Yourlawyer.com (Ambien News)

Ambien, Lunesta, Other 'New-Generation' Sleep Aids Linked to Bizarre Behavior

Tue, 06 May 2008 00:00:00 -0400

New generation sleeping pills, like Lunesta and Ambien, may be as likely to cause serious adverse reactions as older sleep aids. While older pills are much more likely to cause daytime sedation, addiction and withdrawal symptoms, drug classified as nonbenzodiazepines (NBZs), including Lunesta and Ambien, seem just as likely to cause amnesia and erratic behavior.

Introduced in the 1990s, NBZs are all sedatives used for the treatment of insomnia. They have proved to be safer than both benzodiazepines and the older barbiturates, especially when taken in overdose, and also have less of a tendency to induce dependence and addiction although these issues can still become a problem with abuse of NBZs. As a result, NBZs like Lunesta an Ambien have become widely prescribed for the treatment of insomnia, particularly in elderly patients.

But it appears that NBZs have not eliminated all of the problems associated with sleeping pills. According to a report in The Wall Street Journal, an analysis of adverse-event reports filed with the World Health Organization suggests that some side effects of this generation of sleep medications may be as bad as- and even worse than - the older generation, including Halcion, which was banned in some countries.

The WHO Collaborating Center for International Drug Monitoring received 867 reports from 24 countries of people encountering amnesia, often coupled with confusion, agitation and other behavior disturbances, while taking the new sleeping pills, like Lunesta and Ambien, through March, 2007. That compares with 1,032 adverse reports with the older class of benzodiazepines, even though they have been on the market for decades longer.

People under the influence of these drugs have gone on eating binges, driven their cars and engaged in other activities that they later cannot remember. The Wall Street Journal relates one story of a woman who painted her front door in her sleep, and in some cases, people have had serious car accidents and even set fire to their homes while in the seemingly-hypnotic state sometimes caused by the drugs.

Such reports prompted the Food and Drug Administration (FDA) last year to require that Ambien, Lunesta and other similar drugs carry strong warnings. But these sleep aids are still wildly popular, and the number of prescriptions written for them grew by 10 percent last year.

Most sleep experts suggest that people experiencing insomnia avoid all drug remedies if possible, and try natural alternatives like avoiding caffeine, reducing stress and increasing exercise. Unfortunately, those measures don't always work, so anyone considering any type of sleeping pill, including Ambien and Lunesta, should be sure to take precautions.

It is a good idea to go to bed as soon as a sleeping pill is taken, as they can work in as little as 15 minutes. No one should ever take more than the maximum dose, and not type of sleeping pill should ever be taken with alcohol. Experts interviewed by The Wall Street Journal also suggested stashing car keys in an unusual place, and installing an alarm on the bedroom door for those who routinely use Ambien, Lunesta or other sleep aids.

Ambien Linked to 6 UK Fatalities, Possible Suspect in Heath Ledger Death

Mon, 28 Jan 2008 00:00:00 -0500

Ambien—trade name Zolpidem in the United States—has been linked to six deaths in the United Kingdom and a large number of adverse reactions. Ambien is the sleeping drug which actor Heath Ledger admitted taking just weeks prior to his death. Ledger was found dead by his housekeeper at his New York apartment last Tuesday, and Ambien was among the prescriptions drugs found in his apartment. Results of a postmortem examination last week on the actor were inconclusive and additional toxicology testing is being conducted; however, there has been growing speculation that Ledger died from an accidental overdose of sleeping pills.

In Britain, were it is marketed as Stilnoct, Ambien is suspected in six fatal suspected adverse drug reactions since 2002, according to the Medicines and Healthcare products Regulatory Agency (MHRA) since 2001. In addition to the deaths, there have been nearly 200 other incidents of adverse reactions, ranging from psychiatric and cardiac disorders to injuries and eye disorders reported to the MHRA since 2001.

Ledger’s death prompted actor Jack Nicholson to say that the tragedy could be a warning about the dangers of certain sleeping pills. Nicholson reported that he had taken Ambien and suffered serious side effects as a result, saying "I warn people about Ambien. I almost drove off a cliff once. I don't take sleeping pills but somebody said, ‘take this, it's mild'.” "I got a call in the middle of the night, kind of an emergency, and I almost drove off a cliff 50 yards from my house. I live up in the mountains in Aspen. It's something to warn people about," he said.

MHRA data indicate the incidents are recorded under its "yellow card" scheme, which doctors in the UK use to alert the MHRA to patients suffering side effects to a drug. Health professionals and patients report reactions on a voluntary basis while companies are legally bound to report. The reporting system was created to act as an early warning system to alert authorities to previously unrecognized problems.

In addition to the fatalities, a total of 197 suspected adverse drug reactions have been reported connection with Ambien. The majority of the cases were categorized as psychiatric disorders. The six cases of deaths linked to a suspected adverse reactions to the drug were also recorded and three of those involved psychiatric disorders; the remainder were categorized as general disorders, injuries, and vascular disorders.

Last year, research by Australia's Federal Health Department linked Zolpidem to a series of incidents of strange behavior, including a woman who painted her front door while still asleep. And problems have emerged in America, where some people were injured by cars driven by people under the influence of the drug.

A spokesman for the MHRA said the safety of Zolpidem has been carefully monitored and product information had been updated to include warnings of psychiatric adverse effects. A spokesman for Sanofi Aventis, which makes Stilnoct, said it could not comment on the MHRA figures, but said when taken as prescribed, the drug was "generally well tolerated."

