an overdose and experiencing symptoms, bring it to the doctor’s attention immediately.
Report your own experience below in the comment section so other women can read about your story. If more women share stories, health professionals (and the FDA) may take notice.
Learn more about the changed dose of Ambien at this link.
Here are a few stories about Ambien to give you an example of what we are talking about:
“I had bad effects from Ambien. I stayed groggy almost all day, and found that I was quite depressed. It was very difficult withdrawing from the medication, but I decided that being tired was better than being so groggy. I often stay awake for hours, and get up and read, play solitaire, or just daydream. Ambien was not a good drug for me.”
“Ambien is one of the scariest drugs on the market. I say this, after seeing two people very close to me do crazy things while on the drug and then go back to sleep and not remember anything that they did.
“My mother found herself in her nightgown, standing in a line at a Subway, ordering a sub and not knowing how she got there. My friend’s daughter woke up, went into the garage and got in the family car, and backed out without opening the garage door. After knocking the garage door off of its tracks, she got out of the car, went back to bed and doesn’t remember a thing.
“Truly a scary drug because of the ease at which a doctor will prescribe it because it is non-habit forming and telling their patients that it is relatively safe.”
“I’ve been taking Ambien every night for around nine years. I take one half of a 5mg pill at bedtime. It seems to calm a mild anxiety I’ve had for years and I sleep for 2 hours, usually, when I get up to go to the bathroom. Often I will take the second half pill then, or depending on how sleepy I feel, many nights I don’t take the second half. Together, they usually give me 7-8 hours sleep, which works for me.
“When I was prescribed the extended release version and took one dose, I had the only hallucination I’ve ever experienced. I threw that batch away without taking a second dose.”
“I briefly took Ambien for insomnia. I began noticing that I could not remember students’ names. (These were children I had taught for several years!) The final straw was when I woke up and realized I had driven my car to a local store and purchased items. I was getting ready to go to the store to buy these items and found they had already been purchased by me in an Ambien blackout.
“No more Ambien for me! Has anyone else started to forget words for common items or names of people they know? My memory came back completely once I threw the remaining pills out.”
“I’ve taken Ambien for five years. I only take 5 mg and sometimes split them in two. No problems. Just peaceful sleep.”
Many women have commented that 10 mg works fine for them and produces no noticeable side effects or morning hangover. Others, like Pauline, find that 5 mg does the trick. This reinforces our belief that everyone is different and may require tailored dosing to fit individual metabolism.
Anyone who would like to learn more about getting a decent night’s sleep, with or without sleeping pills, may find our guide Getting a Good Night’s Sleep of value. It can be downloaded for $2 at this link.
And please share your own story about dosing. Have you ever experienced what you thought was an overdose because you were a woman? Other women could benefit from your experience.