Petition Closed
Petitioning The Food and Drug Administration
This petition will be delivered to:
The Food and Drug Administration

I want the FDA to take Ambien off the market.

This is important because Sanofi-Aventis (the maker of Ambien, who is raking in billions of dollars of revenue from the drug), will not voluntarily withdraw this drug from the market to evaluate new adverse reaction data, although many deaths, injuries, and arrests are directly related to the use of Ambien.


Letter to
The Food and Drug Administration
I just signed the following petition addressed to: The Food and Drug Administration.

The generic drug, zolpidem tartrate, sold as Ambien in the United States, has life-threatening and community-impacting adverse effects. The goal of this petition is to encourage the FDA to take it off the market, while evaluating increasing reports of suicide, violent crimes, and parasomnia (sleep-driving/cooking/eating/sex/communication/aggression), which have resulted in documented negative outcomes for patients, their families, and innocent parties.

The maker of Ambien, Sanofi-Aventis, has long been aware of these life-threatening drug reactions, but chose not to disclose it on the package insert or in their marketing to physicians. It took a class action lawsuit in 2006 to force them to inform consumers and physicians of the inherent danger associated with the use of Ambien (see http://www.appellate-brief.com/practice/federal-litigation/pharmaceutical.html). In their revised package insert, Sanofi-Aventis expose the following threat to patients taking Ambien:

"PRECAUTIONS AND WARNINGS: 5.3 Abnormal thinking and behavioral changes—a variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g. aggressiveness and extroversion that seemed out of character). . .Visual and auditory hallucinations have been reported as well as behavioral changes such as bizarre behavior, agitation and depersonalization. . .

Complex behaviors such as “sleep-driving” (i.e. driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. . .Due to the risk to the patient and the community, discontinuation of Ambien should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g. preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably."

Seriously, is this all right? Should a drug that causes sleep-driving, visual and auditory hallucinations, and unpredictable neuro-psychiatric symptoms be allowed on the market without, at the very least, a Black Box Warning to consumers and physicians? Should a pharmaceutical company be allowed to continue selling a drug that has shown an increasing pattern of serious side effects for thirteen years, which contradicts their initial clinical trial findings? Will a patient reading the package insert truly comprehend what “abnormal thinking and behavior changes” are without a point of reference or knowledge of psychiatry? The answers are NO, NO, and NO.

But, don't take my word for it. Do the research yourself. There are factual, credible accounts of people who have driven while asleep; crashed their cars; and, in some incidents, killed innocent bystanders. Others who have been jailed for DUI, although Ambien was the only drug in their bloodstream--just ask Kerry Kennedy. Some have accidentally overdosed on the drug (allegedly, Heath Ledger). In cases of suicides, Sanofi-Aventis relieves themselves of liability by saying that the product insert clearly states not to mix Ambien with alcohol or other drugs, especially anti-depressants. At the same time, however, they are aware that in a parasomnia state, patients taking Ambien will ingest all sorts of things, including additional Ambien, alcohol, other drugs, and bizarre things like microwaved paint, etc. They are also aware that physicians are prescribing anti-depressants and Ambien together as a regimen, although the package insert clearly warns against it. There are also people who are taking Ambien that have caught their houses on fire while sleep-cooking, and others who have performed sexual acts that, when awake, they would have found disgusting. Just search topics on the internet, such as Ambien + side effects, DUIs, accidental overdoses, suicides, murders, murder-suicides, violent crimes, etc. You’ll be shocked at what you’ll find. There are countless reports (dots) out there that aren’t being connected. That is why I feel a petition like this is necessary. It’s a way to create awareness, where people can connect the dots and demand that the FDA and pharmaceutical drug companies remain accountable for consumer safety.

So far, this petition has discussed shocking concerns for the general public.

However, there are other categories of serious side effects listed on the Ambien package insert from cardiovascular and gastrointestinal systems to liver and respiratory systems. Any of the multitudes of possible adverse reactions should be reason enough to pull this drug off the market. But, I'm most interested in sharing some specific alarming adverse side effects. From the product insert, it reads :

"ADVERSE EVENT INCIDENCE ACROSS THE ENTIRE PREAPPROVAL DATABASE. . .Central and peripheral nervous system: . . .Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion. . .paresthesia. . .speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy. . . delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts. . ."

Please sign this petition. We may not be able to get the FDA or Sanofi-Aventis to remove this drug from the market. But, we can spread awareness, so others stop taking it or never start taking it. By signing this petition you may be saving the life of a fellow human being. Thank you.

Sincerely,
Sherri Swanson Defesche