Woman blames 'sleep driving' on Ambien

Fri, 16 Mar 2007 00:00:00 -0400

You've heard of sleep walking, "sleep eating," other bizarre behaviors associated with the medication Ambien.

On Wednesday, the FDA urged drug makers to add warnings about these side effects on their labels.

But for one North Texas woman, the caution comes too late.

She may be headed to jail because of what she did while she was sleeping.

"Earrings, diamonds, pendants," says Phyllis Graham, were all the result of what she calls an "Ambient night."

"I was on QVC and Ebay."

She has no recollection of buying any of it.

"I'm very embarrassed that any of this has happened to me."

And while compulsive sleep shopping might be embarrassing, it's not criminal.

But Graham could go to jail for something else she can't recall.

About two years ago, after taking her nightly dose of Ambien, she slipped out of bed and into the driver's seat of a truck.

"Last thing I remember, I was in Arlington jail."

What she can't remember before that, is driving down the block, crashing into this house, then wandering home.

"Then the next thing I hear is her knocking on the window and she's wanting in the house," says her husband Bobby Graham.

He says he was stunned when police showed up and arrested his wife for DWI.

The police report shows Phyllis Graham "intentionally or knowingly" drove the vehicle "while intoxicated."

She says that's not true.

"I did not know I did this. I was not aware of anything. I don't even drive my husband's truck to begin with."

A breathalyzer test Graham voluntarily took showed no alcohol.

She says Ambien caused her to crash into the house.

Arlington police confirm a urine test did show traces of Phenobarbital, a drug used in her reflux medication and Zolpidem - also known as Ambien - but no alcohol.

On Monday, Phyllis Graham goes to trial for driving while intoxicated.

And, she is pleading.

"Yes, I'm innocent, 100 percent innocent."

In the meantime, she latches her door at night.

There are now three latches on the door.

"I make sure there's no way I can get out."

Phyllis Graham hopes home is the only place she'll be locked up.

New labels on sleep aids to specify odd effects

Thu, 15 Mar 2007 00:00:00 -0400

Under pressure from the federal government, drugmakers are revising the labels on Ambien, Lunesta and other popular sleep aids to warn that the pills may result in users driving, eating and even having sex while sleeping, health officials said Wednesday.

The manufacturers of 13 popular medications, taken by millions of Americans, are preparing information bulletins for users that will highlight the possibility of bizarre nighttime side effects.

The Food and Drug Administration requested the action to discourage patients from taking higher-thanrecommended doses or combining use with alcohol consumption. Dr. Russell Katz, director of the agency’s neurology division, said it had received more than a dozen reports of strange behavior.

“We don’t think that these [side effects] are sufficiently frequent that it would cause us to re-evaluate whether or not the drugs should be on the market,” he said. “But we do believe the labeling needs to be changed.”

The side effects also may include trouble breathing and other severe allergic reactions, Katz said, but it’s the strange sleep-time behaviors that have prompted scientific study and attracted national attention.

Patients taking Ambien, in particular, have said they woke up to find themselves gorging on food. Some cooked while asleep. Others talked on the telephone while asleep or had sex. Some others learned afterward that although they had been behind the wheel of their car during the night, they had no recollection of driving.

Car accidents have been linked to its use, including one involving Rep. Patrick J. Kennedy, D-R.I., who later sought treatment for substance abuse.

“Two of our patients started fires in their kitchen, two drove automobiles — that’s serious,” said Dr. Carlos Schenck, a senior staff physician at the Minnesota Regional Sleep Disorders Center, who published a study on the strange side effects and is working on another.

Schenck emphasized that the incidents are rare. They have tended to occur in young and middle-age women taking other medications at the same time, and they followed from use of Ambien, not other sleep aids.

“With very few other exceptions, it’s the Ambien,” Schenck said. “So I question why the other” sleep aids are receiving warnings and medication guides.

Besides Ambien and Lunesta, the other medicines to receive warnings are: Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Placidyl, ProSom, Restoril, Rozerem, Seconal and Sonata.

Sleeping pills are widely used, with Ambien the most popular prescription sleep aid. Doctors wrote nearly 50 million prescriptions for sleep medications last year, generating $3.6 billion in sales, according to IMS Health, a health-care information company.

Some physicians complain the drugs are used too commonly. Patients should first try inducing sleep by avoiding alcohol late at night, eating earlier in the evening and avoiding overly exciting TV shows before bedtime, suggested Dr. Phil Buescher, who prescribes sleep aids to patients at Union Memorial Hospital in Baltimore.

Sleep specialists, however, emphasize the drugs’ safety and effectiveness.

“Just as likely for many people, it’s simply the amnesia that goes along with deep sleep or with taking these medications,” said Dr. David Neubauer, a sleep specialist who has worked as a paid consultant for several sleep-aid manufacturers. He also has served on an expert committee that advises the FDA about the drugs.

FDA wants pill labels to warn of `sleep-driving'

Thu, 15 Mar 2007 00:00:00 -0400

The U.S. Food and Drug Administration has told the manufacturers of 13 brands of sleeping pills, including Ambien, Lunesta and Rozerem, to change labels on the pills to warn consumers of possible adverse events such as severe allergic reactions, "sleep-driving" and preparing and eating food while asleep.

