posted
I have not been sleeping more than 3-4 hours for the last year. Before I go completely psychotic my Primary doctor suggested Ambien. I currently take Valium and Elavil for sleep with minimal results.
When I got the prescription filled the insert had a cautionary warning that some people have driven in their sleep or even had sex while on this medication and didn't have any recollection of these incidents.
I am desperate to sleep but not sure if I want to do something and not remember it.
Has this happened to anyone else? Thanks!
Posts: 425 | From NY, United States | Registered: Mar 2005
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posted
I've never had any ill effects from Ambien .... and it works for me. The Ambien CR didn't work very well for me, but the regular kind did. In the beginning I'd take half of one when I went to bed, then half when I woke up a few hours later.
Now I'm getting by on only the half before I go to bed.
-------------------- sixgoofykids.blogspot.com Posts: 13449 | From Ohio | Registered: Feb 2007
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Keebler
Honored Contributor (25K+ posts)
Member # 12673
EXCERPT: The review was prompted, in part, by queries to the agency from The New York Times last year, (after)
after some users of the most widely prescribed drug, Ambien, started complaining online and to their doctors about unusual reactions ranging (from)
from fairly benign sleepwalking episodes to hallucinations, violent outbursts, nocturnal binge eating and -- most troubling of all -- driving while asleep.
--------------------------
F.D.A. WARNS OF SLEEPING PILLS' STRANGE EFFECTS
Ambien and Lunesta are among the 13 sleep medications that the F.D.A. has ordered to use strong new label warnings.
By STEPHANIE SAUL March 15, 2007
The most widely prescribed sleeping pills can cause strange behavior like driving and eating while asleep, the Food and Drug Administration said yesterday, announcing that strong new warnings will be placed on the labels of 13 drugs.
The agency also ordered the makers of the well-known drugs Ambien and Lunesta and the producers of 11 other commonly used sleeping pills to create patient fliers explaining how to use them safely.
The fliers, which the agency says it requires when it sees a significant public health concern, will be handed out at pharmacies when consumers fill their prescriptions. Although the agency says that problems with the drugs are rare, reports of the unusual side effects have grown as use of sleeping pills has increased.
Sales in the United States of Ambien and Lunesta alone last year exceeded $3 billion. Use of those medications and other similar drugs has soared by more than 60 percent since 2000, fueled by television, print and other advertising. Last year, makers of sleeping pills spent more than $600 million on advertising aimed at consumers.
The review was prompted, in part, by queries to the agency from The New York Times last year, after some users of the most widely prescribed drug, Ambien, started complaining online and to their doctors about unusual reactions ranging from fairly benign sleepwalking episodes to hallucinations, violent outbursts, nocturnal binge eating and -- most troubling of all -- driving while asleep.
Night eaters said they woke up to find Tostitos and Snickers wrappers in their beds, missing food, kitchen counters overflowing with flour from baking sprees, and even lighted stoves.
Sleep-drivers reported frightening episodes in which they recalled going to bed, but woke up to find they had been arrested roadside in their underwear or nightclothes. The agency said that it was not aware of any deaths caused by sleep-driving.
The reports gained credence from scientific studies. A forensic toxicologist in Wisconsin, Laura J. Liddicoat, gave a presentation at a national meeting on six instances of Ambien-impaired driving.
And Dr. Carlos H. Schenck and Dr. Mark W. Mahowald of the University of Minnesota said that they had been studying cases of nearly 30 Ambien users who developed unusual nighttime eating disorders.
Last May in Washington, Rep. Patrick Kennedy, Democrat of Rhode Island, blamed Ambien when he crashed his car near the Capitol building.
The agency also received reports of people making phone calls, purchasing items over the Internet, or having sex under the influence of sleep medication.
In each case the consumers had no recollection of the events, which they said had occurred after they took their pills and headed for bed.
An agency official said yesterday that the activities associated with the drugs went beyond mere sleepwalking. "We do believe that sleepwalking is different from these behaviors," said Dr. Russell Katz, the F.D.A.'s director for neurology products. "Sleepwalking is considered more of a reflex.
These behaviors are complex and they're different fundamentally because of the complexity. People get up, they take their car keys and they go drive. As you might imagine, that might be potentially dangerous to the patient and others as well."
Dr. Katz said that it was not entirely clear whether people reporting the problems had been technically asleep or awake.
Although Dr. Katz said the side effects were rare, the agency said that the few dozen reports it had received probably did not represent the full extent of the problem.
Drinking alcohol before or after taking the drugs appears to increase the chances of having such a reaction, Dr. Katz said. A defense lawyer in Atlanta who specializes in impaired-driving cases, William C. Head, said he had received calls from people around the world who had been charged after using such medications.
"Ninety percent of these cases involve alcohol as well," Mr. Head said. Often, though, the people arrested had only a glass of wine or two, then took a sleeping pill, he said.
"You can't even keep your car on the road," Mr. Head said. "I think any warnings that they give, any advertisements should say not a drop of alcohol."
The medication guides that the agency has called for will clearly explain that risk, according to Dr. Katz, who said the drug makers must submit drafts by May.
He said the drug makers had been working with the F.D.A. on the wording since the agency notified the companies three months ago that the changes would occur.
