Filed under: Etc., First Drive
FDA confirms sleep-driving phenomena
We first brought you news of "sleep-driving" earlier this month with bizarre tales of Ambien-takers getting behind the wheel at all hours, driving and remembering none of it. A defense lawyer at that time blamed it on users of the sleep drug mixing it with alcohol or taking higher than recommended doses.Well, the FDA is stepping into the argument with demands that makers of 13 sleep aid drugs include labels warning users of side effects including sleep-driving, making phone calls while asleep and preparing food while asleep. And, we presume, possibly all three at the same time. Though seeing someone driving erratically while talking on their mobile phone and using the other hand (the left one, of course) to turn the burgers on the passenger-seat grill wouldn't surprise us. At all.
Check out the jump for the FDA's press release and see if your sleep-aid drug is one to get the new warning label.
[Source: The Associated Press via CNN.com]
FDA Requests Label Change for All Sleep Disorder Drug Products
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)
For more information on the sedative hypnotic products and sleep disorders, visit http://www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm;
www.fda.gov/womens/getthefacts/sleep.html and www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html.
Reader Comments (Page 1 of 1)
TTW 9:42PM (3/14/2007)
Ok - I am already reading the replies as I write this, so let me start this first post by saying to all who will write after me who think this has to be a crock, this has to be the users fault, how can you possibly drive, call a friend, and not know you are doing it, etc,etc,etc. - IT IS 100% TURE.
I would not believe it myself if I have not seen it time and again from my wife, who has been on Ambien for years now. It happens on rare occasions under heavy stress, on days she does not eat and takes the stuff on an empty stomach, and sometimes for no apparent reason such as those above.
She wakes the next morning telling me she has no clue what happened after she fell asleep, and I believe her because. She can't remember a thing from any of the times this has happened, not a clue. I have to show her the phone bills or show her the stuff we got at the store and she can't argue the point, but on numerous times, she has done things and never remembered it at all. She even has asked me questions like "why did you take apart the lamp" and that is the only way I know she was too far gone when she got out of bed at midnight and took it apart- cause she has to ask and does not remember.
This really does happen. Not because of drinking (as least not in her case) not because of taking too many pills- just after she falls asleep, or about 30 minutes after taking the stuff, she falls into a haze (Sometimes- I can see it in her expression that she is in this phase of almost toally gone, but still awake.) I know that when she wakes she wont have a clue as to what she did the night before, and as scary as it sounds, that included driving on a few nights when I had no clue she was too far gone not to remember the next day. The hard part is that she is perfectly lucent, clear as a bell on some nights, and you could not guess that she was "out of it" when these drugs take complete hold- - still awake, sometimes she never gets to sleep and just passes into this while still awake, and the next day says what happened after...
She has re-arranged furniture, made calls, and has no memory at all the next day that not only did she do these things, but did them and completely was seemingly appearing wide awake- not a hint of sleepiness in her actions, only to have no clue she did anything like this the next day.
I know how strange it sounds, but even her friends have called her the next day on these occasions and asked her why she called so late and talked for an hour, and she cant remember a thing.
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chuck goolsbee 9:50PM (3/14/2007)
"Ask your Doctor if sleep-driving is right for you."
--chuck
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paul34 10:14PM (3/14/2007)
wow, that's pretty friggin scary. What if you did "worse" things? Hell, you could end up pregnant/impregnating someone with this stuff. Not good!
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Barney 10:16PM (3/14/2007)
I assume TTW that you had already obtained medical help for your wife. Is she still taking the pills? Hopefully not and I expect she must have been horrified. Personally I take no drugs of any description but can't judge those that have to. The key word is "have" to.
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Kevin White 10:38PM (3/14/2007)
Why would they not include the anti-histamines? Dimenhydrinate, Diphenhydramine, Doxylamine, Chlorpheniramine among others. Ambien has the supposed advantage of little or no hangover the next day, while Doxylamine can make me feel sedated well into the next morning; but as a deliriant I don't see how these are exempt, especially as they're including such old drugs as Secobarbital and Triazolam. Add to it that many anti-histamine sedatives are available over the counter... strange.