The FDA defined sleep driving as "driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event."

Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said Wednesday the agency first alerted manufacturers about the stronger labeling in December and has spent the past three months working with the drug companies on the wording, and preparing to notify doctors and consumers of the risks.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," Galson said. "However, after reviewing the available post-marketing adverse event information for these products, the FDA concluded that labeling changes are necessary."

Dr. Glenn Singer, director of the Sleep Disorders Center at Broward General Medical Center, said the FDA lumped together the older class of sleeping pills with the newer ones, such as Ambien and Lunesta, which seemed to have a safer profile.

"We knew the older drugs were more dangerous, especially in the elderly," Singer said. "We would see things like hip fractures because people would get up in the night and fall."

"The use of these medications is often done without people doing a good evaluation to get to the bottom of the problem," Singer said. "No death certificate is ever signed `insomnia,' and there are some very good behavioral techniques to try [before opting for sleeping pills]," he said.

"The use of these pills has soared over the past few years," said Neal Nay, manager of JFK Medical Center's Sleep Disorders Center in Atlantis. "What we propose instead is cognitive behavioral therapy. A study came out about a year ago that showed that if you stick to it for two to three weeks, it works, but it takes some self-discipline," Nay said.

The FDA also asked each product manufacturer to send letters to health care providers to notify them about the new warnings. The manufacturers will begin sending the letters this week.

The agency also asked the drug companies to create patient medication guides about proper use and the recommendation to avoid drinking alcohol or taking other central nervous system depressants while using the sleeping pills.

And, the FDA recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep driving and other complex behaviors occur in association with individual drug products.

The drugs on the list are: Ambien, Butisol sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal and Sonata.

FDA wants stronger warnings for sleep disorder drugs

Wed, 14 Mar 2007 00:00:00 -0400

All sleeping pills, including the blockbusters Ambien and Lunesta, may sometimes cause a bizarre but dangerous side effect, sleep-driving, the Food and Drug Administration warned Wednesday.

It's like sleepwalking but behind-the-wheel: driving while not fully awake after using a sleeping aid with no memory of doing so.

The FDA ordered the makers of 13 products to strengthen warnings on their labels about two rare but serious side effects:

Sleep-driving, along with other less dangerous "complex sleep-related behaviors'' like making phone calls or fixing and eating food while still asleep.
And life-threatening allergic reactions, as well as severe facial swelling, both of which can occur the first time the pills are taken.

FDA told manufacturers to write letters to doctors to notify them of the new warnings, and all prescription sleeping pills now will come with special brochures called "Medication Guides'' that spell out the risks for patients in easy-to-understand language.

FDA wouldn't say exactly how many cases of sleep-driving it uncovered, or if it knew of any car crashes, saying only that "there have been rare adverse events reported.''

"Due to the potential for embarrassment and/or legal exposure, people are less likely to report some of the more complex sleep behaviors. Therefore, FDA is concerned that there may be extensive under-reporting of these events,'' said FDA spokeswoman Kimberly Rawlings. "It was important to alert people about the risk of complex sleep behaviors, especially sleep-driving because of the potential for this activity to cause harm or death to both the patients and the community.''

This entire class of medicine, known as sedative-hypnotic products, has these rare risks, FDA said. But some drugs may cause the problems more than others, so FDA recommended that manufacturers conduct clinical trials to figure that out.

The drugs are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.

FDA Requests Label Change for All Sleep Disorder Drug Products

Wed, 14 Mar 2007 00:00:00 -0400

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

FDA says pills can cause 'sleep-driving'

Wed, 14 Mar 2007 00:00:00 -0400

All prescription sleeping pills may sometimes cause sleep-driving, federal health officials warned Wednesday, almost a year after the bizarre side effect first made headlines when Rep. Patrick Kennedy crashed his car after taking Ambien.

It's a more complicated version of sleepwalking, but behind the wheel: getting up in the middle of the night and going for a drive with no memory of doing so.

The Food and Drug Administration wouldn't say exactly how many cases of sleep-driving it had linked to insomnia drugs, but neurology chief Dr. Russell Katz said the agency uncovered more than a dozen reports and is worried that more are going uncounted.

Given the millions of prescriptions for insomnia drugs, Katz called the problem rare, and said he was unaware of any deaths. But because sleep-driving is so dangerous and there are precautions that patients can take the FDA ordered a series of strict new steps Wednesday.

First, the makers of 13 sleep drugs must put warnings on their labels about two rare but serious side effects:

Sleep-driving, along with other less dangerous "complex sleep-related behaviors" like making phone calls, fixing and eating food, and having sex while still asleep.
And life-threatening allergic reactions, as well as severe facial swelling, both of which can occur either the first time the pills are taken or anytime thereafter.

Next, doctors this week will begin getting letters notifying them of the new warnings.

Later this year, all prescription sleeping pills will begin coming with special brochures called "Medication Guides" that spell out the risks for patients in easy-to-understand language.

Sleep-driving made headlines last May when Kennedy, D-R.I., crashed his car into a security barrier outside the U.S. Capitol after taking Ambien and a second drug, Phenergan, an anti-nausea pill that also acts as a sedative. Kennedy has said he had no memory of the event. He pleaded guilty to driving under the influence of prescription drugs, and was sentenced to court-ordered drug treatment and a year's probation.

