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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.

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    • 1 Second Ago
      • 8 Years Ago
      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!
      • 8 Years Ago
      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!
      • 8 Years Ago
      Patients using Ambien or Ambien CR may experience the following symptoms: Significant weight-gain and regretful purchases of Toyota vehicles...
      • 8 Years Ago
      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.
      • 8 Years Ago
      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.
      • 5 Years Ago
      I found this article on google because I almost got into an accident this morning due to me sleep-driving. I don't take any sleep aids or any medication for that matter. I woke up about 10 minutes into my drive to work and I was in the left lane of a two lane road with an oncoming car locking up its brakes. If I would have slept a second longer I would more than likely not be alive to write this. What I'm looking for is information on non-under chemical influence-sleep driving. If anyone could help that would be awesome.
      • 7 Years Ago
      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...
      • 8 Years Ago
      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.
      • 8 Years Ago
      "Ask your Doctor if sleep-driving is right for you."


      • 8 Years Ago
      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.