FDA wants Ambien doses cut for women because users are crashing cars the morning after

The Food and Drug Administration today announced it will require the makers of popular sleeping pills like Ambien and Zolpimist to reduce the recommended dosage in half for women, "after laboratory studies showed that the medicines can leave patients drowsy in the morning and at risk for car accidents." Women eliminate the drugs from their bodies more slowly than men. (NYT)


  1. Wait, what? Do people just keep taking the recommended dosages even after trying it once and finding you’re still high in the morning? Perhaps they’re driving while on Ambien on their very first try… but still…

    I’m small, unless its antibiotics, I start with 1/2 and take more later if I need it, especially if it’s a one-size-fits-all drug, no way I need the same does a man twice my size needs! 

    (There was an incident that ended with me buying 15 calendars while on a whole dose of Klonipin when half would have been just fine.)

    1. Well the last time I checked Ambien isn’t an OTC drug.  So I do place some level of trust that my doctor (or the one prescribing it) has some idea about my weight and how that will play into the drugs affect on me.

      1. You trust doctors too much. Many of them just write out the same script for everyone. They shouldn’t, and the really good ones don’t. Unfortunately, a lot of doctors aren’t “really good”.

      2. Everybody’s metabolism is different, and reactions to drugs are affected by more than just body weight.  Especially for drugs affecting mental state, dosage guidelines are just guidelines until you see how an individual reacts to them.  (That’s even more true for drugs that you’re taking because your metabolism or brain chemistry aren’t working normally.)

        My doctor’s dosage recommendations on sleeping drugs has been “Let’s start with this drug at this dose, see how you do, if it’s not enough we’ll try a large dose or switch to a related drug.”  First one we tried helped me sleep well, but left me groggy all day, which was just not the point, so we switched to something with a shorter half-life.

        And with Ambien, there are lots of reports of people reacting really weirdly to it, so you’d expect doctors to need to experiment with dosage.

  2. The FDA sounds very sexist. Can you imagine them doing this to men, instead? “We’re going to take care of you, dear.” “Gee thanks.” Methinks the dosage is between the doctor and patient and whatever that individual’s medical needs are. Of course, this would also increase the cost of prescriptions for women. As usual, in healthcare, women get taken to the cleaners in a greater degree. The FDA is so fullofvit.

    1. There are measurable differences in reactions.  If you’d read the short post above, you would have learned that the drug spends longer in the system of a woman than a man.  That’s a common difference in reaction between the sexes, in fact.  It’s not always just a physical size issue.

      How do you think a doctor knows what prescription to give a patient, and at what dosage?  They don’t make it up on the spot: they get guidelines from the drug companies and the FDA.

      Finally, taking half as much means each dose will cost women less, not more.

      Edited to add: I see that the post I responded to has been significantly changed, without admitting to it. Bad form.

      1. Don’t believe every short sentence you read.  Besides, I hope a doctor knows what prescription to give patients because they know the PATIENT and because they went to medical school and because they can think independently of the FDA.  You don’t make a blanket decision on prescriptions for millions upon millions of people because of physical size.  There are many factors that go into prescription decisions.  There are small men, for goodness sakes.  Men who are smaller than women.  Question authority, particularly when it is based in patriarchal tradition and corporate funding.

        1. Women metabolize drugs differently than men, our body fat ratio makes drug metabolization very different than for men, so it’s not just weight, and it’s not sexist. A 140lb woman will need a different dosage of a lot of drugs than a 140lb man. Compounding pharmacists are your friend.

          Women get screwed over in a lot of areas (don’t get me started about dry clearers!) but I don’t think there is a patriarchal conspiracy to overcharge women for medications. 

          1. Beyond your “conspiracy” hyperbole, my body is not your body.  And I don’t think hers is yours either. If you’re under the influence, don’t drive. You’re an adult, I take it.

            BLUE ELM:

            YOU WRITE BELOW: “I think you misunderstand the situation. If you take the dosage as prescribed to sleep you may not *know* you are still drugged in the morning. Having taken the drug one thing I can attest to is that it isn’t great. However, basically you are saying if you have a sleep disorder don’t take sleeping pills and don’t work and don’t do anything. In other words, you’re kind of hugely missing the point. Perhaps you’re under the influence though.