Ambien isn't the only insomnia drug that can cause sleep-driving any of the class known as "sedative-hypnotics" can, FDA's Katz stressed Wednesday.

To lower the risk of a sleep-driving episode, he advised patients to never take any prescription insomnia drug along with alcohol or any other sedating drug. Also, don't take higher-than-recommended doses of the pills.

"We really want people to know these things can occur, and these sleep behaviors can be perhaps to a large extent mitigated by behaviors the patients can control," he said.

Some of the insomnia drugs may be riskier than others, so FDA also recommended that manufacturers conduct clinical trials to figure that out.

The drugs are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.

Fewer than one in 1,000 patients in studies of Ambien reported somnambulism a scientific term that includes the sleep behaviors flagged by the FDA said Lisa Kennedy, a spokeswoman for manufacturer Sanofi-Aventis SA, who is not related to the congressman. The side effect has remained similarly rare since widespread sales began, she said.

FDA Wants Tougher Labels on Popular Sleep Drugs

Wed, 14 Mar 2007 00:00:00 -0400

The Food and Drug Administration says all prescription insomnia drugs should have tougher labels that warn users they could have severe allergic reactions or unknowingly attempt potentially dangerous activities, such as trying to drive while still asleep.

In addition to strengthening the labels of their products, makers of sedative-hypnotic drugs need to send notices to health care providers and prepare medication guides for patients, the agency says.

The FDA's action, announced Wednesday, covers 13 drugs, most notably Ambien and Ambien CR from Sanofi-Aventis, Lunesta from Sepracor, Rozerem from Takeda and Sonata from King Pharmaceuticals.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

Some people taking the drugs have been known to drive, make phone calls or eat while they were effectively asleep or not fully awake. People experiencing these side effects generally have no memory of what they did.

The FDA sent letters to drugmakers in December telling them to revise their products' labels. The agency said the companies are sending warning letters to doctors and other health care professionals this week.

Although all sedative-hypnotic drugs can cause behavioral side effects, "there may be differences among products in how often they occur," the FDA says. The agency has asked companies to conduct clinical tests "to investigate the frequency with which sleep-driving and other complex behaviors occur" due to their products.

FDA Demands Stronger Warnings for Sleep Meds

Wed, 14 Mar 2007 00:00:00 -0400

LEMON: Well, the government wants new warning labels on a type of sleeping pill you've probably seen a lot of ads for or even use yourself. The drugs have been linked to sleep walking and even sleep driving in some cases. Our medical correspondent, Judy Fortin, is with us now, and she's going to tell us all about this. Wow.

JUDY FORTIN, CNN CORRESPONDENT: Yes, Don. We want to be clear. We're talking about prescription sedatives, and the Food and Drug Administration today is asking manufacturers of these prescription sleep disorder medications to strengthen the label information about potential risks.

And here's what we're talking about: risks like severe allergic reactions, severe facial swelling, and something that the FDA is calling complex sleep-related behaviors. You probably heard about these, like sleep driving, making phone calls, and preparing and eating food while asleep with apparently no memory of the events afterwards, something very frightening for people.

LEMON: I imagine that would be frightening. Obviously, there's a warning going out, a number of cases. How many cases are we talking about?

FORTIN: Well, the FDA won't say exactly. And that's the big problem. They say there have been rare but adverse events reported. And the agency is concerned about underreporting, people who don't want to admit or may be embarrassed by the fact that these things have happened. People who may be sleep eating, going into their kitchen and making full meals and then not wanting to tell people about it afterwards.

LEMON: All right. Let's talk about which drugs. Which drugs are targeted for this new labeling?

FORTIN: Well, there's specifically 13 prescription medications affected. For the full list, we want to tell people they can go to CNN.com or CNN.com/health. But I'll name a couple of them for you right now. We're talking about Ambien, Lunesta, Halcion and Rozerem.

The FDA has also requested manufacturers send letters to doctors notifying them of the new warnings. And companies must also develop something called a patient medication guide that will be distributed with the prescriptions.

LEMON: All those you mentioned are very popular drugs.

FORTIN: Sure.

LEMON: We see those ads for them all the time.

FORTIN: They're blockbusters.

LEMON: OK. So is this most drugs have warnings anyway. Is this going to go beyond the typical instructions handed out?

FORTIN: Well, presumably they will. You usually get some sort of a guide to your prescription medication anyway.

LEMON: Right.

FORTIN: The FDA is asking the manufacturers to go one step further. They're saying make this easy to understand, simple language. Make sure that the people understand the risks that are associated with the drugs.

We talked about driving under the influence of some of these drugs. That would be something like that. Making sure that you're not drinking alcohol or using central nervous system depressants at the same time. This is actual video of an example of someone who was under the influence of one of these sedatives and was caught on camera by police.

Now the FDA is asking that the guides be given not just to patients and I think this is interesting, Don. But they also want family members and care givers to get these guides so they can recognize some of this unusual behavior and make sure precautions are taken.

LEMON: That's amazing. Can we get that video back up? Because it looks like this person had been it looks like a sobriety test.

FORTIN: It does. Like they're weaving. And very often they don't remember these types of incidents.

So we want to mention one more thing, too. That not all of these drugs carry the same risks.

LEMON: OK.

FORTIN: And that's something the FDA wants drug manufacturers to look into. They want them to go back and do actual clinical trials. That's something that's actually done before these drugs are ever distributed to the public.

