New warnings for sleeping pills

[Al-khiyal]

Drug linked to night driving, binge eating and hallucinations:

NEW YORK: The most widely prescribed sleeping pills can cause strange behavior like driving and eating while asleep, according to the U.S. Food and Drug Administration, which announced Wednesday that strong new warnings would 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 safely use them. 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 the sleeping pills have increased.

U.S. sales 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 in the United States since 2000, fueled by television, print and other advertising. Last year, makers of sleeping pills spent more than $600 million on consumer advertising.

The agency's review was prompted, in part, by queries to it 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 covered 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 it was not aware of any deaths caused by sleep driving. The reports gained credence from scientific studies. A forensic toxicologist in Wisconsin, Laura Liddicoat, gave a presentation at a meeting on six instances of Ambien-impaired driving.

Dr. Carlos Schenck and Dr. Mark Mahowald of the University of Minnesota said they had been studying cases of nearly 30 Ambien users who developed unusual nighttime eating disorders. In some cases, the patients had gained more than 100 pounds, or 45 kilograms.

In May 2006, in Washington, Representative Patrick Kennedy, Democrat of a Rhode Island, blamed Ambien when he crashed his car near the Capitol.

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 occurred after they took their pills and headed for bed.

An agency official said Wednesday that the activities associated with the drugs went beyond mere sleep walking.

"We do believe that sleepwalking is different from these behaviors," said Dr. Russell Katz, the agency's director of 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."

Katz said that it was not entirely clear whether people reporting the problems were technically asleep or awake. Although Katz characterized the side effects as "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, Katz said.

An Atlanta defense lawyer who specializes in impaired-driving cases, William 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," 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," 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 Katz, who said the drug makers must submit drafts by May. He said the drug makers had been working with the agency on the wording since it 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.

New warnings for sleeping pills

[Cheba_Mami]

try to avoid using sleeping pills as much as possible.

[Yazou]

what al-khyal is reporting here is real folks. It's gotten attention because of senator Kennedy who was accused of driving under influence and he told thee police that he tool sleeping pills (Ambien). Some people found themselves cooking dinner at 3AM and being totally asleep, others drove to work and not remembering a thing... these cases are rare, but enough to make you be more cautious and not depend on this poison to sall asleep.

[Bent_Bladi]

yeah... i always laugh at those sleeping pill commercials... what b.s....

[amalgamate]

no dear, they're the perfect remedy for sleep-deprived patients. It works wonders and people want to take it daily. although this pill, Ambien, is supposed to be for temporary relief of insomnia and only taken a max of 14 pills/month, folks pay cash for more of this drug. insurance co don't cover a month's supply of ambien and they warn against taking it for extended period of time. but hey, if you're paying cash- who cares what your insurance says right? "the doc prescribed 30 so i want 30!"


i knew it was only a mater of time before we see shocking side affects of taking this drug in exceding doseages the FDA had set. People have been taking ambien daily for months after months, years after years non stop.

if y'll can't fall asleep, make some chammomile tea and drink it at night! somehow everytime we drink that at night- every one of us falls asleep within 30 minutes.

weird