FDA Warns AMBIEN May Be Linked To Bizarre Behavior, Who Would Have Thought!?

Sleep medications like Ambien have long been controversial and have been linked to bizarre behavior in users.

On Tuesday, the Food and Drug Administration (FDA) announced that it is requiring manufacturers of Ambien and other sleep medications to add a Boxed Warning – the agency’s most prominent warning – to the prescribing information and the patient Medication Guides for these drugs.

Often referred to as a “black box warning”, the label is the strictest alert placed on prescription drugs or drug products by the FDA when there is reasonable evidence of an association of a serious hazard with the drug. As the name indicates, it is a warning with a black box around it. Having the black box around the warning means that an adverse reaction to the drug may lead to death or serious injury.

The agency is warning the public that rare but serious injuries and deaths have been linked to the use of certain common prescription insomnia drugs. Dangerous behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep, according to the FDA’s Safety Announcement.

Sleepwalking, sleep driving, and engaging in other activities while not fully awake (like using the stove) are among the risks associated with the medications, the agency explains:

We identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death. This number includes only reports submitted to FDA or those found in the medical literature, so there may be additional cases about which we are unaware.

These cases included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts. Patients usually did not remember these events. The underlying mechanisms by which these insomnia medicines cause complex sleep behaviors are not completely understood.

“The boxed warning and contraindication are intended to make the warning more prominent and reflect the risk of serious injury and death,” the FDA clarifies.


This seems like an unreasonable classification by the FDA based on the high rates of usage and low incident rates over a very long time time.

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Not really! There are probably a lot more cases being unreported and considering the state of our culture putting such warning labels on such products is a good move.

And when you consider the details of this case, then you can understand why the FDA is wanting to crack down!

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I can only say how grateful I am that the little packets in my new box of shoes tell me not to eat it. Also, plastic bags on new products shouldn’t be put over my head. Not to forget it is a crime to remove my mattress tags. :stuck_out_tongue_closed_eyes:

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I agree - maybe if they were seeing 66 cases a month…but a TOTAL of 66 cases in 26 years seems to be within an acceptable number. I am sure the families of the people impacted don’t feel that way…but all they are doing is putting a stupid label on a box. Nothing changes.

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Few read the warnings.

Look at the warnings on cigarettes yet people still use them.

What? when did that happen???

I purposely remove the tags and await the arrival of the mattress police. One day in the future when I have forgotten that I removed the tags they will arrive, inspect and arrest my daughter as I say she did it.


Wrong! This shit is nasty and causes untold suicides.

Prescribed WAY too often for marginal conditions.

Better off with medical pot…lots of it.


IDK. One day they weren’t there… Then the next they were. When it said I shouldn’t eat it all I could think about was how tasty they must be. :yum:

Ahh, I put a dab of peanut butter on it and let my dog chew on it. Take a pic and then tell the officer with a sympathetic shoulder shrug “What can I do? It ate my tax returns, too.” :lying_face:

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No Camp, it isn’t nasty. Cite the suicide rate directly correlated to a sleep aid.

People take sleep aids because they cannot sleep. Lack of sleep causes many more problems than sleep aids.

Not everyone responds to “medical pot”. Not everyone responds to medical sleep aids.

You’ve got 66 cases over 26 years? That has to be a record for safety compared to the side effects of other drugs on the market.

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LOl, cocaine would bar suit you.

Including todays high THC pot.

I would urge more caution and stand by my assertion that this drug is NASTY. It replaced a drug that was notorious for suicide.

Although the Ambien prescribing information warned, in small print, that medications in the hypnotic class had occasional side effects including sleep walking, “abnormal thinking,” and “strange behavior,” these behaviors were listed as extremely rare, and any anecdotal evidence of “sleep driving,” “sleep eating,” or “sleep shopping”—all behaviors now associated with Ambien blackouts—were characterized as unusual quirks, or attributed to mixing the medication with alcohol. It wasn’t until Patrick Kennedy’s 2006 middle-of-the-night car accident and subsequent explanation to arriving officers that he was running late for a vote that the bizarre side effects of Ambien began to receive national attention. Kennedy claimed that he had taken the sleep aid and had no recollection of the events that night.

Shortly after the Kennedy incident, Ambien users sued Sanofi because of bizarre sleep-eating behaviors while on the drugs. According to Susan Chana Lask, attorney for the class action suit, people were eating things like buttered cigarettes and eggs, complete with the shells, while under the influence of Ambien. Lask called people in this state “Ambien zombies.” As a result of the lawsuit, and of increasing reports coming in about “sleep driving,” the FDA ordered all hypnotics to issue stronger warnings on their labels.

In addition to giving consumers extra information so they could take the medication more carefully, the warning labels also gave legitimacy to the Ambien (or Zombie) defense.


66 cases over 26 years. Negligible.

People have a considerable amount of responsibility when taking medications. Read the side effects and be watchful and cognizant of any signs or symptoms. There are more than likely alternates which can be tried which are more compatible to the physiology of the individual.

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What? That means personal responsibility, unheard of today.

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