But they want them to do it again and make sure that, if there are any of these problems, with the sleep driving, the sleep eating, of course the more serious medical problems with the allergies, the allergic reaction and the facial swelling, that they know what risks are associated with these individual products.

LEMON: And Judy, thank you for this, because this is so important. A lot of people take these. I've even taken sleeping pills.

FDA Issues Warning About Sleep Medication

Wed, 14 Mar 2007 00:00:00 -0400

The U.S. Food and Drug Administration (FDA) has warned consumers about the risk of serious side effects connected with a range of sleep-disorder drugs and has asked drug manufacturers to strengthen their products’ label warnings. The new warnings highlight the risk of severe allergic reactions and erratic and dangerous sleep-related behavior.

The agency warned that anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling) can occur as soon as the first dose is taken. They also point to “complex sleep-related behaviors, which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).” They define “sleep-driving” as “driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.”

“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks.”

Among the 13 products in the affected class of drugs are Sanofi’s Ambien, Sepracor’s Lunesta, and Lilly’s Seconal. The FDA also recommended that “the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.”

Evidence of abnormal sleep-related behavior has been mounting in recent months. A year ago, the New York Times ran a series of articles describing abnormal sleep-related behavior in patients taking Ambien. A study by researchers at the Minnesota Regional Sleep Disorders Center discovered that a sleep-related eating disorder (basically, binge eating while sleeping) was a side effect of growing concern among Ambien users. The Times also reported on the sleep-driving phenomenon among Ambien users last March.

The other 10 sedative-hypnotics in question are: Butisol Sodium (Medpointe Pharm HLC), Carbrital (Parke-Davis), Dalmane (Valeant Pharm), Doral (Questcor Pharms), Halcion (Pharmacia & Upjohn), Placidyl (Abbott), Prosom (Abbott), Restoril (Tyco Healthcare), Rozerem (Takeda), and Sonata (King Pharmaceuticals).

Sleep drug dream for most, but a nightmare for others

Sun, 21 May 2006 00:00:00 -0400

As the media continues to report instances of patients sleepwalking, sleepeating and even sleepdriving while taking the prescription insomnia drug Ambien, online message boards continue to fill up with postings from patients who have had both good and bad experiences using the medication.

"It's 'good' to hear that others have had this sleepwalking response to Ambien. I don't remember doing anything, but I found the freezer emptied on the counter one morning, and, on another, my daughter woke to pizza burning in the oven. But the night she caught me moving furniture was the end. I just thought, 'What if I decided to drive?' and (I) haven't used it since," wrote a woman named Sidney last month on topix.net.

A few days later, a woman named Karen shared how much she has been helped by the drug.

"I have been taking Ambien for seven years and have had only MINOR side affects. This drug has given me my life back. I'm a chronic insomniac and went on four hours of sleep a night for years until I was properly medicated with Ambien. I feel GREAT now!!!!!"

In March though, a federal class action lawsuit was filed in New York on behalf of any patient who has taken the medication and experienced sleepwalking, sleepeating and/or memory loss.

Top seller

According to medical experts, Ambien is the most popular insomnia drug used by patients in search of a good night's rest.

"This is the most commonly prescribed hypnotic or sleeping aid in the United States," said Dr. Timothy McGee, medical director of the Edward Sleep Center and diplomat of the American Board of Sleep Medicine.

Ambien and zolpiderm, its active ingredient, have been used by millions of people in the U.S. and has provided 14 billion nights of patient therapy worldwide, said Emmy Tsui, spokeswoman in the company's New York office.

"It's one of our fastest-moving drugs and it's definitely within the top-200 drugs most used you could probably almost say that nationwide," said Karen Davis, pharmacist at Oswald's Pharmacy in Naperville. A one-month supply of the medication costs about $125 if a person were to pay cash, she said, and soon the generic form of the drug will be made available to patients.

The side effects

While behavior that ranges from simply bizarre to outright dangerous has been highlighted in print and broadcast media, local experts say they have not encountered anything as extreme as the examples in the news.

"I've heard of a couple of cases, but it's not a common complaint at all," McGee said. "I personally have not had any patients that have come back with bizarre stories."

He has had some primary care physicians call him to ask about their patients behavior while on the medication though, he said.

"These side effects are not common, but they are recognized," McGee said. "They've been recognized for a long time."

In response to reports of side effects, though, Sanofi-Aventis posted a statement on its Web site regarding the appropriate use of the medication:

"Recent anecdotal reports in the media have focused on rare occurrences of sleepwalking and sleep-related eating in patients who may also be taking Ambien. The safety profile of Ambien is well established and reported in the Ambien Prescribing Information approved by the U.S. Food and Drug Administration," the company said.

Medical experts stress that patients should follow the instructions given with the medication, including taking it just before bedtime.

"You have to be going to bed because it has a relatively quick onset of action and relatively short duration of action," McGee said. "It can hit you within 20 minutes."

Snooze Alarm: The Pill That Drove Us to Sleep

Sat, 06 May 2006 00:00:00 -0400

Zolpidem tartrate, the sedative-hypnotic better known to wide-awake, stressed-out sheet kickers as Ambien, is an efficacious little helper if you ever thought you might go crazy from not sleeping. It's "Goodnight Moon" for grown-ups. You should take it only with some Charlie Rose. Now it's also become the new explanation for that which goes bump in the night: I took an Ambien, Americans are saying, and then I don't know exactly what happened.

