Japan's Takeda has won FDA approval for Rozerem, a new sleep drug that will be the first prescription drug for insomnia not classified as a controlled substance. The approval is a coup for Takeda, positioning it to enter the fast-growing sleep drug category behind Sepracor's Lunesta. Neurocrine Bioscience and Merck are also each developing a new sleep drug, which they hope will compete for a growing, multibillion-dollar market that for years has been dominated by Ambien. A controlled-release form of Ambien is also in the works.
- read this report from Japan Today for more