The Food and Drug Administration is requiring makers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting patients face a higher risk of injury due to morning drowsiness.
The agency said Thursday that new research shows that the drugs remain in the bloodstream at levels high enough to interfere with morning driving, which increases the risk of car accidents.
Regulators are ordering drug manufacturers to cut the dose of the medications in half for women, who process the drug more slowly. Doses will be lowered from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations.
The FDA is recommending that manufacturers apply these lower doses to men as well, though it is not making them a requirement.
The new doses apply to all insomnia treatments containing the drug zolpidem, which is sold under brands including Ambien, Edluar and Zolpimist.
FDA officials say doctors should aim to prescribe the lowest dose possible that will successfully treat insomnia.
"Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate," said Dr. Ellis Unger, a director in FDA's Office of Drug Evaluation.
Unger said in a statement that the FDA has received a number of reports of car accidents connected to zolpiderm over the years. However, the agency did not have enough information to tell how much of a role the drug played in the incidents.
The agency decided to take action after recent driving simulation studies showed that, in some patients, drug levels remained high enough to cause difficulty driving.
For now, patients should continue taking their currently prescribed dose until they can talk to their doctor about the best way to proceed.


I think people are taking it at midnight and trying to get up at 5 am for work. My wife and I both take it and after 7 or 8 hours neither of us have any problem whatsoever.
Yes, same here. Another example of the government trying to fix stupid.
I remember the flight doc telling me quite clearly you need to have 8 uninterrupted hours to devote to sleep. If you get up during that time, you won't even remember it, never mind function properly.
The funny thing is, trial after trial have found that the average Lunestra and Ambien users only get an additional 20 minutes of sleep per night. A similar sleep study was conducted with fish oil pills - the result? An additional 35 minutes of sleep.
Fish oil can't be patented, however, so the billion dollar industry has been shoving these designer sleep drug ads down everyone's throat for the past 5 years with insane success.
Store brand sleep meds work for me fine. A normal dose is 2 pills but it makes me groggy in the morning, so I take one. Did the Government really need to get involved with this?
Mark, Count me in as well. I have been taking it for years, but always make sure I have time to get a minimum of 7-8 hours sleep, otherwise I won't take it.
Sorry Dman, I don't know anything about the study, but I take 2 fish oil caps every night and it doesn't seem to affect me at all as far as a good nights sleep.
Ambien has been used in nursing homes for quite some time to 'sedate' the elderly ... so the workers don't have to deal with them. Maybe now they will actually interact with their patients instead of medicating them. Nah, probably not.
There are plenty of natural remedies for helping people sleep. Knocking someone out doesn't promote healthy sleep with good REM state ... it just, well, renders them unconscious for a few hours. Dream Water works well without morning drowsiness, but Big Pharma can't make their billions on that, can they?
I agree - this is more about people taking the pill only after they have tossed and turned trying to get to sleep for an hour or two and not giving themselves the recommended 7-8 hours before they have to get up. If people gave themselves the recommended number of hours before they had to get up, they would not have trouble driving in the morning. Part of this is also that the typical American working age adult does not get 7-8 hours of sleep during the week, most only get around 6 hours. This is why they are still drowsy in the morning after taking these drugs, not because of an excessive dose of sleep meds.
Hmmmmmm I'm wondering why the FDA didn't recommend that users cut their pills in half, which accomplishes exactly the same thing as a stupid new regulation, PLUS, the pharmaceutical companies would only make half of their profits...........................................................Oh,...... I get it now, never mind!
Back off FDA. I have taken Ambien for years due to insomnia from menopause. No problems whatsoever. I play by the rules. My doctor and I need no micro-management from a government agency. The main reason people cannot sleep is the anxiety induced society we live in today. Worry about everything because everything is so screwed up and unpredictable. Nothing over the counter works for me. Never did. BTW - Ambien does not work for everyone. Wow!
What's the difference. Take it, sleep well and be unsafe driving to work,
Or take half the dose, sleep like crap, and drive unsafe to work.