In explaining his Ford Mustang's woozy middle-of-the-night encounter Thursday with a Capitol security barrier, Rep. Patrick Kennedy (D-R.I.) joined a growing list of people who have partly or entirely blamed the popular sleeping pill for things that have happened out of bed. At a news conference yesterday, he said he was going back to rehab to again seek help for addiction to painkillers. He said he doesn't remember what happened at all, and again mentioned "medications" that he had taken. In addition to Ambien, Kennedy, 38, said that he had taken Phenergan for stomach and intestinal problems.

Once again, the national medicine cabinet practically begs to be snooped through. Setting aside for the moment his addiction problems, Kennedy doesn't seem all that different from a lot of almost-40 Washington wonks and wonkettes you might know. You ask them, "What's really wrong?" and they say it's nothing, getting up, flicking on the bathroom light. It's his stomach, it's his head, it's the committee meeting tomorrow. You hear the rattling of pills in a plastic bottle, the faucet running, then it's nighty-night, or something close to it.

Commercials for an Ambien competitor, Lunesta, offer the curled-up solace of the magic green moth; another commercial has sleepless wretches lassoing the moon. Ambien, in proper dosage, is one thing. It won't send you to the Mayo Clinic, and it sure beats snarling at your co-workers the next day. But many people do ignore its warnings and take it with, say, a nice glass of Bordeaux. Then they call you and start talking; it makes them entirely too truthy. ("What was that about?" you ask them a day or two later. "What was what about?" they say, and then remember: "Oh, Ambien." Say no more.)

Before Ambien became popular more than a decade ago, Type-A people who didn't want to take up residence in the Valley of the Dolls had to mostly make do with over-the-counter sleep aids: Unisom and its ilk packed a slow-acting wallop, requiring a pot of coffee to undo the morning-after effects. Entertainment mogul David Geffen used to swear by Tylenol PM.

What Ambien blessedly did was knock you straight into lights-out within 20 minutes or so, before you could even finish reading a "Talk of the Town" short in the New Yorker. You'd wake almost exactly eight hours later, completely dreamless, magazine subscription cards plastered to your chest, and feeling fine, feeling very Snow White on a spring day.

After all these beautiful nights together, according to recent news reports, the Ambien zombies are arising against their will to gorge themselves at the fridge, or take the wheel, or do something illegal.

It wasn't me, officer; it was Ambien. Cops in Washington state tell the New York Times that an increasing number of middle-of-the-night car crashes are connected to the drug. An unnamed nurse in Denver was pulled over, in her nightie, and promptly urinated on the street; she had taken an Ambien before going to bed and claimed not to know how she got there or who drank the half-bottle of wine on her counter. Sean Joyce, a British man on a flight from Charlotte to London, was arrested last year because he belligerently ripped off his shirt and threatened suicide, the Times reported. Joyce received a reduced, five-day sentence because he'd had an Ambien and a couple of those airplane bottles of wine; he remembered none of it. Watchdog groups say the drug is overprescribed and too easy to get.

We are lagged-out, pajama-wearing drifters lost in the gap between slumber and wakey-wakey, even though Ambien's manufacturer, Sanofi-Aventis, implores users to follow the directions, as always: Take the drug only when you're on your way to (or already in) bed, and only when you have seven or eight uninterrupted hours to devote to sleep; don't take it with booze; make sure your doctor knows if you're taking anything else. Which is good advice, but is often met with "blah blah blah."

There are no rock songs about Ambien, and if there were, they would be really slow. (There could be poetry about it, perhaps, but who'd be awake to read it?) People won't share their Vicodin, but they'll let you have half an Ambien. People seem to take it not for a week to 10 days, as recommended, but for years on end. And let's not say much about sex and Ambien, since there isn't much sex and Ambien: I'll just lay here, you do your thing, and Zzzzzzzzzzzzz.

In March, after Ambien was mentioned as a possible cause of several sleepwalking (or sleepdriving) incidents and perhaps girding itself for the inevitable lawsuits from users who wound up becoming creatures of the night under its influence Sanofi-Aventis issued a firm statement:

"Recent anecdotal reports in the media have focused on rare occurrences of sleepwalking and sleep-related eating in patients who may also be taking Ambien. The safety profile of Ambien is well established and reported in the prescribing information approved by the U.S. Food and Drug Administration. After recently conducting a thorough analysis, Sanofi-Aventis has not observed any significant change in that safety profile. The information currently contained in the U.S. prescribing information remains accurate: somnambulism is a possible rare adverse event."

Go on, read the entire statement, everything about Ambien, dear Ambien. Sweet, inculpable Ambien. As indications and cautions and data scroll by, your lids get heavy, and the longer it goes on, the less you remember. We got almost 27 million prescriptions for the stuff last year. That explains a lot, and why Americans cannot be completely blamed for what happened. For any of it, whatever it was.

Midnight munchies linked to sleeping pills

Wed, 15 Mar 2006 00:00:00 -0500

Strange behavior by insomniacs taking prescription drugs, ranging from binge eating to having sex while asleep, have raised safety questions about anti-insomnia medications such as Sanofi-Aventis’ Ambien.

Researchers in Minnesota are studying cases where insomniacs taking Ambien got up in the middle of the night, binged uncontrollably, then remembered nothing of their actions. The researchers expect to publish data shortly.

