With a tendency to stare zombie-like and run into stationary objects, a new species of impaired motorist is hitting the roads: the Ambien driver.
The presentation refers to Zolpidem, which is the chemical name for Ambien. Ambien, the nation's best-selling prescription sleeping pill, is showing up with regularity as a factor in traffic arrests, sometimes involving drivers who later say they were sleep-driving and have no memory of taking the wheel after taking the drug.
In some state toxicology laboratories Ambien makes the top 10 list of drugs found in impaired drivers. Wisconsin officials identified Ambien in the bloodstreams of 187 arrested drivers from 1999 to 2004.
And as a more people are taking the drug — 26.5 million prescriptions in this country last year — there are signs that Ambien-related driving arrests are on the rise. In Washington State, for example, officials counted 78 impaired-driving arrests in which Ambien was a factor last year, up from 56 in 2004.
Ambien's maker, Sanofi-Aventis, says the drug's record after 13 years of use in this country shows it is safe when taken as directed. But a spokeswoman, Melissa Feltmann, wrote in an e-mail message, "We are aware of reports of people driving while sleepwalking, and those reports have been provided to the U.S. Food and Drug Administration as part of our ongoing postmarketing evaluation about the safety of our products."
A spokeswoman for the F.D.A. said the drug's current label warnings, which say it should not be used with alcohol and in some cases could cause sleepwalking or hallucinations, were adequate. "People should be aware of that," said the spokeswoman, Susan Cruzan.
While alcohol and other drugs are sometimes also involved in the Ambien traffic cases, the drivers tend to stand out from other under-the-influence motorists. The behavior can include driving in the wrong direction or slamming into light poles or parked vehicles, as well as seeming oblivious to the arresting officers, according to a presentation last month at a meeting of forensic scientists.
"These cases are just extremely bizarre, with extreme impairment," said Laura J. Liddicoat, the forensic toxicology supervisor at a state-run lab in Wisconsin who made the presentation.
Her presentation, which reported on six of the cases, was made at a meeting of the American Academy of Forensic Sciences, where her counterparts from other parts of the country swapped similar tales.
Several of Ms. Liddicoat's cases involved drivers whose blood revealed evidence of Ambien overdoses. In one of them the driver, who was also taking the antidepressant citalopram, crashed into a parked car, was involved in another near collision, then drove over a curb. When confronted by police, he did not recall any of the recent events, according to the presentation.
Ms. Liddicoat did not describe any of those cases as sleep-driving — in fact, she said she had not heard of that defense — and it is possible that some drivers' claims of driving while asleep may be mere Ambien alibis. But some medical researchers say reports of sleep-driving are plausible.
Doctors affiliated with the University of Minnesota Medical Center who have studied Ambien recently reported the cases of two users who told doctors they sleep-drove to the supermarket while under the drug's influence. Neither of the patients remembered the episode the next day, according to Dr. Carlos Schenck, an expert in sleep disorders who is the lead researcher in the study.
"Luckily, neither of them got hurt," said Dr. Schenck, who added that sleep-driving — which really occurs in a twilight state between sleep and wakefulness — was more common than people generally suspect. He said he believed that Ambien was an excellent sleep agent, but that patients need to be better warned about its potential side effects.
The traffic cases around the country include that of Dwayne Cribb, a longtime probation and parole officer in Rock Hill, S.C. Mr. Cribb says he remembers nothing after taking Ambien before bed last Halloween — until he awoke in jail to learn he had left his bed and gone for a drive, smashed into a parked van and driven away before crashing into a tree. Mr. Cribb is still facing charges of leaving the scene of an accident.
A registered nurse who lives outside Denver took Ambien before going to sleep one night in January 2003. Sometime later — she says she remembers none of the episode — she got into her car wearing only a thin nightshirt in 20-degree weather, had a fender bender, urinated in the middle of an intersection, then became violent with police officers, according to her lawyer.
The woman, whose lawyer says she previously had a pristine traffic record, eventually pleaded guilty to a reduced charge of careless driving after the prosecutors partly accepted her version of events, said the lawyer, Lloyd L. Boyer.
bigpedaler
03-14-07, 08:58 PM
OK, now i have a real reason to ride the damned sidewalk!
better living through chemistry, eh? bullllll-sh**********t ! ! !
sbhikes
03-14-07, 09:01 PM
I hear that my lane position can control motorist outcome. I'll try that next time someone is sleep-driving toward me. See how I fare.
deputyjones
03-14-07, 09:04 PM
Ambien is just the tip of the iceberg. There are more mind-altering medications in today's drivers than I can count for anything from psychosis to heart conditions and everything in between. I see it all the time, and it is tough to enforce because the burden of proof is on me to prove that their "intoxication" substantially affects their driving and they don't have to tell me what they are taking (5th amendment).
