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  • FDA: sleep driving

    Article....

    FDA: Sleeping pills can cause 'sleep-driving'

    • FDA orders 13 sleep-disorder drugs to carry stronger warnings
    • Drugs include the popular Ambien and Lunesta
    • Risks include driving, eating and talking while asleep with no recollection later

    WASHINGTON (AP) -- 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 crashed his car into a security barrier outside the U.S. Capitol after taking Ambien and a second drug, Phenergan, which also acts as a sedative. He has said he had no memory of the event.

    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 another sedating drug, or 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.
    Dr. Mordrid
    ----------------------------
    An elephant is a mouse built to government specifications.

    I carry a gun because I can't throw a rock 1,250 fps

  • #2
    Prescription sleep aides make my wife loopy and wide awake. I kid you not. She got a couple of Ambian CRs when she was in the hospital to birth Avery and she was unable to sleep for 4 hours afterward.
    “Inside every sane person there’s a madman struggling to get out”
    –The Light Fantastic, Terry Pratchett

    Comment


    • #3
      Just last Sunday good friend of mine stopped by, had a couple of beers….. .

      Anyway, he told me what had happen to him just the other day, he was driving next to a park (lucky for him) and next thing he knows, when the car went off the street and hit the curb, he woke up!
      Luckily for him there was plenty of grass and no trees near by, he managed to stop and turn around without anything happening to anyone.
      His wife was telling me that sometimes while having dinner they’ll talk, and all of a sudden, he’s quiet. Guess what is he doing? ….

      I know he takes sleep medications, just not sure what he takes. He’ll be happy to see this article, he’s freaking out at this point.

      .
      Diplomacy, it's a way of saying “nice doggie”, until you find a rock!

      Comment


      • #4
        Sleep? What's that?

        Comment


        • #5
          Want to sleep? Take two Percocet. Found that out when I had some nasty muscle spasms in my neck. The doc prescribed the pills, I went to the pharmacy to get them, then I was asleep almost before my wife could get me home. They rock.
          Lady, people aren't chocolates. Do you know what they are mostly? Bastards. Bastard coated bastards with bastard filling. But I don't find them half as annoying as I find naive, bubble-headed optimists who walk around vomiting sunshine. -- Dr. Perry Cox

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          • #6
            3-6 mg of melatonin puts me out within 20 min if the leg doesn't hurt too bad. If it does 750 mg of vicodin might help.
            Dr. Mordrid
            ----------------------------
            An elephant is a mouse built to government specifications.

            I carry a gun because I can't throw a rock 1,250 fps

            Comment


            • #7
              Originally posted by ND66 View Post
              Just last Sunday good friend of mine stopped by, had a couple of beers….. .

              Anyway, he told me what had happen to him just the other day, he was driving next to a park (lucky for him) and next thing he knows, when the car went off the street and hit the curb, he woke up!
              Luckily for him there was plenty of grass and no trees near by, he managed to stop and turn around without anything happening to anyone.
              His wife was telling me that sometimes while having dinner they’ll talk, and all of a sudden, he’s quiet. Guess what is he doing? ….

              I know he takes sleep medications, just not sure what he takes. He’ll be happy to see this article, he’s freaking out at this point.

              .
              That sounds like narcolepsy. If this is drug induced, he should stop taking them immediately. If it isn't, he should certainly not drive.
              Brian (the devil incarnate)

              Comment


              • #8
                If not related to the meds it sounds more like absence seizures, AKA petite mal seizures. Dropping out as you describe is their hallmark.

                Regardless; IMO he should stop the meds (and driving) and if there is no improvement then it's time for him to see a neurologist, NOT a general practitioner, ASAP.
                Last edited by Dr Mordrid; 15 March 2007, 04:19.
                Dr. Mordrid
                ----------------------------
                An elephant is a mouse built to government specifications.

                I carry a gun because I can't throw a rock 1,250 fps

                Comment


                • #9
                  That's what I told him, see the doctor, NOW!

                  .
                  Diplomacy, it's a way of saying “nice doggie”, until you find a rock!

                  Comment


                  • #10
                    My thoughts of mild acataplexic narcolepsy were reinforced by the patient requiring sleep medication. This is typical, while mild epilepsy (petit mal) is usually unaffected or even improved by sleep medication. You don't mention the age, but petit mal seizures often begin in adolescence, so the neurologist will need to know prior history. Narcolepsy has no specific onset age but can progress.

                    Whatever, he should not drive until the cause has been brought under control, if ever. I would also recommend that he does not consume any non-prescribed drugs (including alcohol, caffeine and nicotine) until diagnosis.
                    Brian (the devil incarnate)

                    Comment


                    • #11
                      Childhood absence epilepsy is distinct from absence seizures in adults.

                      In true childhood absence epilepsy there are typically mutations in the CACNA1H and CAE genes and symptoms typically stop at puberty.

                      In adults the usual causes are genetic, injury, medications, a mass or some disease process.

                      Narcolepsy's most common symptom is hypersomnia, AKA Excessive Daytime Sleepiness, which forces people to fall asleep at inappropriate times (often preceded by head bobbing) and REM sleep disturbances at night.

                      In the former the person isn't likely to sit staring as in absence seizures, they'll fall off the chair (cataplexy).
                      Last edited by Dr Mordrid; 15 March 2007, 08:31.
                      Dr. Mordrid
                      ----------------------------
                      An elephant is a mouse built to government specifications.

                      I carry a gun because I can't throw a rock 1,250 fps

                      Comment


                      • #12
                        Cataplexy occurs in only about 12% of narcoleptics, which is why I specified acataplectic. Total cataplexy, where the patient actually falls, is rare. Partial cataplexy, such as falling over a table you are sitting forward at or dropping an object being held, without actually losing one's balance, is somewhat more common. The main problem is that it is difficult to dx narcoleptic patients unless they do something extraordinary and come forward for help. It is possible that a sizeable proportion of the population is slightly narcoleptic but is never diagnosed. The best estimates, depending on the ethnic background, is 0.05 to 0.1% of the population. It is probable that 80% or more of narcoleptics do not even know they are so as their sleep episodes may last only a second or two and do not include cataplexy. Strange thing: there is a preponderance of narcoleptics born in March in the northern hemisphere.

                        I had a work colleague who was narcoleptic. He was a desk worker and fell gently forward on his desk 3-4 times per day with episodes lasting 5-15 seconds. He was never cataplectic.
                        Brian (the devil incarnate)

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