FDA Requests Stronger Ambien Warnings

In addition to sleep-driving, sleep-eating emerging as side effects of Ambien, Lunesta and similar hypnotic-sedative sleeping pills, there is also sex while sleeping.

The FDA is asking the makers of Ambien and similar drugs to strengthen the label warnings on the drugs to disclose these and other risks.


The 13 drugs involved are: Ambien and Ambien CR, made by Sanofi Aventis; Butisol Sodium, made by Medpointe Pharm HLC; Carbrital, made by Parke-Davis; Dalmane made by Valeant Pharm; Doral made by Questcor Pharms; Halcion, made by Pharmacia & Upjohn; Lunesta, made by Sepracor; Placidyl and Prosom, made by Abbott; Restoril, made by Tyco Healthcare; Rozerem, made by Takeda; Seconal, made by Lilly.

There's other side effects too:

Last December, the FDA sent letters to the drug makers, asking them to revise their product labels to include warnings about the potential for severe allergic reactions -- called anaphylaxis -- and severe facial swelling -- called angioedema.

At that time, the FDA also asked the manufacturers to add warnings about complex sleep-related behaviors, including sleep-driving, making phone calls, and preparing and eating food or having sex while asleep, Katz said.

I wonder if Colin Powell would say today as he did in 2003:

"They're a wonderful medication -- not medication. How would you call it? They're called Ambien, which is very good. You don't use Ambien? Everybody here uses Ambien."

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  • Display: Sort:
    Sleep-drive, sleep-eat, sleep-sex?! (none / 0) (#1)
    by sarcastic unnamed one on Wed Mar 14, 2007 at 03:56:56 PM EST
    How about sleep-work? Now that would be a big seller!

    Sleep-work? (none / 0) (#2)
    by Adept Havelock on Wed Mar 14, 2007 at 04:14:30 PM EST
    Sleep-Work?  No thanks, enough of my colleagues do that anyway.  They don't even need meds.

    Having not had (none / 0) (#3)
    by Deconstructionist on Wed Mar 14, 2007 at 04:22:07 PM EST
    sexual gratification while asleep since I was 13, I may have to visit my doctor. I usually wait until 5 minutes after sex to sleep these days. Now, if someone can just come up with a drug to make this work for my wife we're talking.

    sleeping pills (none / 0) (#4)
    by diogenes on Wed Mar 14, 2007 at 11:01:11 PM EST
    I wonder how many people have to take these meds for one to have this sort of reaction?
    If Restoril and Dalmane are on this list, why not valium or xanax?  This sure looks like a witch hunt against sleeping pills, as opposed to a desire to inform people about the theoretical low risk of having the equivalent of an alcoholic blackout.

    Valium is not the same catagory; it is a good (none / 0) (#6)
    by Molly Pitcher on Fri May 23, 2008 at 12:59:13 PM EST
    muscle relaxant.  I can take half of the smallest dosage and sleep without pain from spinal damage.

    Xanax used to be given for panic attacks; it can causepanic attacks.


    Angioedema = facial swelling! (none / 0) (#5)
    by FoxholeAtheist on Fri May 23, 2008 at 12:56:49 PM EST
    Is that why McCain's face usually looks twice the size of a normal adult face? It seems to have subsided a bit lately. I just assumed he had some 'work' done, although it still doesn't look quite right.

    Remember when GHW Bush was on Larry King and they both chatted up the merits of Halcyon?

    Don't a lot of sleep meds interfere with memory as well?

    Amnesia, here it is: (none / 0) (#7)
    by FoxholeAtheist on Fri May 23, 2008 at 01:05:52 PM EST
    "In my practice, 10 percent of people who take sleeping pills have reported some kind of side effects that involve amnesia. The only way they know it is that a family member tells them about it," he said. "If somebody lives on their own, they don't know it." From the WaPo article cited in the post.

    I imagine, if an Ambien user lives with another Ambien user, that would compound the amnesia.

    Who else on the camapaign trail is showing signs of side-effects associated with taking sleep meds?