I can also request that the Secretary of State re-test them, but then they just quit taking whatever drug that is effecting them for a few days before the test.
A society dependent on cars and pills is not good.
deputyjones
03-14-07, 09:05 PM
I hear that my lane position can control motorist outcome. I'll try that next time someone is sleep-driving toward me. See how I fare.
:roflmao:Would that make you purely responsible for you safety?
sbhikes
03-14-07, 09:06 PM
A society dependent on cars and pills is not good.
You can say that again.
I-Like-To-Bike
03-14-07, 09:11 PM
I hear that my lane position can control motorist outcome. I'll try that next time someone is sleep-driving toward me. See how I fare.
Steely Eyed AlphaDawgs vs the Sleeping Pill Zombies, Wow! Yeah, that will be like Godzilla vs. Megalon. Pass the popcorn.
RomSpaceKnight
03-14-07, 11:08 PM
I took sleeping pils a couple of times in hospital to ensure a good nights sleep before surgery. They did seem to last longer than 8 hrs. I could still feel their effects 10 hours after taking them. I actually fell asleep before the anesthetic went in to me.
fordfasterr
03-15-07, 05:39 AM
...
A society dependent on cars and pills is not good.
Tell that to the Walgreens and CVS'es of the world !
I-Like-To-Bike
03-15-07, 06:57 AM
I took sleeping pils a couple of times in hospital to ensure a good nights sleep before surgery. They did seem to last longer than 8 hrs. I could still feel their effects 10 hours after taking them. I actually fell asleep before the anesthetic went in to me.
Was that a problem?
bigpedaler
03-15-07, 08:00 AM
I took sleeping pils a couple of times in hospital to ensure a good nights sleep before surgery. They did seem to last longer than 8 hrs. I could still feel their effects 10 hours after taking them. I actually fell asleep before the anesthetic went in to me.
i was given a scrip for muscle relaxers a couple years ago for my low back; they are so potent, i can't take them the night before work or any day i have things to do before about noon. most of the time, when i DO have to take one, i cut it in half, and i still sleep like the dead. NO WAY would i try to drive with that in my system.
for these multi-tasking yahoos who think the only way to live life is burn the candle at both ends, i can only say, "grow up -- he who dies with the most toys DOES NOT WIN, he just DIES."
DataJunkie
03-15-07, 08:09 AM
My wife takes ambien. No sleep driving episodes yet.
She does wander aimlessly from time to time, walks outside in freezing weather, eats, relocates strange items in our house, and a few other items all while sleeping. The combination of the other meds she is on cause quite a bit of issues with her ability to sleep.
SingleSpeeDemon
03-15-07, 08:15 AM
I had a really crazy Ambien experience, but I only dicuss it with trusted friends in private.
Or to anyone who'll buy me a beer.
I-Like-To-Bike
03-15-07, 08:20 AM
i was given a scrip for muscle relaxers a couple years ago for my low back; they are so potent, i can't take them the night before work or any day i have things to do before about noon. most of the time, when i DO have to take one, i cut it in half, and i still sleep like the dead. NO WAY would i try to drive with that in my system.
Maybe just a different medication would have served the purpose without the sleepy time side effects. I had one prescription (can't remember the name of it) for muscle relaxer that affected me in the same way as yours; changed to 5 mg Diazepin (Valium) when scar tissue from 3 different back operations acts up and have had no problem with fatigue or unwanted drowsiness since.
N_C
03-15-07, 08:21 AM
As a person with a sleeping disorder I can tell you sleep aids are not the answer. I have sleep apnea, I have to use a CPAP to sleep at night. Prior to getting the CPAP I had to undergo a sleep study. Before that the dr. had no idea why I wan't getting the restfull sleep I needed. I went through all other tests prior to the sleep study it all came back negative.
I think dr.'s are prescribing the sleep aids, in this case ambien, far too often with out having a sleep study done.
There are more then one type of sleeping disorders. Some keep you from falling asleep & turning off at the end of the day others, APNEA, prevent you from getting the full nights rest you need.
