The sale for Ambien (Zolpidem tartrate, original version) was %1.7 billion last year
and the treatment accounted for more than 64 percent of sleeping pill sales
worldwide. But its patent protection will expire in 1-2 years. Sanofi was hoping to
convert 50 percent of the Ambien users to Ambien CR before the patent on the
original product expires.
Ambien is indicated for only short-term treatment of insomnia. Ambien has been
shown to decrease sleep latency and increase the duration of sleep for up to 35
days. Ambien can be prescribed in quantiities exceeding a one-month supply. [1]
Ambien CR is non-narcotic and non-benzodiapzepine for the treatment of insomnia
with a similar safety profile to Ambien and a new indication for sleep maintensance,
in addition to sleep induction. [2] According to the news, Ambien CR is the first and
only extended-release prescription to help people with insomnia fall asleep fast
without a significant decrease in next day performance.
Ambien CR has two layers. One layer dissolves quickly to induce the effect while
another one dissolves slowly to provide a continuous sleep.
Other sleeping pills at experimental stages: indipion (Neurocrine Biosciences Inc.)
and gaboxadol (Merck and Lundbeck).
Market Competition
Transcept Pharmaceuticals announced that the FDA has accepted for review the
NDA for its IND Intermezzo, potentially indicated for the treatment of sleep
maintenance insomnia. It is a low-dose sublingual tablet formulation of
benzodiazepine agonist zolpidem. [3]
It has been estimated the total non-benzodiazepine prescription market in the U.S. for
the treatment of insomnia in 2006 was approximately $3.4 billion, growing to $3.8
billion by 2011. Ambien/Ambien CR(TM) (zolpidem tartrate) and generic zolpidem
tartrate are the dominant prescription drugs totaling more than 70% of the market in
2006. [4]
ALL RIGHTS RESERVED 2008
REFERENCES
[1] Ambien, buy-adipex-ambien-phentermine-online.com, Sept 6, 2005.
[2] Press Release, Ambien CR (Zolpidem Tartrate Extended-Release Tablets) CIV
Receives FDA Approval for the Treatment of Insomina. Sept 6, 2005 [3] Transcept:
Intermezzo accepted for review by FDA www.pharmaceutical-business-review.com
December 18 2008 [4] redhotpennystock.com: PAVC, NVD, SPNG, PINR, IDT, ALIN
"Redhotpennystock.com alert" www.tradingmarkets.comDecember 22, 2008
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Ambien CR - A Sleeping Pill
US FDA approved Sanofi-Aventis' Ambien CR for insomina. The marketing approval will allow Sanofi-Aventis to launch Ambien CR this summer to compete with Sepracor's Lunesta and Takeda's Rozerem.
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