FDA requires lowering of Ambien dosage

[discus]

http://health.yahoo.net/news/s/ap/fda-requires-lower-doses-for-sleep-medications

WASHINGTON (AP) — 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 alertness and coordination, 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, Zolpimist and in generic forms. It is the most widely prescribed sleeping aid prescribed in the U.S. The changes don't affect other popular sleeping medicines like Lunesta and Sonata, which use different drugs.

FDA officials pointed out that all sleeping drugs carry warnings about drowsiness.

"All sleep drugs have the potential to cause this, so health professionals should prescribe — and patients should take — the lowest dose that is capable of preventing insomnia," said Dr. Ellis Unger, a director in FDA's Office of Drug Evaluation, on a teleconference with reporters.

Unger added that the FDA will begin requiring developers of sleep drugs to conduct driving simulation studies going forward.

Ambien has been blamed for several recent high-profile driving accidents in the past year, including Tom Brokaw in September and Kerry Kennedy in July.

The FDA has received more than 700 reports of driving-related problems connected to zolpidem over the years.

"But in most cases it was very difficult to determine if the driving impairment was actually related to zolpidem," Unger said. "Usually the reports did not contain information about when the accident happened or how much time had lapsed since taking the drug."

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. The data came from company studies of Intermezzo, a new form of zolpidem which was approved in 2011 for people who wake late at night and can't get back to sleep.

The data showed that 33 percent of women and 25 percent of men taking extended-release zolpidem had enough of the drug in their blood to interfere with driving as much as eight hours later.

When the dose was cut in half only 15 percent of women and 5 percent of men had those same drug levels.

FDA analysis was unable to determine why women metabolize zolpidem so much more slowly than men. According to FDA staff, the difference cannot be accounted for by usual factors like size and weight.

For now, patients should continue taking their currently prescribed dose until they can talk to their doctor about the best way to proceed.

"We really don't want people to change the dose they're on. We want them to talk to their health care provider," Unger said.

Ambien is marketed by Sanofi, Intermezzo by Purdue Pharma LP and Zolpimist by NovaDel Pharma Inc.

[SocialD]

I cut mine in half anyway. It still works great and my supply last longer.

[sky_king]

So, I'm not supposed to take all 5 Ambien that the flight docs give me along with my 3 adult beverages?

[KState_Poke22]

I normally cut them in half as well. Even when I don't though I wake up feeling f*cking great and wide awake.

[brabus]

Great, takes 15 mg to do anything for me...now I have to take 3 pills every time I want to sleep. How is a 10 mg pill making people crash cars presumably 8+ hrs after they took it? I call shenanigans...unless there really are that many people popping ambien and driving a car 4 hrs later.

[Toro]

This won't affect us. I saw a couple of news stories on this, and it sounds like the whole thing is being driven by the actions of idiots (no real surprise), including one woman who took an Ambien in the morning, then crashed her car less than an hour later - she didn't remember any of it. The reports were full of, "Well, no shit" type of information like, "Don't take Ambien if you can't get at least 8 hours of sleep" and "Don't take an Ambien and drive a car."

[Napoleon_Tanerite]

This won't affect us. I saw a couple of news stories on this, and it sounds like the whole thing is being driven by the actions of idiots (no real surprise), including one woman who took an Ambien in the morning, then crashed her car less than an hour later - she didn't remember any of it. The reports were full of, "Well, no shit" type of information like, "Don't take Ambien if you can't get at least 8 hours of sleep" and "Don't take an Ambien and drive a car."

I'm surprised the drug got any scrutiny. It was clearly the evil car that caused the problems. It wasn't the person making the poor decisions or the drugs they are on!

[SuperWSO]

I'm surprised the drug got any scrutiny. It was clearly the evil car that caused the problems. It wasn't the person making the poor decisions or the drugs they are on!

So the solution is ban cars and "High capacity" pill containers. Nobody needs more than 10!

[bronxbomber252]

no, see we aren't completely taking away your rights... since most accidents occur from speeding, we need to ban cars capable of more than 80MPH, since no where has a speed limit above 80!

[Napoleon_Tanerite]

no, see we aren't completely taking away your rights... since most accidents occur from speeding, we need to ban cars capable of more than 80MPH, since no where has a speed limit above 80!

tell me why you NEED a car capable of going over 80mph!

[billy pilgrim]

"High capacity" pill containers. Nobody needs more than 10!

This terrifies me. Just think your neighbors could have these tucked away in their medicine closet and YOU WOULD NEVER KNOW!

[RogAir]

Mark my words, in 10 years the FDA will discover this pill gives you brain cancer. Don't take it....if the USAF can't build a flying schedule that depends on you medicating to make it work--that's their problem (i'm sure they'll compensate you for your brain cancer though)

[Lawman]

Mark my words, in 10 years the FDA will discover this pill gives you brain cancer. Don't take it....if the USAF can't build a flying schedule that depends on you medicating to make it work--that's their problem (i'm sure they'll compensate you for your brain cancer though)

Ill be long dead of some sort of chronic lung disease from spending too much time around Burn Pits and the Poo Pond at Kaf. But yeah you are spot on in the mantra of this isnt the way it should be and us ######ing ourselves up to help it continue isnt fixing the problem.