I wish dr.'s would not jump the gun so much & just blindly prescribe pills as a fix all. For those that have dr's that do this, please do not abuse this or find another dr. who will not do this. Pills are not always the answer & in most cases only treat the symptoms, not the cause.
I doubt Ambien treats the reason people can not fall asleep. It only causes them to fall asleep by making them drowsy.
slowandsteady
03-15-07, 08:28 AM
OK, now i have a real reason to ride the damned sidewalk!
better living through chemistry, eh? bullllll-sh**********t ! ! !
We are talking about a handful of people out of the millions that take it. What about the risk insomniacs pose when they haven't slept for three weeks? What are those odds? Also these people in question were taking multiple sedatives, including alcohol, at the same time which is NOT what is recommended by the doctor or drug companies.
Also, as disconcerting as this news is, it may not be as bad as you think. I am not a neurologist so I can't explain the details, but I do know that we are able to perform complicated tasks while not committing things to memory. Just because you don't remember doing something doesn't mean you weren't totally alert and capable of performing that task. This MAY have been what happened at least in some of the cases.
slowandsteady
03-15-07, 08:35 AM
As a person with a sleeping disorder I can tell you sleep aids are not the answer. I have sleep apnea, I have to use a CPAP to sleep at night. Prior to getting the CPAP I had to undergo a sleep study. Before that the dr. had no idea why I wan't getting the restfull sleep I needed. I went through all other tests prior to the sleep study it all came back negative.
I think dr.'s are prescribing the sleep aids, in this case ambien, far too often with out having a sleep study done.
There are more then one type of sleeping disorders. Some keep you from falling asleep & turning off at the end of the day others, APNEA, prevent you from getting the full nights rest you need.
I wish dr.'s would not jump the gun so much & just blindly prescribe pills as a fix all. For those that have dr's that do this, please do not abuse this or find another dr. who will not do this. Pills are not always the answer & in most cases only treat the symptoms, not the cause.
I doubt Ambien treats the reason people can not fall asleep. It only causes them to fall asleep by making them drowsy.
There can be many reasons why a person cannot sleep and many of them are treatable. I used to have problems falling asleep. I also drank a pot of coffee to stay awake. I had to take sleeping pills to fall asleep. It was a viscious cycle. I gave up coffee. It was a hellish two weeks, but in the end I was able to sleep well, get up refreshed, and my migraines all but disappeared. I also had heart palpitations that went away too. I drink coffee again, but limit it to two cups in the morning only.
Some people have psychological reasons and these need to be addressed. Sleeping pills should be a temporary fix. Once you get into a rut of insomnia it can be very hard to get out of without some medical help. People develop an anxiety about falling asleep that prevents them from falling asleep. This is on top of the reason they couldn't fall asleep in the first place. They can't win. But sleeping pills should only be for a few weeks until the real problem is fixed and they have a few positive experiences falling asleep without anxiety.
Bikepacker67
03-15-07, 05:22 PM
We are talking about a handful of people out of the millions that take it.
No. It's actually more like 1 in 100... and given that there are something like 20 million prescriptions, that's alot of zombies with the potential to get behind the wheel.
Bikepacker67
03-15-07, 05:44 PM
I had a really crazy Ambien experience, but I only dicuss it with trusted friends in private.
Or to anyone who'll buy me a beer.
Have an e-beer...
http://www.beersweetbeer.com/images/mousehome.jpg
skanking biker
03-15-07, 05:47 PM
With a tendency to stare zombie-like and run into stationary objects, a new species of impaired motorist is hitting the roads: the Ambien driver. .
My guess is that ambien will be the next big drug that product liability lawyers will go after.
John E
03-15-07, 08:09 PM
My guess is that ambien will be the next big drug that product liability lawyers will go after.
If someone sleep-drives, should we blame that individual, the drug maker, or both? This new road hazard is not to be taken lightly. If sleep-driving really is occurring, Ambien/Lunesta/whatever users need to be warned to put their car keys in a hard-to-reach space, such as in a locked drawer.
sbhikes
03-15-07, 08:29 PM
My wife takes ambien. No sleep driving episodes yet.
She does wander aimlessly from time to time, walks outside in freezing weather, eats, relocates strange items in our house, and a few other items all while sleeping. The combination of the other meds she is on cause quite a bit of issues with her ability to sleep.