1st world problems.
Ahhh if you only knew...
D.Man, I suppose that is why the FDA is concerned about it or people are having a hard time functioning if they don't have 8 hours of uninterrupted sleep!
Don't worry, someday they'll invent a drug for stupid!
the 10 mg dose of Ambien definitely makes me mildly groggy in the AM, but maybe that's because I'm a smaller-sized person. The 5 mg dose works much better.
the extended release made me way too groggy so I stopped that after 1 or 2 tries.
Some pills cannot be cut as they are in those stupid plasticky (no clue what the covering is) format. I have not taken ambien or the generic of it, so I do not know if this is the case, just wanted to raise the point that it may not be possible for them to cut the pill.
I have been taking the highest mg of Ambien for a couple of years and have no trouble whatsoever. If I don't get enough hours of sleep, sometimes I feel groggy getting up, but once I shower and get ready, I feel just fine. I tried everything before this and nothing worked well. Fish oil, DMan?! Please! You have obviously not had real insomnia.
I took this stuff for a couple of weeks and finally dumped the prescription in the toilet. Felt like I was floating through the day, couldn't think, had mild amnesia and even a bit of depression. Exercise and a complete change in diet did the trick for me.
Perhaps this should have been looked at as a option for women who are still working but for women accross the board it is unfair. The next thing is that the food and drug administration are overstepping their bounds. Soon the doctor will be perscribing your menu and they will ship you your meals pre made and packaged and that is what you will eat. Like it or not. The government will not allow anything else. And if you are caught with food other than your own the insurance that is mandatory that you pay for will not have to cover your illness.
It is called social reform and your president is all for it.
@ David
If you're going to call someone stupid, at least make sure. You do it. With a grammatically correct. Sentence.
Wow! Another example of a few people that will not take medication as prescibed and screws everyone else their right to be treated properly! Now, again, hears comes the government controlling even our medications prescribed by our private physicians. Which by the way my husband served 20 years in the Air Force for the benefits after retiring then worked 20 more years for the government to have a small retirement. And it still is outrageous due to cost to be seen by doctors and specialist and hospital stays and then medicaction. Come on people please just take the medicine correctly. Get real if you don't sleep 8 hours a day then talk to your doctor!
Craxy Mary,I agree with you on this.I took it once to get my sleep pattern back on track.I slept for 8 hours and had no problem the next day. I've never had to take it again.I think that people lie to their doctors to get this prescription.It seems that more people take it nowadays when they can change their eating,drinking and sleeping habits to cure their problem of not being able to fall asleep.At half the dose a person may as well take one of the over the counter PM med's.
I just smoke a little pot....my tummy hates pills
loulow,That always worked for me when I was in a horribly stressful job.Haven't needed it in 15 years.But I think that it is more natural and safer than all of these pills the doctors are pushing.
Agreed - I don't take one much past 10:00 PM if I have to get up at 7:00 AM else I'll be groggy for most of the morning. If I miss my deadline, I just don't take one and deal with it.
And limiting the dosage is about as stupid as limiting the size of soft drinks. If one limits the dose, nothing is preventing the patient from simply taking two to meet their pre-limit dosage. Stupid, stupid, stupid.
Mike,I agree with your post.
This is obviously somebody meddling with nothing. After 3 hours,Ambien is worthless. The first hour, I do stuff I can't remember the next day like eating something. But never anything bad. I'm perfectly normal, because people have told me, but I don't remember it.
I don't know about ambien but the FDA and the government is a joke.
Really?? EVERY drug you take was evaluated by the FDA. If it didn't exist you'd probably be taking lots of snake oil.
Well, the government invented the Internet you're using, so you'd best log off it forever. Buh-bye.
My bro almost died w/ the Ambein that the hosp. was pumping in him; his kidney was closing down; he was turning blue; it was awful!!! Yes they do feed them to elderly or the disabled so they stop pressing the nurses button etc...but my Bro has a lung disease & the ambein
Profran,You and or your brother should have reported that hospital.
