A new sleeping Aid; in it's own class?

By pharmapsyche · Mar 9, 2006 · ·
  1. pharmapsyche
    Sleeping In: Takeda Pharma Holds Off on New Anti-Insomnia Drug

    October 06, 2005

    NEW YORK -- Takeda Pharmaceutical will delay the consumer launch of its new anti-insomnia drug Rozerem until 2006, the company said this week.

    The drug received approval from the Food & Drug Administration in July. It was introduced to about 1,000 drug reps at a launch meeting two weeks ago, according to Rich Daly, Takeda's svp-marketing.

    Those reps are telling doctors about Rozerem's two main differences to other sleep drugs—that Rozerem has a new way of acting on the brain, and that it is not addictive. The drug's new mechanism of action is to flip a “sleep switch” in a patient's head that turns off signals calling for the brain to stay awake; older drugs are mostly sedatives of one sort or another.

    Daly declined to describe what the consumer advertising would look like, although he did mention that one possible route would be to hammer a safety message around a “Sleep without the worry” theme. He did not rule out using any type of media.

    Daly said the company would analyze doctors' reactions to the new drug before going ahead with DTC ads.

    “We're doing a lot of ongoing evaluation work,” before launching to consumers, he said.

    The Rozerem Web site currently uses the headline “A new sleep therapy in a class by itself.”

    One interesting twist for the company, Daly said, is that the launch is intended to grow the whole category, but a recent rival launch of Sepracor's Lunesta drug has not achieved that in Takeda's view. “It's not growing the market,” Daly said of Lunesta.

    Sepracor has also previously said it wants to grow the category. In August, Sepracor executive director of central-nervous-system marketing Timothy Healey told Brandweek that Lunesta, at a 12.9% share of new prescriptions, had taken 7.5 share points off market leader Ambien (from Sanofi-Aventis), which was down to 60.5%.

    The market became even more confused in September when Sanofi-Aventis got approval for Ambien CR, a controlled release version of its blockbuster that keeps patients asleep in addition to simply inducing sleep.

    A failure by any of these companies to grow the category would be bad news for several companies in addition to Takeda, Sepracor and Sanofi.

    Among the other firms with sleep drug launches in the pipeline are Pfizer (indiplon compound), Merck (gaboxadol compound), Somaxon (Silenor brand), and GlaxoSmithKline (Requip brand, a restless legs syndrome therapy that has drowsy side effect).

    --Jim Edwards

    ...with this article, it makes me wonder if new sleeping aids are instore soon for the population, since insomina medication is in the top 5 of the most prescribed medications, I'm sure pharmaceutical companies are working on substances for this illness...

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  1. sands of time
    I have seen reps talk about this stuff, and it does sound impressive, but it's effectiveness is somewhat questionable. Its about 10X more potent than melatonin, and it's an agonist of the melatonin receptors. It has not been fully established that melatonin is the primary sleep hormone/nuerotransmitter/whatever the hell it is, but rozerem has potential.

    I think doctors are gonna love this stuff because it's gonna take out the risk of abuse and addiction. Benzos make horrible sleeping pills because eventually you have to cut the patient off the stuff, and the problem will be even greater. Ambien and the likes may be non-narcotic, but that doesn't mean they don't have abuse potential, or the potential for addiction. Ambien also can cause amnesia, and other problems. To much can put the patient in a very weird, drunk state of mind. Swim has heard many a phone calls of patients complaining that they're sleeping pill made them feel funny or completely wasted. Imagine elderly people driving on this stuff...

    I think rozerem will usher in a new age of treating sleeping problems. I'm not sure how effective it will be for someone with severe sleeping problems, but it is quite safe for patients with minor sleeping problems. As far as I'm concerned, this stuff appears to be safe enough to be sold OTC.
  2. pharmapsyche
    I've tried Melatonin 3mg. time realsed, since they are avalible OTC. Actully, tonite will be my 12th nite taken them in a row. I defiantly think Melatonin does help with helping REM and the whole sleeping pattern, but then again I always end up asking myself if I am just useing it at a Placbo Effect, I guess i'll never really know...but 10 times more potent than Melatonin, should be interesting, espeically if we ever come to find that Melatonin IS the primary sleep hormone!
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