I hope you lock up the car keys before bed time!
Doesn't it seem like the rise in all these prescription sleep aids corresponds to the increase in Starbucks franchises?
Bikepacker67
03-15-07, 09:58 PM
How much does ambian cost?
A years worth must be more than the price of an entry level comfort bike.
And I think the bike would solve more sleep problems than the pill.
donnamb
03-15-07, 10:32 PM
How much does ambian cost?
A years worth must be more than the price of an entry level comfort bike.
And I think the bike would solve more sleep problems than the pill.
+1. My brother and I have no car so my mom has been riding a bike with us while she's been visiting. Guess what? She goes right to sleep and stays that way. I'm certainly not suggesting that is the cure for all sleep problems, but it sure wouldn't hurt to give it a try.
About the Ambien - the psychiatrists and nurse practitioners where I work are alarmed enough about this 1 in 100 weirdness that they've pretty much stopped prescribing it altogether.
skanking biker
03-15-07, 10:33 PM
If someone sleep-drives, should we blame that individual, the drug maker, or both? This new road hazard is not to be taken lightly. If sleep-driving really is occurring, Ambien/Lunesta/whatever users need to be warned to put their car keys in a hard-to-reach space, such as in a locked drawer.
Its not about who we blame--its about who has the money
slowandsteady
03-16-07, 08:36 AM
No. It's actually more like 1 in 100... and given that there are something like 20 million prescriptions, that's alot of zombies with the potential to get behind the wheel.
That is flat out not true or even close. There are 19 cases out of 24 million prescriptions for Ambien. And Ambien is connected with 19 out of 48 TOTAL cases. That is a percentage so low you need a negative exponent. I don't even know if it is statisically significant.
slowandsteady
03-16-07, 08:40 AM
How much does ambian cost?
A years worth must be more than the price of an entry level comfort bike.
And I think the bike would solve more sleep problems than the pill.
You are probably right. The problem is that doctors spend all of 5 minutes with their patients. They hear insomnia and they prescribe a pill when they should be asking:
How much coffee do you drink?
How late in the day do you drink coffee?
What are the stresses in your life?
Do you give yourself at leat 9 hours in which to sleep?
What is your normal routine?
Do you work shift work?
Do you exercise regularly?
etc...
skanking biker
03-16-07, 08:42 AM
Silly me---I just realized:
ambien treats insomnia
You know what they say--a soma a day keeps the doctors away!
Bikepacker67
03-16-07, 09:21 AM
That is flat out not true or even close. There are 19 cases out of 24 million prescriptions for Ambien. And Ambien is connected with 19 out of 48 TOTAL cases. That is a percentage so low you need a negative exponent. I don't even know if it is statisically significant.
No no no... there may have been only 19 cases where the zombies were caught on the road, but the incidence of sleep walking/eating/etc is far more prevalent with these drugs.
slowandsteady
03-18-07, 08:49 AM
If someone sleep-drives, should we blame that individual, the drug maker, or both? This new road hazard is not to be taken lightly. If sleep-driving really is occurring, Ambien/Lunesta/whatever users need to be warned to put their car keys in a hard-to-reach space, such as in a locked drawer.
The patient, since the warnings on the insert and bottle both say to not combine certain meds or alcohol. These people in question ignored that and did what they wanted. It isn't the doctor's fault or the drug company's fault when people abuse the drug and get drunk off of half a dozen other things too despite warnings to the contrary.
slowandsteady
03-18-07, 08:50 AM
No no no... there may have been only 19 cases where the zombies were caught on the road, but the incidence of sleep walking/eating/etc is far more prevalent with these drugs.
Show me the source.
dynodonn
03-18-07, 09:04 AM
How much does ambian cost?
A years worth must be more than the price of an entry level comfort bike.
And I think the bike would solve more sleep problems than the pill.
I agree, I don't dare let my head touch any pillow until I'm ready for Z time. ;)
Bikepacker67
03-18-07, 09:55 AM
Show me the source.
How Many Ambien Patients Get Up At Night And Remember Nothing? (http://www.medicalnewstoday.com/medicalnews.php?newsid=39759)
Reports are growing of patients taking insomnia medication Ambien, getting up at night, eating loads of food, going back to bed, and remembering nothing of the event next morning.