[KState_Poke22]

Mark my words, in 10 years the FDA will discover this pill gives you brain cancer. Don't take it....if the USAF can't build a flying schedule that depends on you medicating to make it work--that's their problem (i'm sure they'll compensate you for your brain cancer though)

I disagree. Somebody has to fly nights, and when you're coming back to your room when the sun is up to go to bed....sometimes it's difficult to sleep. Especially when you first start that kind of schedule and your circadian rhythm isn't caught up.

[disgruntledemployee]

I disagree. Somebody has to fly nights, and when you're coming back to your room when the sun is up to go to bed....sometimes it's difficult to sleep. Especially when you first start that kind of schedule and your circadian rhythm isn't caught up.

Then submit to the man and pop his pills. Or take action and black out your room and demand a decent bed. Or demand that beer be available as that help people sleep too, and that has been around for many hundreds of years.

If you have to resort to taking sleeping pills to get quality rest, that is fucked up.

Its funny in the sad way that the AF monitors how many pills you get and counsels you if you take the max, yet pushes you to get them. Short story, flight doc on the rotator into AOR announced via plane PA system, "I'll be dispensing Ambien to anyone that wants it since you need to start adjusting to the different time zone."

I've heard folks say that they popped Ambien and were then alerted earlier than planned. I've also seen some whacky shit happen to people on the stuff. Flying like that is dumb.

Out

[Smokin]

Good on that flight doc; getting ambien from some flight docs is like pulling teeth. If you have a fear of ambien, no one is forcing you to take it. I'm pretty sure that the radar dish sitting three feet in front of my family jewels is doing far worse than an occasional ambien anyway.

[brabus]

Good on that flight doc; getting ambien from some flight docs is like pulling teeth.

Flight doc at our last safety meeting gave some talk about how we will not get ambien unless for a specific mission, flight, etc. It was emphasized that any excess ambien not used should be destroyed and any found in our system if blood is drawn because of a mishap could screw us. So, when I have to switch from 10 am briefs to 5 am briefs over a 2 day period, that's not good enough to warrant ambien. We should "adjust our sleep schedule over Sat/Sun." Yeah, because that works. Or I could take ambien for one night and actually be safe to fly a jet vs. sleeping for 3 hrs and then flying a jet, which I will assure anyone is significantly more dangerous than flying 10+ hrs after ambien.

[RASH]

So, when I have to switch from 10 am briefs to 5 am briefs over a 2 day period, that's not good enough to warrant ambien.

You're kidding, right? A 5-hour shift over two days is bad? Not trying to bust your chops here, but there's a big discrepancy between your airframe and mine (what I flew--been retired for a few years) with regards to scheduling.

[Gravedigger]

Non-flyers don't get meds to deal with fucked up schedules; therefore I have about a three-gallon supply of NyQuil. Works like a charm, and no harmful side effects.

I once worked 2200-0700 5 on/2 off for 2 months. It took me about three miserable weeks to adjust to a 0500-1500 schedule after that.

[Spur38]

First they try to take our guns and now regulate our Ambien.....what's next.

[TacAirCoug]

First they try to take our guns and now regulate our Ambien.....what's next.

I don't know, but the day they take my coffee cup will be the day they have to pry it out of my cold dead hand!

[guineapigfury]

Non-flyers don't get meds to deal with fucked up schedules; therefore I have about a three-gallon supply of NyQuil. Works like a charm, and no harmful side effects.

I once worked 2200-0700 5 on/2 off for 2 months. It took me about three miserable weeks to adjust to a 0500-1500 schedule after that.

Yes and non-flyers don't run the risk of killing themselves by flying their desk into the ground. The real solution is to allow alcohol at deployed locations so people can have a nightcap or 8.

[KState_Poke22]

Yes and non-flyers don't run the risk of killing themselves by flying their desk into the ground. The real solution is to allow alcohol at deployed locations so people can have a nightcap or 8.

Ambien will get you much better sleep than alcohol will by far. That being said, I would trade my Ambien for booze in a heartbeat.

[jazzdude]

I got ambien on my last flying deployment as a just in case. Well, I ended up only using 1/5, and figured I'd take back the rest to the flight doc so it could be disposed of properly. Turns out theres no way to get rid of leftover ambien, and they thought I was crazy for trying for having leftover ambien at the end of my tour.

Not a fan of the stuff anymore, and just force myself to time naps/sleep to be good for alert time. I figure if I have to take a sleep aid, the schedule has been messed up for too long.

[Gravedigger]

Yes and non-flyers don't run the risk of killing themselves by flying their desk into the ground. The real solution is to allow alcohol at deployed locations so people can have a nightcap or 8.

Very true, and self-preservation is a compelling reason to want to be alert. I imagine it's a very shitty situation to be in an aircraft alone and fighting to stay awake. Particularly when your ability to accomplish the mission suffers. I don't have any experience with that.

I am not bitching about not getting issued Ambien, perhaps that's how it came off (sts). I am simply stating that in my experience, NyQuil is a lot more safe/effective than prescription meds. It has a lot less latency than Ambien, which I find very important.

You have to be a fairly accomplished drinker to be able to put yourself to sleep quickly without any adverse effects...I have not yet found that balance.