Will they cut the price of the prescription in half? I don't think so. FDA providing even more profit to the pharmaceutical industry, what a surprise.
John: It's dangerous to cut long-acting drugs in half. It releases the drug faster than intended in your system.
It appears that our government believes people are no longer able to think for themselves OR follow doctor's orders, which clearly state you need at least 8 hours to devote to sleep if you're taking a prescription sleep drug. Limiting the dosage is a stupid idea. People will just double up. Over the counter sleep aids work ok and you don't hear about "sleep eating" or "sleep driving".
I love how these sleeping pill commercials show a person waking in the morning with the sun shining in and them streching and smiling feeling great. The reality is you are groggy and feel like an elephant is sitting on you while trying to get up. Yes you crash, but the sweet smiling wake up is not true. Even though I take them early enough, I feel the effects for a long time during the next day.
I had to ground test four different sleeping pills while I was in the military. Can't remember all of them, but the one that worked for me was ambien. It helped me sleep without feeling bad the next day. Probably depends on the person as to what works for them.
Yeah I have never taken Ambien. When I have my days of not able to sleep right, I take whatever is available over the counter. I guess they make a difference
Try melatonin. It's the hormone secreted by the brain during the day that puts you to sleep when it gets dark. Doesn't always work, but I never had any side effects the few times I used it.
Melatonin always makes me feel like I have a hangover the next am.
I have vivid and very odd dreams on melatonin as well!
Funny, and tell me if I'm alone, but if I eat cheesecake right before bed, I have vivid and horrible dreams. It must somehow kick in some chemical like melatonin.
Disclaimer: I do not take prescription sleep aids for any reason ...including recreation. I do take the OTC Melatonin. If you are wondering why I know about a medication I don't take, I've worked in a pharmacy and resident medications are part of my job as a overnight counselor.
This is a stupid move on the FDA's part. 1] People will just double up on their old dose. 2] There is already a 5mg and 6.25mg CR Ambien available, so if the physician felt it was the proper dose for their patient, they'd prescribe that. Also, there is nothing to stop doctors from prescribing two tablets, so basically this action by the FDA does nothing.
The FDA just wants to appear to be looking out for us... they're not. Their real mission is to protect the profits of their benefactors in the drug industry.
The problem is most doctors use the 10mg dose by default. I was on the 10mg dose of Ambien for about three years, and was having problems with lag in the morning (and not really realizing it) even though I was taking it eight hours or so before I had to be up the next morning. Eventually I fell asleep at the wheel on my way in to work, and I had to insist, and I mean really insist, that I get the 5mg dose. Now I have been on the 5mg dose for about 18 months, and it works just as well with little to no lag. When I dont take it, I have less problems with "dependency" and am able to fall asleep naturally better than I used to be when I was on the 10mg dose.
My father, who has been on the 10mg dose for eight or nine years, has taken one of my 5mg pills a handful of times when he forgot to pick up his prescription, and it works for him just as well, so he started just splitting his 10mg tablets to save on cost.
So as someone who has taken Ambien for years, I think this is a good move. If the 5mg doesnt work, a patient could always take more.
or you could exercise and sleep like a baby.
No mention of those other side effects:
* headache
* dizziness
* drowsiness
* diarrhea
* constipation
* difficulty walking without an unsteady gait
* flatulence
* shaking of the arms or legs
* appetite changes
* unusual dreams
* dry mouth
* dry throat
* heartburn
* tingling in the hands, feet, legs or arms
* pain or burning in the hands, feet, legs or arms
* tingling of the tongue
* burning or redness of the tongue
* ringing in the ears
* tingling in the ears
* itching in the ears
* redness of the eyes
* muscle aches
* joint pain
* back pain
* neck pain
* difficulty breathing
* difficulty swallowing
* rash
* hives
* swelling of the eyes, lips, tongue, throat or face
* rash
* itching hives
* itching
* throat closing up
* hoarseness
* shortness of breath
* pounding or racing heartbeat
* vomiting
* nausea
* chest pain
* blurred vision
* vision problems
Symptoms of overdose:
* excessive drowsiness
* slowed breathing
* slowed heartbeat
* coma
Ambien can cause impaired thinking. After taking Ambien during the night, do not operate a motor vehicle for at least four hours after waking up in the morning. Ambien can leave the user feeling drowsy the next morning. Never take Ambien with alcohol or after consuming alcohol during the day.