Sanofi-Aventis' Ambien is the most popular drug in the world for people who suffer from insomnia. In the USA alone, 11 billion nights' worth of Ambien are consumed each year. 30 million people in the USA take sleep medications - a nearly 50% increase since 2000.
Perhaps this increase in the consumption of sleep medication may explain the rise in the number of people reporting this bizarre side-effect.
Sanofi-Aventis says sleepwalking is a very rare side effect of Ambien. However, as the company has no statistics on sleepwalking it is unlikely to know how rare the event really is.
There have also been more patients reporting short-term memory loss. A rising number of patients are getting up in the morning, still feeling the effects of the drug, getting behind the wheel and crashing their vehicles.
Many experts say patients, especially in the USA, are using drugs for insomnia for longer than they should.
Drugs for insomnia are heavily advertised in the USA, where it is allowed to target prescription drugs adverts at patients.
How common these problems of sleepwalking and short-term memory loss are is difficult to know. The FDA's reporting system is done on a voluntary basis.
Doctors stress that a patient should not stop taking Ambien abruptly, the process has to be gradual, otherwise there are risks of serious problems, including seizures.
At Medical News Today we are flooded with patientss opinions on Ambien and Lunesta. The main theme seems to be that doctors try to get their patients off Ambien because of dependency - but many patients don't like the metallic aftertaste of Lunesta.
Written by: Christian Nordqvist
Editor: Medical News Today
(How convenient for Sanofi-Aventis that they don't keep records, eh?)
----------------------------------------------------------------------
Ambien sleepwalking is rife - Opinion
posted by Dr. Arnold Swathier on 20 Mar 2006 at 6:05 am (http://www.medicalnewstoday.com/youropinions.php?opinionid=8726)
I have lots of patients on Ambien. At least half experience either sleepwalking, memory loss or problems driving.
For the makers to say these side-effects are rare, is a joke!!!
Ambien users wake up, smell the lawsuits (http://www.wislawjournal.com/archive/2006/0426/ambien.html)
Bikepacker67
03-18-07, 10:10 AM
Ambien Forces Married Couple to Sleep in Same Bed (http://www.scienceofapathy.com/2007/03/15/ambien-forces-married-couple-to-sleep-in-same-bed/)March 15th, 2007 by Brian
George T. Wallace is a 54 year old RV salesman from Mount Prospect Illinois. For 30 years his wife Joette and himself have been happily married and eagerly awaiting retirement. It may come as a surprise to many that these two love birds enjoy separate bedrooms. Joette’s frequent insomnia and George’s chronic snoring and various gastro-intestinal problems fostered an unpleasant relationship once the lights went off each night. Once the kids grew up and moved out the couple forged an agreement that revitalized their marriage.
“I get the master bedroom and George sleeps in our son’s old room. During the day we’re more rested and even-tempered.” Joette told us.
The Wallaces’ agreement is not an unusual one. At Escala, a condominium project in Seattle, a quarter of the 270 units have double master bedrooms, said John Midby, a partner in the development. In St. Louis County, Dennis Hayden, president of Hayden Homes, said that each of the 30 detached homes in his latest planned community would have two separate-but-equal bedroom suites.
Problems started occurring when Joette started taking the popular sleep aid Ambien for her insomnia. Sometimes she would wake up to find cheese slice wrappers in bed with her. One morning she discovered that someone had cooked and eaten an entire package of smoked sausage in the night. It didn’t take much sleuthing to find a single half-eaten sausage in the pocket of her nightgown. The last straw came one morning when George made an off-color remark about Joette’s lust-filled visit to his bedroom the previous night. He later confessed that “I honestly didn’t notice that she was asleep.”
This incident leads some FDA regulators to believe that 90% of “sleep sex” as a result of Ambien goes unreported in the 50-65 age group.
The FDA has announced that stronger warnings need to be placed on the warning labels of popular sleep aid medications such as Ambien and Lunesta. The full story is over at the New York Times.
donnamb
03-18-07, 11:57 AM
The full story is over at the New York Times.
Here it is (http://www.nytimes.com/2007/03/15/business/15drug.ready.html?ex=1174881600&en=de3d9f034a97935d&ei=5070). I can't post the multimedia graphics, just the text.