Such sleep-induced side effects while on the medications have been around for years, but the incidence is rising because of an explosion in the drugs’ use, specialists said.

Researchers haven't found a cause for the sleep-related eating disorder, although patients with a prior history of sleep-walking and women may be at higher risk, Dr. Michael Cramer Vornemann, lead researcher at the University of Minnesota Medical School and the Hennepin County Medical Center in Minneapolis, told the "Today" show Wednesday.

"Doctors who prescribe this medication do need to engage in discussions with patients to describe and try to understand potential contributors to this behavior," Vornemann told "Today."

The researchers identified 32 Ambien users who were experiencing sleep-related eating disorders with amnesia, part of a group of studies they plan to publish, according to a report in The New York Times Tuesday. The Minnesota researchers estimated that thousands of Ambien users in the U.S. experience sleep-related eating disorders while taking the drug.

Earlier research at the Mayo Clinic found similar results, that something in Ambien causes binge eating in susceptible people, according to the newspaper.

In the Minnesota study, patients who took other, older sleep medications didn't experience the disorder, Vornemann told "Today." "This is a particular association with Ambien," he said. "However, there are newer medications similar to Ambien that have come to market and we have yet to determine that prevalence."

About 30 million people in the United States take sleep medications, according to the American Academy of Sleep Medicine. By some counts that is a 50 percent jump since the beginning of the decade. Ambien boasts 12 billion nights of patient use. Other insomnia medications are Lunesta from Sepracor Inc. and Sonata made by King Pharmaceuticals Inc.

Some of the most serious side effects are short-term memory loss, and accidents involving patients who drive the next day while still feeling drugged.

“Patients who may have engaged in this unusual behavior at night it’s relatively rare and bizarre,” said Donna Arand, president of the American Insomnia Association.

“The daytime sleepiness that drugged feeling that people may have is probably the most worrisome because of the (vehicular) accidents that can occur.”

Increased use of the drugs is spurred in part by heavy advertising and patients may be using the drugs for longer periods than they are intended, experts said.

Memory problems
Consumer group Public Citizen warned that Ambien should only be used on a limited basis because it causes temporary amnesia, according to pharmacist Larry Sasich.

Because the Food and Drug Administration’s reporting system is voluntary and anecdotal, “we don’t know how big a problem it is we have no way to accurately to assess the prevalence,” said Sasich a consultant for Public Citizen.

Sanofi-Aventis said sleepwalking is a rare side effect listed on Ambien’s label and that it reports all events to the FDA. Still, it had no statistics about the prevalence of sleepwalking.

Ken Sassower, a staff neurologist at Massachusetts General Hospital in Boston said a colleague who had taken one of the sleep drugs could not recall advising residents on rounds the next morning.

“The memory issue may be an infrequent side effect, but when it occurs it can be pretty significant ... certainly that needs to be looked at in a more rigorous way,” he said.

Doctors recommended against abruptly stopping the drugs, which can cause withdrawal symptoms including seizures.

“The risk was always there; we are seeing it more now because so many more people are using the drugs,” said Merrill Mitler, program director at the sleep disorder unit at the National Institutes of Health.

Two women who claimed they became sleep-eaters while taking Ambien were among four former Ambien users who filed suit against Sanofi-Aventis in United States District Court in Manhattan last week, charging they were harmed by the drug, The New York Times reported.

Ambien linked to overnight food binging

Tue, 14 Mar 2006 00:00:00 -0500

U.S. studies have shown the popular sleeping pill Ambien triggers overnight sleepwalking and binge-eating without being aware of it among some users.

"These people are hell-bent to eat," said Dr. Mark Mahowald, director of the Minnesota Regional Sleep Disorders Center in Minneapolis, which is researching the odd side effect.

User Brenda Pobre, 54, of Salinas, Calif., said she would awaken to find candy wrappers next to her bed and Popsicle sticks on the floor near the refrigerator. She did not link Ambien to her nocturnal eating until after she gained 100 pounds, The New York Times said.

Her case is one being studied by the Mayo Clinic in Rochester, Minn.

Ambien, the U.S. brand name for the drug zolpidem, is sold in some countries under the brand names Stilnox and Stilnocht. It is by far the biggest U.S. seller with $2.2 billion in annual sales among a group of similar prescription sleeping drugs such as Lunesta and Sonata.

Sanofi-Aventis, the French company that makes the drug, has defended its safety in 13 years of use in the United States, and said all cases of sleep-eating have been reported to the Food and Drug Administration.

'Ambien' Sleepwalking: A New Phenomenon Linked to Overdoses of Zolbidem

Sat, 11 Mar 2006 00:00:00 -0500

News reports began to surface last week concerning a rather bizarre phenomenon referred to as “Ambien sleepwalking” in which people find themselves in a virtual “Twilight Zone” caused by overdoses of the sleep medication Ambien (zolbidem).

Although the data came from a small case study of the unusual effects of the drug on six drivers, it has caused quite a stir among healthcare professionals and people who use the drug to help them sleep.

Laura Liddicoat, supervisor of the toxicology section of the Wisconsin State Laboratory of Hygiene in Madison, presented her findings at the American Academy of Forensic Sciences meeting.

According to Liddicoat, drivers under the influence of unusually high doses of Ambien have crashed their cars and then had absolutely no memory of the accident. The sleeping pill apparently continued to impair drivers even after they have attempted to sleep off the effects.