            I mean I get it. Don’t have a sleeping disorder! Duh! Why aren’t more people as brilliant as you!?”

            The board is not letting me respond to your insults; isn’t that interesting when you post here so often?

            Who funds boingboing? You all love the crooked FDA so much.

            I misunderstood nothing and that is NOT what I am saying. If 5 mg doesn’t help a person sleep, then why should they take the narcotic AT ALL?

            I hope that helps you wrap your simple mind around the concepts. After all, you and your friends are so obviously intent on learning via rational discussion.

          2. I think you misunderstand the situation. If you take the dosage as prescribed to sleep you may not *know* you are still drugged in the morning. Having taken the drug one thing I can attest to is that it isn’t great. However, basically you are saying if you have a sleep disorder don’t take sleeping pills and don’t work and don’t do anything. In other words, you’re kind of hugely missing the point. Perhaps you’re under the influence though.

            I mean I get it. Don’t have a sleeping disorder! Duh! Why aren’t more people as brilliant as you!?

        2. As has been said repeatedly in this thread and you seem to be having trouble parsing, it’s not about physical size. I’m 5’9″ and 250 lbs, only Andre the Giant would call me petite and even then only ironically. I’m taller than my husband, too.

          It’s not sexist to say that progesterone pills will act as a birth control agent for me, but not for him. It’s not sexist to say that surgical sterilization is an outpatient procedure for him, but not me. Sexism is about prejudice – about inaccurate information.

          This is accurate and I want my doctor to have access to accurate recommendations on the dosage per kg of drugs when they need to be varied by sex, by ethnicity, or by what side of the damn street I live on.

          1. Some of us have been reading before posting and we see that others are responding to posts about size, and that those original posts have been changed since their argument was defeated. I think some people know that too .. ;)

        3. You’ve just proved to me that most of the men on this site (to say nothing of the women) are better feminists than you.  Thanks for that cheery reminder.

    2.  Yeah, I fully agree. I have a very fast metabolism and 5mg of Ambien wouldn’t keep me asleep for longer than about 2 hours. I know. I’ve tried it. I never get a hangover from Ambien or melatonin or Benadryl or Nyquil or actually, any medicine I’ve taken and most wear off long before they are supposed to.

      1. Well Ambien actually fails at putting me to sleep in the first place, but it’s GREAT for hallucinations!

          1. I seriously found myself trying to rescue a chicken that wasn’t there from a snake that wasn’t there. I also found myself microwaving pizza in the middle of the night after taking it. Good times. Give me good old valium any day over that stuff.

        1. Halcion did that for me. No sleep, just that same fun feeling that you get when you have a high fever.

  3. I took the recommended dose of Ambien once or twice, and realized that it was a 12-hour drug for me.  I don’t use it often, but when I do I take half a dose and that works perfectly.  I wake up alert and refreshed.

  4. There’s a whole big issue about the fact that drugs are mostly tested on men.  Because the womens have the hormones and whatnot.  As a result, ‘safe’ or at least ‘predictable’ drug actions generally means ‘safe for men’.

    1.  I stand to be corrected, but I think one of the reasons men tend to be test subjects more than women is because there is a fear of birth defects arising from drug use.

      1. Probably part of the whole thought cluster.  But of course, all that would mean is that the drug would be given to women without knowing its teratogenicity (in humans).  That would be a solution that’s worse than the problem.  If it’s safe enough to prescribe, it’s safe enough to be properly tested.

          1. The best solution that I can see is to admit that teratogenicity safety is based on rat testing and do human testing on women of various ages with the understanding that women of fertile age know the risks. We already prescribe teratogens with big black letters on the box that say don’t get pregnant.

          2. Sort of off topic, but my favourite baby sitter growing up had been a thalidomide baby. She didn’t have arms, just fingers coming out of her shoulders, she could hold a tea cup in the fingers, but she ate, and did everything with her feet. Best baby sitter ever, always fully booked, because we loved to watch her eat with her feet.

