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For the estimated 70 million people in the United States suffering from insomnia the availability of a novel treatment option would be welcome relief. Takeda, which recently submitted an NDA to the FDA, hopes its compound, ramelteon (TAK-375), will meet that challenge. Ramelteon is a novel selective melatonin (ML-1) receptor antagonist developed by Takeda for the treatment of insomnia. According to the firm, this is the first new mechanism of action to be developed in 35 years in the area of sleep research.