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.
bigpedaler
03-18-07, 03:36 PM
Maybe just a different medication would have served the purpose without the sleepy time side effects. I had one prescription (can't remember the name of it) for muscle relaxer that affected me in the same way as yours; changed to 5 mg Diazepin (Valium) when scar tissue from 3 different back operations acts up and have had no problem with fatigue or unwanted drowsiness since.
this one was for when it got real bad -- i have a daily maintenance scrip for the strongest NSAID there is -- no drowsiness w/ it, either. i was told the only thing they could give me that was stronger was vicodin, and i've had that sh**. dehydration for a m-f!
lima_bean
03-18-07, 04:08 PM
I have problems with sleep walking in extreme ways as well, and I dont take any drugs of any kind. Ive heard of sleep driving before from people who are not on drugs.
G60
03-18-07, 06:17 PM
ambien is insane. that stuff scares the crap out of me. my g/f was prescribed it because another of her medications causes insomnia.
twice she has gone into a state of pretty much 'dreaming while awake'. she'll be awake, but completely unresponsive to any other people, while seeing strange things. she'll claim to see and hear other people in the room, have double or triple vision, lose muscle control (one time she just collapsed and couldn't stand up again), all sorts of really creepy stuff, but normal if you're dreaming!
the first time it happened i had NO idea what was going on (did not know she had taken ambien that night) and was about to take her to the ER. i called one of our friends who is a pharmacy tech, and she explained it was either her Ambien or Lamictal she was recently prescribed.
i've come to the conclusion if you don't get to sleep or are forced to stay awake after taking ambien, it can put you into a dream-state. perhaps this is what's happening to some of these people. i do believe there is a warning that says 'do not take ambien, etc, until you are completely ready to go to bed.
G60
03-18-07, 06:22 PM
How much does ambian cost?
A years worth must be more than the price of an entry level comfort bike.
And I think the bike would solve more sleep problems than the pill.
costs $60/year under my g/f's insurance.
i don't see how riding a bike will cure anti-seizure med related insomnia. not everybody is on these medications just because it's the 'thing to do'
get off your a&s soapbox :rolleyes:
donnamb
03-18-07, 08:02 PM
i don't see how riding a bike will cure anti-seizure med related insomnia. not everybody is on these medications just because it's the 'thing to do'
You're absolutely correct, G60. I think that it's easy to misunderstand what people are saying on a thread like this in part because of the misconceptions people develop about certain prescription meds - because of all that TV and magazine advertising. If all you knew about these meds was from the commercial ads, you'd think Ambien, et al, is primarily prescribed to people who are way too stressed, and lead otherwise unhealthy lifestyles, hence their sleep disorders.
I work in a community mental health clinic where they were prescribing Ambien for the side effects of several psychiatric drugs that cause sleeplessness, so I totally know what you mean about your girlfriend. Thanks for reminding us that while many of these new drugs are completely overprescribed, there are people for whom they are a miracle, in spite of the scary side effects.
jhumason
03-18-07, 08:41 PM
You're absolutely correct, G60. I think that it's easy to misunderstand what people are saying on a thread like this in part because of the misconceptions people develop about certain prescription meds - because of all that TV and magazine advertising. If all you knew about these meds was from the commercial ads, you'd think Ambien, et al, is primarily prescribed to people who are way too stressed, and lead otherwise unhealthy lifestyles, hence their sleep disorders.
I work in a community mental health clinic where they were prescribing Ambien for the side effects of several psychiatric drugs that cause sleeplessness, so I totally know what you mean about your girlfriend. Thanks for reminding us that while many of these new drugs are completely overprescribed, there are people for whom they are a miracle, in spite of the scary side effects.Thanks for this post. My wife was prescribed Ambien for quite a while for just the reasons stated here. It worked well for her. But her health insurance provider removed it from their list of approved drugs, so she was switched to their "approved replacement" (i.e.: much cheaper) drug, Tamazepam. Perhaps coincidentally, this happened about the time Ambien began to be promoted heavily on TV ads. The replacement did not perform nearly as well as the Ambien, and my wife suffered from many sleepless nights after the switch.
She did have some "sleep eating" issues with the Ambien, although nothing very extreme...a candy bar wrapper here and there for example. No driving incidents, and (sadly for me ;) ) no sleep sex incidents either.
Since then she has been taken off all of her psychiatric medications, and no longer needs the sleeping pills. But Ambien really was a benefit for her.
Bikepacker67
03-18-07, 09:46 PM
twice she has gone into a state of pretty much 'dreaming while awake'. she'll be awake, but completely unresponsive to any other people, while seeing strange things. she'll claim to see and hear other people in the room, have double or triple vision, lose muscle control (one time she just collapsed and couldn't stand up again), all sorts of really creepy stuff, but normal if you're dreaming!