The U.S. Food and Drug Administration classifies Ambien as a category C drug. The ambien side effects of the drug on pregnancy or to the unborn child is unknown.
The Side effects of Ambien are terrible. I was prescribed it and quit taking it because the side effects were so bad. The above list is real people. Find something else to take to help you sleep. It should be taken off the market...
Never had any of those problems with 5 mg. Ambien I take very occasionally. Works beautifully for me and gives me a good night's sleep.
sleep drugs don't work:
http://articles.mercola.com/sites/articles/archive/2007/11/15/sleep-drugs-are-wildly-popular-despite-barely-working.aspx
improve sleep naturally:
http://articles.mercola.com/sites/articles/archive/2011/02/04/17-ways-to-improve-your-sleep-hygiene-tonight.aspx
http://articles.mercola.com/sites/articles/archive/2009/01/06/8-natural-remedies-that-may-help-you-sleep.aspx
I hate to sound like a self-righteous old woman, but Ambien only treats a symptom. Why not examine your life to discover why you can't sleep then address that? Maybe stress management, a better diet, exercise, or something else.
Of course there are exceptions, like pain or managing the stress of a serious disease, hormonal imbalances due to menopause or surgery or disease, etc, but I have a completely unscientific hunch that most Ambien users aren't grappling with anything like that.
Martha, you are right that a good exercise regimen works wonders for many conditions, including a good sleep. I think what we have today is a stressed out society, lots of desk jobs where the person is busy mentally, but not physically, and easy answers in available drugs. But that easy answer just makes things more difficult in the long run.
Martha,You hit the nail on the head with the Menopause insomnia.ambien took care of that on a two week course.Never took it again because I didn't need it.
I've never taken Ambien, but I have taken some over the counter stuff which works well enough. But is it just me that becomes extremely hungry once the effect kicks in? Yes munchies.
When I do as required, for the best possible result, devote at least 8 hrs to sleep, I wake up wide awake and rearing to go, not groggy. Now when I take a Tylenol PM to accomplish the same thing, I wake up groggy and stay that way for a few hours.
I'd be more worried about people using toomuch PM's that are over the counter............they are far worse and easily misused or abused.
Then maybe its the ones I have been taking, since I just get whatever the local pharmacy has. The act of putting me to sleep works well enough, but yeah I feel it almost the entire next day. Same when I take a Benadryl.
TFNJ... got news for you. Just about all over the counter sleep meds are benadryl. Check the label... diphenhydramine - better known by it's brand name of benadryl. Same for over the counter pain meds that have promote sleep (Tylenol PM). They have just added benadryl. Save yourself some money. Buy the store brand "benadryl" instead of the brand name sleep med.
I already do, due to allergies. But yes noticed that a side affect is also the drowsiness. So I did some reading on the origins of diphenhydramine. Its interesting that at first, it was created as an anti depressant. It has the same effect as the earlier versions of Prozac. releases the... someone remind me of the chemical.. Seratonin? Whatever is released in the brain to calm you down.
Interesting long term side effects.
Once again, at the risk of sounding like a self-righteous old lady, what's the point of taking a sleep aid if it makes you groggy the next day? How is that better than a restless night of sleep? Then, if you are groggy, you probably drink lots of caffeine to compensate and the cycle deepens.
Martha, the difference is that people who don't sleep start to lose their mental ability. I myself get strange after a few days of no sleep. By that I don't mean I take these pills often. But there are times when there is some stress in me, and I'm a naturally hyper person who can't shut his mind down. To the point of anxiety. So after a few days, and I start to say weird things, I take a pill. I might be groggy the next day, but at least I slept. The grogginess isn't overwhelming though. Just a light fog.