Besides warning against alcohol use, the new labels and guides will tell consumers that they should not take the pills with other drugs that suppress the nervous system.
The warnings labels will include some general language required by the agency, along with language that the companies will be required to draft that describes the side effects of their specific drugs.
The drugs affected include newer products as well as older and widely used ones that are sold under brand names and generic names.
Most of the drugs already carry statements warning against alcohol use and of the risk of hallucinations. Advertising for the drugs has also included such warnings. But the labels will make those statements more prominent, and the medication inserts will emphasize the risks when the consumer gets the prescription filled.
The warnings also are to include information about an unrelated and rare risk of life-threatening allergic reactions with sleep medications.
Some patients have recently reported such reactions, in which the air passages or face swells up, after using one of the newest drugs in the group, Rozerem, Dr. Katz said.
After reviewing reports, the agency determined that those reactions were also a potential side effect with other drugs in the group, he said.
Although most of the reports of sleep-driving and sleep-eating have involved Ambien, the agency concluded that the behavior can be caused by any of the sleeping pills.
One sleep expert, Dr. Mahowald of Minnesota, said that Ambien had received the most publicity because it was the most widely used. But "there's no question that any of the sedative hypnotics can do this," he said.
Ambien and its extended-release formula, Ambien CR, made by Sanofi-Aventis, dominated the market last year, accounting for 27.6 million of the 44 million sleep drug prescriptions in this country, according to data from Verispan. In second place, with about 7.3 million prescriptions, was the drug temazepam, a generic that is also sold by Tyco Healthcare under the brand name Restoril.
Lunesta, by Sepracor, was next with 5.8 million prescriptions. Dr. Mahowald directs the Minnesota Regional Sleep Disorders Center, where doctors have been involved in a study of about 30 patients who developed sleep-eating while using Ambien. Some of the patients gained weight before discovering that they were getting up at night to cook and eat.
"Hopefully this will make doctors think twice before blindly giving patients a prescription," said Dr. Mahowald, who advocates a combination of medication and behavioral therapy to treat insomnia.
He also criticized marketing of the products. "I personally think the extent of advertising has just been unconscionable," he said. Data from the research firm TNS Media Intelligence shows that in 2005 and 2006, Sanofi-Aventis spent a total of nearly $350 million to advertise Ambien and Ambien CR.
Sepracor spent more than $500 million on advertising for Lunesta during that same two-year period. And Takeda, which makes Rozerem, spent about $100 million.
After yesterday's F.D.A. announcement, Sanofi-Aventis immediately posted the text of a "Dear Doctor" letter to its Web site, outlining the new warnings.
The agency has ordered all the companies to send such advisories to prescribing doctors.
In a statement last night, Sanofi-Aventis said that information about sleepwalking had always been included on its label. In company clinical studies, it occurred in fewer than 1 in 1,000 patients, the statement said.
The agency also said that it was recommending that the drug makers conduct additional clinical studies involving sleep-driving and other reactions to determine whether any of the sleeping pills do not cause those problems.
But those studies will not be required. And so far, none of the companies have announced plans to conduct them, Dr. Katz said.
The agency's move follows a warning last month by authorities in Australia, where Ambien is marketed as Stilnox.
The Australian drug agency said that it had received 16 reports of unusual activities by consumers using the product, including sleep-driving and sleep-eating. In one case, a woman woke up with a paintbrush in her hand, discovering she had painted the front door of her home while asleep.
posted
Thanks Keebler for the report. I am not taking it and will look for something else for my insomnia.
No warning was given to me by the pharmacy where I had the prescription filled.
Posts: 425 | From NY, United States | Registered: Mar 2005
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posted
I am always skeptical about taking medicines such as this
but I have been taking generic Ambien for about a month now and I have not had any major problems.
I only take 1/2 a pill, though, and I am usually asleep within 15-25 minutes.
Some mornings I do wake up with a headache, but that has been the only negative effect:(
I was told the medicine loses effectiveness if taken every night, but that has not happened to me yet.
Posts: 209 | From maryland | Registered: Aug 2007
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Keebler
Honored Contributor (25K+ posts)
Member # 12673
posted
-
I took this about 8 or 10 years ago when living in the middle of a noisy city. At first it was my new best friend.
but, then, no warning about four hours after taking it, I would literally spring from deep sleep to an upright position just like some crash-test dummy. So wide awake then, and no going back to sleep for sure as I was in shock. Very odd reactions. It took me a while to make a connection.
There is much more about this in the way of side effects, even whole groups forming to help others get over it. However, ambien can buy up all the web sites with that name and so, when googled by the name, the other sites may not pop up.
It's happened with other drugs, too. The proprietary name sites restrict the flow of other information.
We are not getting all the news even if we think we are doing a search.
again, as with all meds, some people may do fine. Some may not. Weigh the risks
posted
I have found Ambien to be great. The only side effect I've noticed is that if I take a whole pill each night for several weeks, I notice I'm a bit more depressed.
So I stick to 1/2 pill most of the time. Still works very well. I haven't done anything weird while on it.
I've taken it off and on for 3-4 yrs. I also have never had trouble going off of it, so it's not addictive in my opinion.
-------------------- --Lymetutu-- Opinions, not medical advice! Posts: 96222 | From Texas | Registered: Feb 2001
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