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480448 tn?1426948538

Ambien: FDA Lowers Dose For Women

..FDA Says Ambien Dosage is to Be Lowered for Women
..By Vanessa Evans
.PostsWebsite .By Vanessa Evans | Yahoo! Contributor Network – 20 hrs ago....Email0Share0
Share0Print......The U.S. Food and Drug Administration issued a statement on Thursday revealing its decision to require that the makers of zolpidem, a common sleep aid drug, reduce the dosage that is given to patients, particularly women. The FDA issued the mandate due to the emergence of information that has shown that the drug can stay in a person's system for several hours after they wake up.


Zolpidem is commonly found in both generic and name-brand sleep aids. Ambien and Ambien CR are probably the most recognizable prescriptions that contain zolpidem, but it is also found in Zolpimist and Edluar, according to the FDA's statement.


Here is some of the key information to have emerged regarding the FDA's decision.


* The FDA is requiring that manufacturers cut the dosage in half for women and some men, citing the possibility that the drug's lingering effects may still make people drowsy or impaired in the morning when they are getting ready to drive to work.


* The Associated Press noted in a report of its own on Thursday that the FDA has different requirements for men and women because women absorb zolpidem more slowly, meaning that the effects of the drug can last longer at higher dosages.


* While the FDA is requiring that the prescribed dosage be cut in half for women, it is merely recommending that men be given the lower dosage.


* The Associated Press also noted that the change in the FDA's approach to zolpidem came after years of allegations and reports of car accidents in which the person involved had taken zolpidem the night before. The FDA could not link the drug specifically to the incidents up until now.


* CNN reported on Thursday that part of the FDA's investigation into zolpidem included running a "large driving simulation study" that found that some drivers who had taken the drug could not operate a car as well as other drivers who hadn't taken the drug or who were taking a lower dose.


* The New York Daily News, with the help of News Wire Services, delved into the actual percentages, and reported that in the study some 10 to 15 percent of women who had taken zolpidem the night before showed impaired driving ability eight hours later. Only 3 percent of men showed the same effects within the same time frame.


* In addition to requiring that the dosage be lowered for women, Dr. Ellis Unger, a director in the FDA's Office of Drug Evaluation, told the New York Daily News that everyone who has to drive a car first thing in the morning or do something else that requires "full alertness" ought to ask their doctor if using sleep aids is appropriate.

http://news.yahoo.com/fda-says-ambien-dosage-lowered-women-215300766.html

Ambien can be a scary drug...while of course everyone reacts differently, some people really have severe reactions to it, experiencing amnesia, a lack of impulse control, crazy stuff.

The thing is, that I bet the studies don't take into consideration the concurrent usage of Ambien, or other sleep aids, along with OTC meds that people assume are "safe", like Benadryl.  Benadryl is commonly used to induce sleep, or drowsiness, and it isn't rare to find people who use more than one sleep aid together, like Ambien and Benadryl.  That can produce diasastrous results.  Also, too many people are Rx'd a sleep aid for far too long, which actually worsens insomnia to the max.  Sleep aids are designed to be used for short intervals.

I would recommend, as a safeguard, that the FDA pushed for warnings placed on OTC sleep aids, such as Benadryl, Z-Quil, and the like, not to mix meds.  Benadryl is one of those meds where potential for abuse exists because people are so lackdasical about taking it...even giving it to their kids to quiet them down.
8 Responses
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377493 tn?1356502149
Ok, doing something and not being aware of it would absolutely terrify me.  One of the reasons I think I never really experimented with drugs is I hate the idea of not being in control.  It's also why I contain my alcohol to a glass or two of wine.  I once tried a hypnotist to help me quit smoking, and he could not hypnotize me.  I guess I was fighting him subconsciously.  It's a scary thought to me.  

For anxiety I currently only take something when I know a panic attack is coming and I can't talk myself down.  I was prescribed 25mg Quetiapine.  I can't even take a whole pill, so I cut them in half.  Talk about a hangover effect the next day...wow.  Fortunately I'm at the point I don't need them often because they just knock me off my feet.  The srip says to take 1-3, but no way could I take that much.  The half pill is just right, but still leaves me feeling dragged out.

I believe that drugs can be a really good thing for folks who need it, but do think that Dr.s need to take more care in discussing potential side effects and paying attention to other things (including otc) that someone might also take.  Warnings are very important.  For example, the med I mentioned above has no warnings at all on it.  I just happen to have a really great pharmacy that includes a print out with every prescription filled with all that info.  My pharmacist also does a really great job of discussing everything you might take, otc included.  
Helpful - 0
480448 tn?1426948538
LOL R!

Your wife is a smart one!  HA!

IO saw a show once where a guy painted the outside of his house one night on Ambien...ladder and all.  NO memory of doing so.

SCARY!
Helpful - 0
Avatar universal
I know a woman who takes Ambien.  While on Ambien she sometimes gets up in the night and binge eats, without any memory of doing so the next day.  Her son has sometimes awakened her during these binges.

Yikes!

I sometimes have insomnia, also related to anxiety.  I find Ativan helpful at these times.  I don't take it often because I know it can be addictive, but when the anxiety is really bad I take 1 mg at bedtime.  Maybe this would help you too.
Helpful - 0
206807 tn?1331936184
One morning I was getting dressed for work and could not find any of my work shirts. I looked everywhere. All of them were missing. My wife called me at work and said she found them; they were all in the washing machine. Apparently, in the middle of the night I gathered them all Clean and Dirty (some of them were on hangers in the closet) and washed them. Another time I posted on the MH HCV Forum in my sleep. My post made no since and almost all of the words were so misspelled; it was hard to make them out.
My wife said she was going slip me some Ambian and try to make me clean the house.
Helpful - 0
377493 tn?1356502149
Really?  You've had sleepwalking episodes on them?  That had to be rather frightening for you.  I am also a periodic insomniac and have tried a few over the counter sleep aids.  I dont find they really help much, and I am one of those who suffers from a hangover effect...I'm sluggish for almost the whole next day.  My Dr. has discussed Ambien with me, but I'm not so sure I want to go there.  In my case though, we know that my insomnia is directly related to my anxiety disorder, so for now we are focusing on that hoping that it helps to resolve the insomnia.  
Helpful - 0
206807 tn?1331936184
People need to understand, Sleep Aids rather OC or Prescribed are highly addictive. I suffer from Insomnia and if I take Ambian, Benadryl, Meletonin, etc. a few nights in a row, I won’t be able to go to sleep at all without taking something. Ambian doesn’t give me a hang over but only last about 4 hours. I've had a couple of sleepwalking episodes on Ambian. The only time I take them now is if I haven’t fell asleep by 1am.
Helpful - 0
480448 tn?1426948538
Definitely.

I'm always shocked to hear people who regularly give their kids things like Benadryl to maske them go to sleep.  Ugh, that's so wrong in SO many ways.
Helpful - 0
973741 tn?1342342773
Iteresting. We all know the disastrous affect of lack of sleep but people need to be careful.  In many different situations, the public is prescribed a medication and have no idea that by adding an easy to get, usually considered 'no big deal' over the counter product will actually potentially do them harm.  Things like benadryl and ibuprofen are taken without thought.  They can either compound side effects of the prescribed drug and some have issues all their own.  Warnings don't sound like a bad idea.  
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