TFNJ - thank you for sharing. I've had similar mind-racing nights, but never long-term. I can understand how prolonged sleep deprivation could be extremely debilitating.
peechyrose,You are absolutely correct about the Benadryl,the oldest allergy medicine on the market and the most effective one for allergies.It's the cheapest too.
To the above reader who recommended fish oil, I take Lovaza (fish oil) and it doesn't do anything for sleep inducement, though it's good for other reasons. I was given a prescription for Ambien because I can't sleep past 2:00 am. The first time I took it, I slept like a rock for probably 9-10 hours, but awoke in the morning with way too much residual left in my system. I felt like I was drunk driving on my way to work. It was obvious to me that I should cut back the dosage. I now cut the pills in half and take before bedtime at a reasonable hour (9:00 or so), get recommended 8-10 hours of sleep, and get up in the morning with no leftovers that affect my behavior. For me, cutting the dosage down by half is a good idea. I'm a woman of fairly large stature (5'9"). One full tablet was way too much for me. For women of small stature, I can imagine one pill would be way overkill. But either way--one pill or a half a dose, I still wake up somewhere between 1:30 and 4:30, just like I did before I started using Ambien, and I have never had a problem with not knowing I was awake or with sleepwalking. I also don't use it every night. Just when I get into a pattern where I can't sleep through the early morning hours. Melatonin also helps, though some people report bad dreams. I had dreams, but they weren't bad.
synthetic pharmaceuticals are designed for shareholders,
thank god for natural herbs and marijuana,,,,
Yeah, all those cancer patients should just take vitamins and herb tea and smile. They'll be dead a lot sooner, but at least they'll have good levels of Vitamin C!
Pharmaceuticals definitely help when used judiciously and for the purpose for which they are indicated, but there is no denying that overuse and misuse are rampant in our culture.
Martha,You are correct again.Great comments from an intelligent poster.Thank you.
Yeah! Good morning everybody! :)
Just smoke some weed. It'll put you right to sleep and you'll feel great in the morning with no real side effects. Of course big pharma doesn't want you to know that,
Buying weed has some frequently bad side effects: getting arrested. It's also incredibly expensive (at least where I live). I get the generic Ambien for $10 a month.
Ambien doesn't make me binge eat or paranoid, either, ala pot.
Not a big fan of Ambien (had it a few times while hospitalized after surgery since I can NOT sleep in a hospital comfortably).
Melatonin is best for me, and best when taken with some Valerian. Valerian smells something awful, like a combo between Parmesan cheese and Athlete's foot left untreated for 3 months- but is very inexpensive and can easily be obtained where herbal supplements are sold. Take this advice from an ex-Benadryl junkie. Give yourself at least 6 hours (being realistic) and expect an hour "hangover". 7+ hours you should be great.
There is another product that has both plus Trytophan (the stuff in turkey that makes you drowsy)- but I have not tried it, mainly because the cost is outrageous.
Start with the lowest dose of Melatonin, since they have 1,3 and 5 mg pills. 3 is best for me, sometimes a little much. Just one is barely enough. I break the 5mg in half, and golden.
Sweet dreams...
I gotta agree with ya there Sammy, but my natural herb costs me waaaay more than my Ambien, and unfortunately the pharmaceutical companies aren't covering it here in Fla? I wonder if they cover it in CO or WA? Anybody know?
You just can't fix Stupid. The people that are having trouble are the ones that take the drug at midnight then try to get up at 5 and be on the road by 6. If you do this you will still be asleep while driving. If you are using 10 mg and then are cut to 5 mg it isn't going to work. I was on Ambien for 10 years and i have tried all combination but the only thing that worked was the higher dosgae. You have to take it at least 8 hours before you are going tobe awake otherwise you might be up but not awake.
There is a great sleeping pill (4 hr) that the Dr has prescribed for me. I have no problem getting to sleep, but wake up a couple hours later. I can take Sonata at 1 AM and get up at 6 with no drowsiness at all.
