Sleep Aids and Severe Side Effects

There was an interesting article about Lunesta up the other day on The Examining Room of Doctor Charles.

Says drcharles:

I received a letter today from Sepracor, the manufacturers of Lunesta,
a popular sleep aid indicated for the treatment of insomnia. Many
doctors are hesitant to prescribe sleep aids, partly because of their
often habit-forming nature and potential side effects. Sepracor’s
letter discussed labeling changes approved by the FDA. The new labeling
will include warnings about severe allergic reactions that may occur
during sleep, and sleep-driving or other complex behaviors (e.g.
preparing and eating food, making phone calls, or having sex) with
associated amnesia for the event.

From an FDA press release a few weeks old:

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)

Dr. Charles is right to point out that severe reactions to these medications are rare; but even so, it does make you take pause and wonder if non-pharmacologic alternatives are the better way to go, whenever possible.

If you’re interested in learning more on this subject, you can listen to the Health Hacks podcast interview I recently recorded. I do talk in that podcast about cases I’ve seen.

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Michael Breus, Ph.D - The Sleep Doctor is a Diplomate of the American Board of Sleep Medicine and a Fellow of The American Academy of Sleep Medicine and one of only 168 psychologists to pass the Sleep Medical Specialty Board without going to medical school. Dr. Breus is a sought after lecturer and his knowledge is shared daily in major national media worldwide including Today, Dr. Oz, Oprah, and for fourteen years as the sleep expert on WebMD. Dr. Breus is the bestselling author of The Power of When, The Sleep Doctor’s Diet Plan and Good Night!

3 thoughts on “Sleep Aids and Severe Side Effects

  1. Do not purchase the shares of Covidien (formerly Tyco Healthcare).
    Tyco Healthcare BROKE THE LAW. They deceived the FDA.
    Instead of fixing their products, they covered things up and shreaded important documents. They fired all the potential whistle blowers.
    This company is another Enron.

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