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Takeda Submits Application For Insomnia Drug Remelteon In Japan

This article was originally published in PharmAsia News

Executive Summary

On Feb. 29, Takeda applied for approval for sleeping pill remelteon (TAK-375) with Japan's Ministry of Health, Labor and Welfare. Remelteon works by selectively targeting two melatonin receptors in the brain, MT1 and MT2. By acting on these receptors, the body's sleep-wake cycle is regulated and physiological sleep is promoted. Because it did not show evidence for potential abuse or dependence in clinical studies, remelteon is the first insomnia medication not regulated by the U.S. Drug Enforcement Administration. Approved by the U.S. FDA in 2005, remelteon is marketed under the brand name Rozerem. Takeda also applied for approval with the European Medicines Agency in March 2007. (Click here for more - Japanese language



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