FDA approves the sale of cigarettes to white trash - smoking must be healthy!
cigarettes aren't classified as drugs. FDA doesn't regulate them
You can tell by Bob's avatar he is strictly Haute cuisine day in and out, and has no room for 'smokers'.
Pole smokers are the exception.
Sleep deprived drivers kill more people in auto accidents than people who didnt allow themselves enough time to sleep after taking Ambien. I take Ambien and wake up 6.5 hours later feeling wonderful. The results from taking Advil PM and Melatonin are the complete opposite. I can only hope they dont make this a requirement for men as 10mg barely works for me and thats only when taking it on a completely empty stomach.
Let's just hope you never drive while under the effect of Ambien, like one of my friends did yet had no recollection of the next day. With Ambien you AREN'T sleeping, your brain is disonnected in certain ways that make you think you slept.
UDunnoBro: I think you are talking out your posterior. Your personal experience does not equal everyone else's. On the few nights a month I use Ambien (after a few lousy nights of sleep), I wake up feeling fantastic and well rested.
I agree with TraceyS. I take Ambien, never had a problem with sleepwalking or driving or eating that I can't remember, or any other such thing. I sleep well, and whatever you're talking about, UDunnoBro, I've never experienced that "disconnection" you refer to. But I only take a half a tablet. One was too much for me, and I'm not a small person. So if a small person takes a full dose, and can't remember doing things, then maybe they DO need to cut their dosage down. The thing people need to remember with drugs, any of them, is that one size does not fit all. I sleep well with Ambien, and have no problems. But I only take a half a tablet. That's what works for me. Somebody else might need something different.
People also have to remember that many of these pills are habit forming. You take one, sleep great, so take one soon after. As time goes by you find yourself dependent on a pill to fall asleep.
Take with care
VERY TRUE!! (although the drug companies claim they are not habit-forming...yet they most definitely are)
Because they are playing with the meaning. Sure they may not be physically addicting, like some street drug. But psychologically they are, due to dependency.
Bart, Ambien is a schedule V drug, nobody is claiming that it isn't habit forming. Except for you that is :)
honestly the crap should be banned. lived with a person that was on this crap and actually moved out for fear of my life. person would regularly be up and moving at night, sometimes aggressive, with no recollection the next day. after the 2nd fight with my room mate, who never remembered the next day, I moved out.
Sax: Your personal anecdotal evidence does not mean that most other users have not found benefits in it. Let's "ban" it because it didn't work for your roommate?
my personal experience is far from the exception
It works beautifully for me and many others. Don't have a good experience with it? Don't take it.
Sax,
Maybe your roommate had another psychological issue and insomnia was one of the symptoms.
Now if that was happening to even 10 percent of the people who took Ambien nobody would want to prescribe it.
I have a friend who used this stuff and one morning he found his truck parked in a different spot from where he left it. At first he thought someone had jacked the truck, or maybe he was pranked. But the truck was locked, the mileage hadn't changed from the previous evening when he parked it (he's religious about tracking this for his gas usage), everything in the truck was in place, and the steering column locks so there's no way it could have been maneuvered around two corners to get it into the new spot without driving it.
Conclusion: he moved the truck while he was "asleep" on Ambien. I'd steer clear of the stuff.
One other thing about Ambien, my girlfriend used to take it and sometimes she would get up around 4:00 AM and take another one while she was under the influence - not due to dependency so much as a zombie action due to the effect of the drug. So she would end up zoned out in the day, sometimes for days.
i woke up one night to my former roommate organizing about $200 worth of lunch meat on the counter in the kitchen. he had drove to the store, bought all the lunch meat, and then drove home without any memory of ever doing so. Ambien scares the crap out of me.
also had a good friend I grew up with get stabbed and killed by her husband, who then stabbed and killed himself. he was on ambien, and I bet he really wasn't aware when he killed them both.
Ambien is only supposed to be taken for 10 days or less for one... it is mentally addictive...you have to ween yourself off of it or you can have some very ugly side effects. It can damage your brain... it should be taken off the market... research it...