The pattern involves taking the drug and not sleeping, or taking more than the recommended dose. Some drivers, for example, got up and drove in the middle of the night, while others, who planned to go to sleep as soon as they got home, took the drug before driving.

It appears that in these situations, the patients haven't slept all of the drug out of their system and some had also taken Ambien along with other antidepressants. Alcohol was not involved in any of the six cases reviewed.

According to Liddicoat, a standard 10 mg dose of Ambien produces serum levels of 121 ng/mL (58 ng/mL to 272 ng/mL). After eight hours of sleep, that level should be close to zero. In the six reported cases, however, levels were as high as 1,000 ng/mL, and in one case 4,400 ng/mL.

The results of having high amounts of the sleeping pill in their bodies have produced a variety of strange effects on drivers, including: driving on the wrong side of the road; crashing into stationary objects; and suffering confusion, imbalance, and memory loss. Some patients had no idea why they were in the hospital or were being arrested.

Liddicoat described extreme mental and physical effects when driving within five hours of taking the drug. "Drugged driving cases have been steadily increasing over the last five years, and Ambien cases have mirrored this trend, reaching a peak of 45 cases a year in Wisconsin alone in 2003 and 2004."

Tests on subjects the morning after taking a single dose 10 mg (5 mg in the elderly) right before bedtime revealed no significant residual effects on memory or actual driving. In large doses, and without ample sleep, however, Ambien patients displayed confusion or loss of memory.

Sanofi Aventis, the makers of Ambien, instructs patients to take the drug right before going to bed and only when they can devote a full eight hours to sleep. The company also cautions against operating heavy machinery or driving.
According to the New York Times, Sanofi Aventis maintains that "the drug's record after 13 years of use in this country shows it is safe when taken as directed." The company has provided the FDA with reports of people driving while sleep walking due to residual effects of the drug.

The six examples of impaired drivers Liddicoat presented are: (1) Driver taking 670 ng/mL while driving, reported to be "very out of it;" (2) Driver taking 500 ng/mL plus Celexa (citalopram) crashed into a parked car, bizarre behavior, couldn't follow simple instructions; (3) Driver taking 820 ng/nL, poor comprehension, nearly fell over; (4) Driver taking 190 ng/mL plus other antidepressants driving southbound in northbound lane; (5) Driver taking 1,000 ng/mL plus Zoloft (sertraline) crashed into a truck; got drug online and continued to increase doses; (6) Driver taking 4,400 ng/mL drove on rim of flat tire, hit mailboxes, very confused.

Ambien Side Effects, Sleep Driving Lawsuits | Sleepwalking, Memory Loss/Amnesia | Sedative-Hypnotic Medication

Sat, 11 Mar 2006 00:00:00 -0500

Ambien Side Effects May Be Linked to Sleep Driving Lawsuits

Ambien | Lawsuits, Lawyers | Side Effects: Severe Allergic Reactions, Complex Sleep-related Behaviors, Sleep Driving

On March 14, 2007, the U.S. Food and Drug Administration (FDA) demanded that Sanofi Aventis, the manufacturer of Ambien, a sedative-hypnotic drug toughen its product labeling to include harder language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

Along with the labeling revisions, the FDA requested that Sanofi Aventis send letters to health care providers to notify them about the new warnings. Other sedative-hypnotic medications that are the focus of the revised labeling include:

Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

Concerns have been raised about the safety of Ambien (zolpidem tartrate), the anti-insomnia drug manufactured by Sanofi-Aventis. Reports are surfacing people taking Ambien are experiencing sleepwalking, memory loss / amnesia, binge eating while sleeping, having sex while sleeping, and other disturbing side effects. Some of the most serious side effects involve Ambien users having auto accidents the day after taking Ambien due to daytime sleepiness and the lingering feeling of being drugged. One disturbing report concerned a physician at Massachusetts General Hospital in Boston who could not recall advising residents on rounds the morning after taking Ambien.

Ambien Studies Researchers in Minnesota are looking at instances where people taking Ambien for insomnia got up in the middle of the night and engaged in such behaviors as binge eating. The patients reportedly remembered nothing of the experience upon awakening. Dr. Michael Cramer Vornemann, a researcher at the University of Minnesota Medical School and the Hennepin County Medical Center in Minneapolis, said it appears that those with a prior history of sleep walking and also women may be at higher risk for experiencing these side effects. The researchers believe that thousands of people taking Ambien experience sleep related eating disorders. The researchers looked at older sleep aids and found that these side effects are unique to Ambien, and possibly other newer medications such as Lunesta and Sonata. Mayo Clinic research conducted earlier on Ambien had similar findings. Consumer group Public Citizen has called for very limited use of Ambien because it causes temporary amnesia.

Sleep Medication Usage According to the American Academy of Sleep Medicine, an estimated 30 million people in the U.S. take sleep medications, which represents a huge increase in recent years. The increase is partly due to manufacturers of anti-insomnia drugs investing heavily in consumer advertising. Sleep-induced side effects may be rising because of the increasing use of Ambien and other anti-insomnia medications.

Legal Help for Ambien Side Effects Victims

If you or a loved one took Ambien and suffered memory loss, sleep walking, or other harmful side effects, contact us for a free case evaluation about your case today. Please fill out the short form at the right, or call our lawyers at 1-800-LAW-INFO (1-800-529-4636).