How is this different than a full blown psychotic episode?
I think it's a mistake to assume that these people are just "sleeping". They're in some sort of consciousness where they have some sense of what is around them (walls, fridge doors, car keys) but at the same time experiencing hallucinations.
What is the most important information I should know about zolpidem?
• Zolpidem will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.
• You may be more likely to have amnesia (forgetfulness) if you cannot get a full 7 to 8 hours of sleep after taking zolpidem. You may also be at an increased risk of accident or injury if you attempt to drive or operate machinery after taking zolpidem without having enough sleep time afterward.
• Zolpidem can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
• Do not drink alcohol while you are taking zolpidem. It can increase some of the side effects of zolpidem, including drowsiness.
• Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).
• You may have withdrawal symptoms if you stop taking zolpidem after taking it over several days in a row. Do not stop taking zolpidem suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.
• Zolpidem may be habit-forming and should be used only by the person it was prescribed for. Zolpidem should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
What is zolpidem?
• Zolpidem is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).
• Zolpidem is used to treat insomnia. This medication causes relaxation to help you fall asleep and stay asleep.
• Zolpidem may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking zolpidem?
• Do not use this medication if you are allergic to zolpidem. Zolpidem tablets may contain lactose. Use caution if you are sensitive to lactose.
• Zolpidem will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.
• You may be more likely to have amnesia (forgetfulness) if you cannot get a full 7 to 8 hours of sleep after taking zolpidem. You may also be at an increased risk of accident or injury if you attempt to drive or operate machinery after taking zolpidem without having enough sleep time afterward.
• Before taking zolpidem, tell your doctor if you are allergic to any drugs, or if you have:
· kidney disease;
· liver disease;
· lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary pulmonary disease (COPD);
· a history of depression, mental illness, or suicidal thoughts; or
· a history of drug or alcohol addiction.
• If you have any of these conditions, you may not be able to use zolpidem, or you may need a dosage adjustment or special tests during treatment.
• FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
• Zolpidem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
• The sedative effects of zolpidem may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking zolpidem.
• Do not give this medicine to anyone younger than 18 years of age.
How should I take zolpidem?
• Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
• Zolpidem comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
• Take zolpidem only if you are able to get a full night's sleep before you must be active again. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.
• Take zolpidem with a full glass of water.
• Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice.
• You may have withdrawal symptoms if you stop taking zolpidem after taking it over several days in a row. Do not stop taking zolpidem suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.
• Withdrawal symptoms include behavior changes, stomach pain, muscle cramps, nausea, vomiting, sweating, anxiety, panic, tremors, and seizure (convulsions). Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
• Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.
• Store zolpidem at room temperature away from moisture and heat.
What happens if I miss a dose?
• Since zolpidem is usually taken as needed, you may not be on a dosing schedule. Never take this medication if you do not have a full 7 to 8 hours to sleep before being active again. Do not take extra medicine to make up a missed dose.
What happens if I overdose?
• Seek emergency medical attention if you think you have used too much of this medicine. An overdose of zolpidem can be fatal when it is taken together with other medications that can cause drowsiness.
• Symptoms of a zolpidem overdose may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
What should I avoid while taking zolpidem?
• Zolpidem can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
• Do not drink alcohol while you are taking zolpidem. It can increase some of the side effects of zolpidem, including drowsiness.
• Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).
• Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.
• Take zolpidem only if you are able to get a full night's sleep before you must be active again.
What are the possible side effects of zolpidem?
• Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
• Stop using zolpidem and call your doctor at once if you have any of these serious side effects:
· worsening sleep problems;
· depressed mood, thoughts of hurting yourself;
· unusual risk-taking behavior, decreased inhibitions, no fear of danger;
· aggression, feeling agitated;
· hallucinations, confusion, loss of personality.
• Continue taking zolpidem and talk to your doctor if you have any of these less serious side effects:
· daytime drowsiness;
· dizziness, weakness, feeling "drugged" or light-headed;
· weakness, lack of coordination;
· amnesia, forgetfulness;
· headache;
· vivid or abnormal dreams;
· diarrhea, nausea, vomiting;
· muscle pain; or
· blurred vision.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect zolpidem?
