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.” D.M.G.


“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.” Rick


“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.” Gaby


“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.” Maria


“I’ve taken Ambien for five years. I only take 5 mg and sometimes split them in two. No problems. Just peaceful sleep.” Pauline


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.

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  1. Linda
    North Carolina
    Reply

    I hadn’t been aware before now of the 60 Minutes story, but my experience as a clinical psychologist supports this discovery. Over the past decade I have had 4 patients that I can recall right off the bat that had bizarre somnambulistic episodes on 10 mg. of Ambien (to include awakening to a police report she had signed alleging that an intruder had broken into her apartment, with no recall of this nor any real evidence of anyone breaking in).

    Interestingly, these patients were all female! Yet, I would estimate that at least 1/3 of my patients on Ambien have been male. Hardly a controlled study, but nonetheless interesting. (And for the person above who was suspicious of the binding agents in generics, three of these four cases were on branded Ambien–though I do agree that generics are often problematic. However, today more than 80% of American branded and generic pharmaceuticals are manufactured in either India or China.) In my experience, there is a subset of people of both genders who are supersensitive to medications and often do best on doses conventionally deemed sub-therapeutic..

  2. PC
    Reply

    I just saw the 60 Minutes piece on its second run. My Mother was put on Ambien generic when she was 90. Within her 1st 30 days she began hallucinating seeing train tracks and doors on my ceiling. One rainy night in August when I was in a deep sleep, sometime around midnight she went for a walk, in the rain, in her PJs and no shoes. Two young kids found her picking stones out of her feet and called the cops. She was almost a mile from my home. She had no clue where I lived, and thought she had asked me to join her.
    You could not pay me enough to take this. Mom was lucky and lived another 2 yrs with very few problems after she was removed from this drug.

  3. ror
    Reply

    As Lesley Stahl pointed out, this issue may apply to all prescription drugs, not just Ambien. And I’ve always wondered if the weight of a person is taken into consideration when recommending drug potency. To me, it just stands to reason a 105 pound woman would need less of a drug than a 220 pound man.

  4. Cindy M. B.
    Reply

    I’ve had exactly one instance of doing stuff in my sleep on Ambien. Yes it was scary — and fattening, since I seem to have eaten most of a jar of olives. But I average only 1 Ambien every 2 weeks or so, and for the most part it’s been a wonderful help to me.
    If I have anything stressful going on, or have something important to face in the morning, then I find I cannot get to sleep. Too many thoughts and worries that I can’t shut off! I don’t know what I’d do without Ambien for those times. The sleep-eating thing happened once and never again. And I’ve never had any kind of “hangover” or other problems, even if I take 10 mg.
    Even on 10 mg, I’ll sometimes wake up and start worrying again. At those times I might put another 2.5 or 5 mg, crushed, under my tongue to catch a quick 2 more hours of sleep… and still no hangover! So for me, Ambien’s been good. But my doctor, who reads all the negative stuff, now doesn’t want to write the Rx! It’s like pulling hen’s teeth to wrest a small Rx out of her. How I wish I coulda been there when some of you tossed your Ambien in the trash. Makes me cry a little. And by the way I do not trust Rx drugs and avoid them at all costs. Except for Ambien!
    PS: It’s true that there are great individual differences in response to drugs. I’ve seen a tiny little scrawny guy take twice the dose of something that a big burly guy takes for the same condition…. body chemistry varies so greatly! For each person, male or female, it’s vital to take a cautious, stepwise approach to determining that elusive “therapeutic window” in the case of a drug whose benefits truly outweigh the costs.

  5. Liz H
    Reply

    Sometimes the lowest dose is still too much. If you read research into your health issues, you may know why you should be taking less than the “minimum dose” With any luck your doctor will work with you on things like this. Unfortunately far too many won’t.