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Nick 10:44PM (3/14/2007)
As a physician, we were taught in medical school that patients are not supposed to take medications for sleep every day- that soporifics disturb the stages of natural sleep while you are on the drug.
Just guessing, but I would assume that what is happening with Ambien is a variant of the amnestic effect that is seen with some benzodiazapenes such as Versed- you can be conscious, but sedated during a procedure with Versed, but you won't remembr it afterwards. That effect seems to be magnified with some people with Ambien. For this to be true though, I would not think drinking alcohol with Ambien would make it worse- I would think alcohol and Ambien would result in oversedation and less of the sleep walking phenomenon. Alcohol and Ambien together is probably a decent way to half heartedly try to kill yourself.
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Atomicbri 11:18PM (3/14/2007)
Wow My sister-in-law is a nurse in an assisted living facility and she always tells us stories about several people who are on the different sleep aids. One lady makes a 7 course meal! and cleans up after herself. She has gained 50 lbs and was concerned as to why, she had no clue she was eating after "going to sleep" on her sleep meds. Well my sis-in-law contacted her doctor and since they have halved her dose to take it only when she can not sleep. She can do that though cause she can dedicate the 8hrs since she does not work and is in this facility. I feel sorry for the people on it who have an "9-5" job and a life with sleeping problems, thinking they are getting help when in reality, they never went to bed! Wild!
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iQuack 2:17AM (3/15/2007)
I'm more afraid of the cell phone blabbies I see driving with one hand on the steering wheel and the other hand holding a damn cell phone.
Those assholes should all crash into each other.
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Chris MacMillan 10:34AM (3/15/2007)
Yes, the warning needs to be on this medication. My wife has chronic pain due to type 2 diabetes and has had problems with Ambien and Ambien CR, she doesn't drive but eating and mail ordering off television, strange but true, have be problematic. Changed to Lunesta and the problems have gone away. My research leads me to believe that it is an Ambien problem not so much a sleep aid problem.
Just my 2 cents worth:)
Chris
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synergeist 1:10PM (3/15/2007)
Patients using Ambien or Ambien CR may experience the following symptoms: Significant weight-gain and regretful purchases of Toyota vehicles...
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lalaland 4:25PM (3/15/2007)
I took Ambien on a flight to Europe and I woke up flying the plane.
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Karen 5:58PM (3/15/2007)
I've been taking Sonata for months - to counteract the effects of Prednisone. I've woken up most mornings to find to pots & pans in the sink &, once, a large burn on my hand. Accordingly, my calorie consumption & jean size has increased substantially. I've also made phone calls plus sent emails & text messages without recollection. No alcohol is involved. NOW I'm finally being taken seriously.
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bhamm 8:36PM (3/15/2007)
My complaint after taking Ambien during treatments for HepC, was the horrific nightmares and the sensation of my brain tremoring that kept up for a year after stopping the Ambien.
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Ford Mustang 4:21PM (3/17/2007)
I sleep-drive all of the time. It's known as going to work in the morning.
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Stacie Harrison 5:12AM (10/25/2007)
I wish this were an amusing thing. As a nurse, I was aware of patients doing unusual things such as taking out IVs or using profanity but I was clueless about the issue of sleepdriving. I work nights and in order to sleep on my days off I took an Ambien. I took it at 10 pm and "awoke" at 2am with blue lights behind me. Now I've been charged with a DUI drugs even though I had no alcohol in me and no other drugs. I have absolutely no memory of getting out of bed, getting dressed or getting in the car. Thank God I didn't hurt anyone or myself. Warning labels simply aren't enough. It really should be taken off the market. I know I will never take it again and I have a hard time giving it to my patients. If someone you know or love is taking this medication, please take it seriously and hide the keys and lock the doors...
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