• Before taking zolpidem, tell your doctor if you are using any of the following drugs:
· itraconazole (Sporanox);
· rifampin (Rifadin, Rimactane, Rifater);
· antidepressants such as imipramine (Janimine, Tofranil), fluoxetine (Prozac, Sarafem), or sertraline (Zoloft); or
· narcotic pain medications, muscle relaxers, seizure medications, or anti-anxiety medications.
• If you are using any of these drugs, you may not be able to use zolpidem, or you may need dosage adjustments or special tests during treatment.
• There may be other drugs not listed that can affect zolpidem. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
• Your pharmacist has information about zolpidem written for health professionals that you may read.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/ or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 4.02. Revision date: 12/ 4/ 06.
My Conclusions
Symptoms can be severe enough to be diagnosed as a drug induced psychosis
Ambien operates on the neurotransmitter GABA and is a mild anticonvulsant as well as sedative. It requires an MINIMUM of 8 hrs to flush out of the Central Nervous system at the normal dose of 5 mg and can take longer if the patient is overdosing recreationally. A large dose is considered to be only 10 mg.
In short, don't drive if you haven't had at least 7-8 hrs of sleep because you are not going to be fully functional.
You can also experience what is in effect, operating in a blackout, in that you are functioning but asleep, experiencing the world as a vivid dream. This normally occurs during recreational abuse where the taker is fighting the effects of the drug to stay awake and occurs at fairly high doses. I am not really able to address any more of the issues as I actually need to do some more research on this myself to both confirm my data as well as see if there are any new behavioral/cognitive issues involved with Ambien and related compounds.
More info on Ambien and it's side effects and cross drug interactions is here:
http://en.wikipedia.org/wiki/Zolpidem
I normally wouldn't cite a Wikipedia site, but it is pretty accurate in this case and doesn't require a paid access like JSTORE or the Journal of the APA.
sbhikes
03-19-07, 08:37 AM
Every time they come out with another highly advertised drug, several months later out come stories like these. Thanks, but if any drug is advertised on TV, I don't want it.
East Hill
03-19-07, 09:09 AM
Every time they come out with another highly advertised drug, several months later out come stories like these. Thanks, but if any drug is advertised on TV, I don't want it.
So, if you were me, you would stop using Imitrex for migraine, which I've been using since 1993 :eek: ?
East Hill
chemcycle
03-19-07, 11:08 AM
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.
And that's just sleepwalking, which some people do on there own.
"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.
HHHMMMMMM......seems to be a connection here.
All the "data" people are posting doesn't seem to have any hard numbers. But they're willing to speculate that there MUST be most cases out there....1 in 100.......where does that number come from?
"I hate pharmaseuticals (and cars)" is not a useful data point.
Tom Stormcrowe
03-19-07, 11:19 AM
And that's just sleepwalking, which some people do on there own.
HHHMMMMMM......seems to be a connection here.
All the "data" people are posting doesn't seem to have any hard numbers. But they're willing to speculate that there MUST be most cases out there....1 in 100.......where does that number come from?
"I hate pharmaseuticals (and cars)" is not a useful data point.
Hopefully, I should have some "hard" numbers in a couple of days. When I have that data sourced and vetted for accuracy, I'll post it.:D
slowandsteady
03-19-07, 12:55 PM
Every time they come out with another highly advertised drug, several months later out come stories like these. Thanks, but if any drug is advertised on TV, I don't want it.
Because the lawyers know the pharma companies have deep pockets..... come on people don't get your scientific "data" off of the six o-clock news. They are just trying to sell advertising time. Sensationalistic stories whether they have merit or not boost their revenue.
lima_bean
03-19-07, 01:01 PM
How is this different than a full blown psychotic episode?
I think it's a mistake to assume that these people are just "sleeping". They're in some sort of consciousness where they have some sense of what is around them (walls, fridge doors, car keys) but at the same time experiencing hallucinations.
Damn scary if you ask me.
You can categorize it any way you want, but its something that happens when you are asleep, and you have no memory of it. Its generally referred to as Sleepwalking, with other nicknames like Sleepsex etc depending on what you actually do during it. Calling it a psychotic episode or sleepwalking or whatever, doesnt really matter =p
sbhikes
03-19-07, 01:58 PM
Just saying I don't want to be a guinea pig to pay for huge pharmasuetical marketing budgets.
Oh, but I am one, aren't I, since we all get to participate in the grand sleep-driving experiment.