  6. Mariellen G.
    Reply

    I have been on various psych meds for 35 years. Eventually I learned the recommended dosages had been established with VA residential patients. That is to say, men who were bigger than me and probably much, much heavier than me, and more inactive as well.
    I could hardly put one foot in front of the other. I began working slowwwwly to reduce the meds, and as I was able to think and observe better, I noticed many of my friends in the self-help group, were just as bad off as I had been.
    Your recent editorial about psych meds being very bad for patients fits with my experiences. And, yes, women tended to be even more stoned than the men. I guess we can conclude that with the possible exception of birth control pills, all meds are tested on healthy young men.

  7. Merle K.
    Reply

    I’ve been taking Ambien since it’s been on the market. My normally good sleep became really disturbed after menopause, with problems falling asleep, staying asleep, and waking up early. I had tried the other drugs that had preceded it, like halcyon (also very effective, but no longer on the market).
    I went to a sleep clinic and tried all kinds of behavioral approaches for falling asleep, but remained anxious that I might not fall asleep. They gave taking Ambien their blessing to use for initiating sleep. It was a godsend bec. it always gave me peaceful and restful sleep, but only for 5 hours. So, I’d take 5 mg at bedtime and 5 mg. when I woke up in the middle of the night. I never increased to 10 mg., but when I began waking up in the middle of the night bec. I felt I had to eat something, something I’d never done before, I switched to Ambien CR 12.5 mg. That made me feel hungry @45 mins. after I took it, and before I fell asleep. I still had to take the second 5 mg. dose, bec. Ambien CR too was no more effective at producing a longer period of sleep, but was still preferable to no Ambien at all.
    Needless to say, given the expense of the brand name drug, I was thrilled when the generic came out. It was only on the generic that I experienced the unpleasant side effects mentioned in the article: daytime hangover and getting up in the middle of the night, barely conscious, to go and eat. When I found myself standing in the kitchen about to cook something, I was really scared. I immediately went back to the brand name drug.
    I recently decided to take only 5 mg at bedtime and 5 mg when I woke up in the middle of the night (by cutting a 10 mg. tab in half), to see if I could eliminate the CR pill entirely, since it really added nothing to the duration of my sleep, but doubled the already huge cost of the drug. So far so good with the new dosing regimen. No problems with “hunger” so far.
    I choose my Part D plan this year based on the fact that only 1 of 50 possible choices had Ambien on its formulary. I couldn’t get a straight answer from anyone, including Medicare, about whether or not plans would have to cover what was deemed medically necessary.
    This experience of having such a different reaction to the brand name drug vs. the generic, really made me question what fillers the generic was using which might make it different from the brand name, bec. this info. about dosage in women, only came out once the generic was in wide usage.

  8. SallyM
    Reply

    The 60 Minutes story was fascinating, and opens up a whole can of worms. I’ve taken Ambien only twice and I didn’t like the way it affected me, but perhaps a smaller dose might have been ok. I can’t remember, in the story, if the studies also took into account the height and weight of persons, male or female. I’ve always assumed that drugs were prescribed for my particular size (a small female), but, now I wonder.
    Both 60 Minutes and People’s Pharmacy have thrown a headline that seems intended to catch attention. “Does Sex Matter?” I expected a completely different story. The usage is correct, I understand, but it would have set up the story better, in my opinion, if they stuck to the term “gender.”
    My doctor of the last 15 years has studied women’s issues intensively, and prescribes and treats accordingly. She doesn’t take Medicare patients, unfortunately, as the FDA’s blanket recommendations often run contrary to what she’s learned. I feel fortunate that she’s solved a lot of my health problems, but also unfortunate because I don’t receive any health benefits and pay out of pocket, which to me is worth it. Sorry for going off topic a bit, but after seeing the 60 Minutes story, I’m thankful she’s been treating me and not a doctor who is beholden to the drug companies and handing out possible incorrect doses to women AND men.

  9. Roberta
    Reply

    I have used the generic for Ambien, 10 mg Zolpidem. No side effects… just restful sleep!!

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