QUOTE(judy @ Mar 9 2006, 07:01 AM) [snapback]189980[/snapback]
Drivers Who Ought To Be In Bed
The lab that does forensic work for the state
of Wisconsin says it found the insomnia drug Ambien
in the blood of 53 drivers who police say exhibited
extreme cases of erratic behavior at the wheel.Are there really people out there who have been driving in their sleep? And then claimed they couldn't remember where they had been?
CBS News correspondent Trish Regan reports that is what some people are claiming after taking Ambien, the most popular insomnia medication in the U.S.
Over 26 million prescriptions were sold last year, ringing up more than $2 billion in sales for the French pharmaceutical giant Sanofi-Aventis, the third largest drug company in the world.
Regan reports new research indicates Ambien's popularity could be contributing to accidents on the roads.
Forensic toxicologist Laura Liddicoat – reporting on tests on blood samples of 2,300 impaired drivers in the state of Wisconsin - says that in 53 of the most extreme cases of erratic behavior at the wheel, the drivers had one thing in common: they all had Ambien in their blood.
They wouldn't have, she says, if they'd been taken the drug the way it is supposed to be used – for a full night's sleep.
"Ambien has a very short half life and a quick elimination period," Liddicoat explains. "If it's taken as directed, there will be no drug left in the blood after eight hours of sleep, or at least a very low amount of the drug, so therefore it really should not be seen in drivers."
The fact that it is turning up in the lab, says Liddicoat, shows that drivers are either "not taking it before going to bed, and/or they are taking large amounts of the drug. We certainly know that in one case, there were at least seven to ten pills taken... So that's certainly not one pill before bed, or, as instructed."
"The driving was so bizarre - such as driving on the opposite side of the road, having head-on collisions," says Liddicoat of the cases sent to her office for testing. "Simply bizarre behavior - it wasn't simply weaving in the lane."
Liddicoat, supervisor of the state of Wisconsin's lab for alcohol and drug tests in impaired driving and death investigations, says the drivers were disoriented and suffered from memory loss.
Sean Joyce, who says he took Ambien, tells CBS News that those symptoms are all too familiar.
"I woke up in a cell with no memory of what happened," says Joyce, talking about an incident last year when, on a flight to England, he suddenly tore off his shirt and threatened other passengers.
"I'd gone berserk on the plane, I couldn't breathe," says Joyce, whose defense is the claim that he was under the influence of Ambien.
In a written statement, Sanofi-Aventis told CBS News that while "rare adverse events of sleepwalking have been reported... When taken as prescribed, Ambien is a safe and effective treatment for insomnia."
In press releases last year and in 2004 discussing Ambien - whose chemical name is zolpidem tartrate – Sanofi-Aventis said it is "indicated for the short-term treatment of insomnia," and there is "a low occurrence of side effects" associated with short-term use.
In May 2004, the drug company also said a 12-week clinical trial found no evidence of patients developing a tolerance or needing a dose escalation, demonstrating that Ambien "may be beneficial with long-term, intermittent use."
The company warns new users of the drug to "use caution in the morning when engaging in activities requiring complete alertness until you know how you will react to this medication." Sanofi-Aventis also says "in most instances, memory problems can be avoided" if Ambien is taken only when a patient is able to set aside enough time for a full night's sleep – defined as seven to eight hours - before the patient needs to be active again.
Sanofi-Aventis also points out that the medication is non-narcotic, a non-benzodiazepine – a class of drugs commonly used in older sleep medications such as Halcion, ProSom and Restoril - and the "safety and efficacy of zolpidem," the drug's active ingredient, "has been reinforced by 17 years of real-world use."
The problem, one expert told CBS News, is that Ambien and other sleep aids have become the first choice for the treatment of even mild insomnia. He says patients are taking too high a dose for too long a time - and that can lead to serious side effects.
Another problem, reports Regan, is that a lot of people are not just taking Ambien – they are mixing it with other drugs, or they are taking alcohol – and when you combine all those things together, that's trouble.