      2. They test male rats not female rats, because of the hormones. There’s hopefully a small female rat trial to make sure it doesn’t have tetrogenetic effects but it’s an afterthought. Then you move on to a human trial and again, tends to be on young men – because that’s a standardized sample. Often young white men who go to university, because they’re handily concentrated in one location, need beer money, and sign up for stuff.

  5. As a female with peri-menopausal insomnia, I found out really quick that I only need 1/2 a tablet and I only take it when the cyclical wave of insomnia strikes.  So one prescription lasts me a long time.  Who in the world can’t figure out that 1/2 a tablet works as well (or better) than a whole one?  So they’ll cut the dose, probably keep the cost the same so now it’ll cost more for the same effective dosage.

  6. There are people who get into traffic accidents because they don’t sleep.  In fact, driving without a night’s sleep is considered equivalent to drinking and driving. If anything, these drugs should be more easily available.

    If someone is “driving under the influence” of a narcotic, that’s a job for law enforcement, not the FDA.

    1.  If someone’s being overmedicated, that’s a health problem. Overmedication can cause health problems – any side effects are going to be more pronounced and more likely, and with sleep aids you start worrying about central nervous system depression and death if the dosage is too high.

      1. The blog entry says it’s because they’re “drowsy in the morning and at risk for car accidents.”  That’s not the job of the FDA.  It’s the job of the police.  Plenty of drugs don’t combine well with driving. 

  7. From the prescribing information sheet:


    Adult dose: 12.5 mg once daily immediately before bedtime
    Elderly/debilitated/hepatically impaired patients: 6.25 mg once daily immediately before bedtime
    Tablets to be swallowed whole, not to be crushed, divided or chewed. Should not be taken with or immediately after a meal 

    So an MD would look at this and write 12.5mg qhs prn (which means every night before bed if needed).  There is a mention to cut the dose in half for some folk, but not for women.  note there are only two strengths available according to this form – so you can’t rx 8mg or something odd, bc it you can’t divide the dose (they’re probably coated, so cutting the pills gives an improper rate of absorption or some such).

    Many drugs are prescribed in mg/kg, which helps adjust for body size. That takes no account of different breakdown rates according to sex.

    Please don’t blame the physicians for the dosages – the rx info gives them NO information to the contrary.  With only that info (which is all they have), any two 150lb people would.should get the same dose.  A smaller human may get a smaller dose by normal logic, but two people of the same size will not get different doses based on sex bc there is nothing to lend that data point (until now).

    So the change is good and needed since the information is now out there.

    The conspiracy theorists may now discuss how long the PharmaCO knew this data without releasing it to the FDA…

    Denver, CO
    The FiatRN

    1. Can a re-compounding pharmacist coat pills for time release? My mother has to get one of her rxs at the only pharmacist in a city of 1.2 million people who will re-compound pills since her dosage is 1/3 that of the smallest size available. He takes the higher dosage pills, grinds them up, blends with more filler to make the smaller dose pills big enough to handle, and uses manual pill pressers to make her new pills. It’s pretty cool, and he calls his store the Apothecary which is just sweet

  8. I think this looks very strange. I’m an average size woman and I cannot sleep without 10 mg.  5 mg doesn’t work at all; it’s useless; they might as well be telling me I can’t have the medication no matter what my doctor says.  People have different medical issues and metabolisms; it’s not all about size, and there are men who are smaller than women.  Can you imagine them depriving men, as a group, vs women?  “For their own good?”  With one of the most popular (for good reason) and common medications (for good reason) in the U.S.? Or having studies to find a reason to? No, of course they never would. When I use 10 mg, it’s a perfect dose for me.  I go to sleep, and I wake up refreshed and well rested, not groggy and half-conscious.  But if I don’t sleep, I’m disfunctional.  Clearly this is about power, and abuse of power, not medical issues.  And if it’s about driving, it’s up to the police, not the FDA.  It’s about being a law-abiding citizen.  Don’t get behind a wheel if you know you’re under the influence of a narcotic.  Do you need the FDA to take away your beer too?

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