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    Friday, December 17, 2004

    Claire de Lune: The FDA has just approved a new sleeping pill, called Lunesta:

    'This novel non-benzodiazepine[non-valium-like -ed] sleep aid provides a new option for the millions of Americans with chronic insomnia. Unlike all other available prescription sleep aids, which are generally indicated for short-term use, eszopiclone has been studied and approved for use when longer-term treatment is needed,' said Andrew Krystal, M.D., Director of the Sleep Disorder Research Laboratory and Insomnia Program at Duke University Medical Center, Durham, NC. 'The six-month, double-blind, placebo-controlled study of eszopiclone provides unprecedented evidence of sustained efficacy. There were statistically significant improvements in patient-reported measures of sleep onset and sleep maintenance versus placebo for the entire duration of the study with no evidence of tolerance.' [Translation: People could take it for six months without "getting used to it" as my patients would say.]

    LUNESTA is indicated for the treatment of patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night (sleep maintenance difficulty).

    'The approval of LUNESTA makes an important treatment option available for patients who have trouble sleeping. Insomnia can include difficulty falling asleep and/or staying asleep. LUNESTA is an important advance for doctors and patients alike, as it can provide sleep efficacy, even over the long term,' said Thomas Roth, Ph.D., Director of the Sleep Disorders and Research Center at Henry Ford Hospital, Detroit"

    The data the FDA considered:

    The LUNESTA NDA contained a total of 24 clinical trials, which included more than 2,700 adult and older adult (ages 65 and older) subjects, and more than 60 preclinical studies. Sepracor conducted six randomized, placebo- controlled Phase III studies for the treatment of chronic or transient insomnia in both adult and older adult patients and included these studies as part of the NDA package, which served as the basis for the FDA's approval of LUNESTA.

    The drug, eszopiclone, is the mirror image (as Nexium is to Prilosec) of a drug already in use in Europe, called zopiclone. The Air Force once did a compairson of zopiclone to other sleeping aids and found it the most effective:

    The sleep-inducing power of the medications before psychomotor testing was zopiclone > zaleplon > melatonin > temazepam. The corresponding effect after psychomotor testing was zopiclone > melatonin > zaleplon > temazepam.

    Suppposedly, the new drug, eszopiclone, had fewer side effects and isn't addicting. Although we won't know how true that is until it's been on the market and used by many people. Detailed, unhyped information about the drug can be found here. The most common side effect : bitter taste.

    It's nice to have a non-addicting, well-tolerated drug to treat insomnia, but the trouble is that insomnia is most often a symptom of some deeper lying problem - usually anxiety or depression. Treating the insomnia without addressing the underlying cause doesn't solve anything. In fact, it only makes it easier to ignore the underlying problems longer, potentially making things worse. But, the company plans to launch a direct to consumer ad campaign (of course!) so expect this to be the next "miracle pill" along with that long-acting enhancement pill and the little purple indigestion pill.

    UPDATE: I stand corrected:

    You write:

    The drug, eszopiclone, is the mirror image (as Nexium is to Prilosec) of a drug already in use in Europe, called zopiclone. The Air Force once did a compairson of zopiclone to other sleeping aid and found it the most effective:

    Nexium actually isn't the mirror image of Prilosec. It's the pure S-isomer, whereas Prilosec is a racemic mixture. Based on the name, I'd guess that that's the relationship between eszopiclone and zopiclone as well.

    That is correct.

    UPDATE II: Some experience from Canada:

    It is also available in Canada (trade name Imovane). I use it in my ICU patients a fair bit to try and improve their sleep. And on a personal note; it is the easiest way to readjust your circadian rhythm after flying - zopiclone for 3 nights post flight, and you are golden.

    posted by Sydney on 12/17/2004 06:34:00 AM 0 comments


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