Messing with the meds again - Ambien under new rules from FDA

A lot of us on this board are prescribed Ambien, or it's generics. According to a ruling today, The FDA is requiring lower dosages. Women will have the dosages cut in half, since they seem to take longer to get it out of their systems. There are recommendations for the same for males, but no requirements.

(copied from an AP report) - 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. (end copy)

They are not saying to change your dosage now, but be prepared when you go to your next appointment to have a discussion about it.

My psychiatrist prescribes mine, and something tells me he's not gonna budge. But I'm a big guy, I don't know what he will do about the females he sees.

Yeah, the ABC and AP reports seem to differ in that respect. I certainly don't take mine and go out for an evening drive... I don't even go outside.

I was taking my info directly from the AP report, as posted on the Washington Post website, which seems to be directly quoted, as the exact same story appears in many other places on the web, attributed to AP

One of the things that I also picked up from the reports is that any new sleep drug that comes up for review has to basically pass a driving test. In other words, how well subjects do in driving simulators after taking it and sleeping. This is a new wrinkle. Not necessarily a bad thing for public safety on the roads, but it does take the teeth out of some of these meds, as it's likely only going to include otherwise healthy non-smokers, as most clinical trials do (I tried to sign up for some in Austin when I was younger for the extra cash, but I was a smoker. All I could do was sell my plasma twice a week)

Here is what I read & understood.There is a drug called Zolpidem in Ambien and several others sleep meds. A study was done on the extended release version of Ambien and it showed that 33% women still had a high amount of this Zolpidem in their systems after 8 hours of sleep and 25% of the men had it too. When they did the driving simulation part of the study it showed persistent drowsiness after 8 hours. Women metabolize this Zolpidem much slower than men for some reason they say. So based on this info this is why the FDA is asking the mfg's to lower the dosages and they are asking for a reduction of cutting the doses in half. And they are also claiming they have some numbers involving accidents being related to Ambien use. They are not talking about people taking their sleeping pills & then jumping in their cars a& going for a late night cruise either.

Susie

Wow....my dose dose was 20mg nightly for years. I decided I was tired of being a slave to it, so I came off on my own (w/dr approval) of course.

I hope everyone has to make changes has the success I did!

I just got bumped up to 2 ambien 10mg at night, still can't sleep, usually. I also have Remeron on top of it. Insomnia, as my sig line says, is chronic. I have always had problems with sleep, add uncontrolled pain onto it, and the lack of sleep always affects me more than the affects of Ambien.

This is one of the reasons that people think I'm doped up. I'm not. I'm sleepy. If I find a comfortable position, I tend to get drowsy, which leads to misunderstandings.

Lunesta works for me, but the moldy penny taste that remains in my mouth is far more unacceptable. Tried it for 2 months, and it never went away, as it sometimes does. In fact the taste remained with me for several weeks after I stopped taking it. Yuck.

I have insomia and apnea. Use a cpap. Was taking Trazadol at night to help me rest but they took me off of it due to it drying my mouth out. Sjorgrens has been bad lately. Now I am taking lunesta and it works well. Ambien did not work for me. I too can handle pain better in the day time if I can sleep at night.
I am scheduled for an infusion of Rituxan on Monday . Hoping it will help the arthritis.

Have a question re: forum "how-to's". FDA and MedWatch home page have clarification statements on the new guidelines. It clears up a bit of what the news is reporting but still leaves a lot of questions. Since I am not supposed to include links, how would I pass along this info?

I have looked just about everywhere I can think of trying to locate the actual study data. Can only find the results. If anyone comes across the data for the study, I would appreciate a heads-up. Would be interesting to see how it was collected and over what period of time (sample population size, height, weight, overall health of participant, etc). Came across a couple of interesting studies looking at ambien use with comatose and traumatic brain injury patients (that's just fyi).

This just makes me ill. This decision gives prescribers and insurers another out. I am tired of being punished for another's choices.

s

I am one of those people who CAN NOT take Ambien or Lunesta. I was started on the Ambien and the first couple of nights went well. So I continued taking it and by day 10 I literally was a walking zombie at night.

I would take it at 9 pm and go directly to bed. Like I said the first few nights were ok, then my troubles began. I would go to bed and be asleep when hubby would come to bed. Then he'd hear noise out in the kitchen and he would find me eating out of the garbage pail, YUCK YUCK YUCK.

He had to constantly watch over me, and on the last night I took it, I was seeing things that weren't there. I was biting and scratching him, pulling at the bed covers. He thought I was having a total mental break down, I eventually fell into a deep sleep around 7 am. He went to work took care of urgent stuff and returned home to watch over me. When I woke up I started vomiting every 15 minutes for 8 hours.

The Dr said I had had one of the worse side effects he'd ever seen. I am not allowed anything other than Elavil to help me sleep at night. For me it's hit and miss, I'm on high dose steroids at the moment AND I'm taking Benylsta infusions to treat my lupus, which this drug causes insomina. So I sleep when I can, of course having both Central and obstructive sleep apena I ALWAYS have to go to bed and put my mask on.

If I fall asleep longer than 30 minutes I get into trouble and begin, what hubby calls, my death rattle. Trust me hubby and daughter have a lot of experience with this issue, I've nearly closed the door that I had stepped thru on three different occasions.

I hope that you all remain safe on this drug. I know it's upsetting when the point out someone like Kennedy, but be assured there are MANY folks like me who went to bed and still ended up driving, lighting the house on fire, etc and didn't even know it.

Just my two cents worth.

Hugs,
Barbara

I'm not sure what the "news" stations are reporting, but this is the FDA link:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyalertsforHumanMedicalProducts/ucm334738.htm

From what I have read, current news reports seem a bit slanted. What makes me angry is that people take news reports as gospel. Then you hear, "I told you that those drugs aren't safe...". A lot of experts have a lot to say about something they know nothing about. Would love to hear a news report about the good that some of these drugs offer. If someone gets into a car three hours after taking any sleeping med, is there any outcome other than disaster? The drug is doing exactly what it is supposed to. The person isn't. There are known issues of people doing things in an amnesiac state after taking sedative-hypnotics, so maybe this is what FDA is targeting. Just don't know anymore. Came across a couple of other research reports that sound like they are using what I would call flawed data. One of them was from Feb 2012 that attributed some 40,000 deaths to sleeping meds. Nothing but power grabs.

My sleeping habits are a lot like straydog. Three to four hours a night. Usually an hour at a time. Ambien is the only sleep med I have taken that gives me that small amount. This has been going on for over two years, and is a cycle that none of my providers know how to break. Need a new prior authorization from insurance for ambien. Will see what happens. Had a great part D ins last year but they quit writing at the end of 2012. Made it through the entire year without hitting the donut hole. That was a first.

Good to hear that someone else writes letters. Don't know if they get read or round filed, but if it is important to me, wrong/offensive/ biased, or maybe a darned good job, I'll take the time to let "whoever" know. Am on a first name basis with the secretary at my congressman's office. Sorry to ramble.

Wishing you all good days.
s

Well here you dont get meds put in prescription bottles. They come in the box that the manufactures put them in. And i thought it was a Ambien cus that whats google said. Anyhow, from the top posters saying that its an ingredient is news to me. Thanks again for the info.

The first few times I took it, I had no memory of the night before. I had no idea about the sometimes strange side effects. However, now few months on, it did not do that at all. I had absolutely no morning hang over or anything what so ever. I liked taking it and did help with some of my sleep issues.