Article Wow! Everyone is different. I have a friend who took Ambien for awhile (his sleep pattern was out of whack) and it was quite powerful. He would be out like a light shortly after taking it. I can imagine how one could be affected if they took more than one pill, or didn't get the full eight hours of sleep recommended (not many full time working people do get eight hrs. of sleep

).
One time, I took 2 Nighttime Tylenols at work during my break and immediately fell asleep. I never took that again. One never knows how even over the counter drugs can affect you - let alone a potent drug like Ambien.
*****
Other Good News/Bad News:
WASHINGTON -- A multiple sclerosis drug pulled from the market a year ago because of a rare but life-threatening side effect is on track to return - but with some strong restrictions on how it's used.
Advisers to the Food and Drug Administration unanimously recommended Wednesday that the government let Tysabri's manufacturers resume sales - but only to patients enrolled in a mandatory registry designed to track, if not minimize, the risk of a rare brain infection linked to the drug.
The FDA usually follows its advisers' recommendations, and agency drug chief Dr. Robert Temple signaled it would do so with Tysabri.
"Devastating diseases often are treated by drugs that have problems of their own," Temple noted.
But he cautioned that deciding to take Tysabri would be "a tough decision," because as many as one in every 1,000 users might get the brain infection called progressive multifocal leukoencephalopathy, or PML. Perhaps more troubling, there's no evidence that early detection of PML improves chances of survival.
"It may not kill you all the time, but it doesn't leave you in very good shape," Temple warned. "I think our major objective will be to explain as clearly as possible to people the nature of the risk and its severity."
The move delighted patients who had clamored for a second chance at Tysabri because, while not a cure, it does work differently than standard treatments for nerve-damaging multiple sclerosis.
"We have our hope back," said Christy Cooksey-Dressell, who told FDA's advisers how her mother, Janet Dressell, improved so much after a single Tysabri dose that she abandoned her walker - but now, 13 months later, is deteriorating badly again.
Only one other prescription drug, the irritable bowel treatment Lotronex, has ever returned to the market after being pulled because of dangerous side effects.
Tysabri's manufacturers voluntarily stopped sales last year, only four months after FDA initially approved the drug, because three users were diagnosed with PML. Two of them died.
Now, calling the risk remote and the drug's promise great, manufacturers Biogen Idec and Elan Corp. want to resume sales, and pledged Wednesday to work closely with the FDA on a risk-management program.
Multiple sclerosis afflicts about 350,000 Americans. The cause is unknown and there is no cure. The most common form causes periodic flare-ups of symptoms, which include trouble seeing and walking.
Recently published studies found that Tysabri cut the rate of relapse by as much as two-thirds, and reduced the number of people whose MS got worse. It appears to work by blocking destructive immune cells leaving the bloodstream and entering the brain, where they can inflame and damage nerves.
PML, the apparent side effect, is caused by a common virus that usually lies dormant. When it does cause disease, the most common victims are people with very weak immune systems, such as AIDS patients.
The question for would-be Tysabri users is how big a risk PML really poses. The one-in-1,000 risk that Temple cited could be higher, depending on the overall health of Tysabri users and how long they take the drug - or it might ultimately turn out to be lower.
Dr. Karl Kieburtz of the University of Rochester, who chaired the FDA advisory committee, cautioned that there are complicating factors: Clinical trials of Tysabri have included fairly young people whose MS wasn't too severe. And PML's symptoms are hard to distinguish from those of an MS relapse, because the two diseases both attack the coating of nerve cells.
All those unknowns helped push FDA's advisers to call for fairly stringent restrictions, Kieburtz said. In addition to a mandatory patient registry, the drug should be administered only in specially designated sites, such as infusion centers, trained in Tysabri's use - and only to patients with relapsing MS who take no other MS medicines.
http://seattlepi.nwsource.com/health/1500AP_MS_Drug.html