Japanese drugmaker, Takeda, is celebrating securing US Food and Drug Administration approval for its new insomnia offering, Rozerem (ramelteon).

Rozerem specifically won the green light for the long-term treatment of adults with insomnia. And, as the product has shown no evidence of abuse or dependence, it has not been designated a “controlled substance” by the FDA, which could give it a significant leg up in the market for insomnia treatments. All other prescription sleep drugs, including Sanofi-Aventis and Sepracor’s rival offerings Ambien (zolpidem) and Lunesta (eszopiclone), are classified as “Schedule IV controlled substances.” Said Thomas Roth, director of the Sleep Disorders and Research Center in Detroit: “[Rozerem]… has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day ‘hangover’ effects.”

The market for sleep drugs is expected to exceed $5.6 billion in 2013 [[17/08/04g]], and analysts are forecasting Rozerem’s sales could top $898 million a year, according to a Reuters report. Ambien brought in 2004 sales of some $1.6 billion, but its performance is expected to be dented by competition from Lunesta, which was launched in April this year [[08/04/05f]].

Takeda says that Rozerem offers a completely new mechanism of action for insomnia, and belongs to the first class of drugs to be developed in 35 years of sleep research. It works by specifically targeting two receptors in the brain, MT1 and MT2, which are located in the area of the brain that controls the 24-hour sleep-wake cycle, and are thought to be critical in the regulation of this cycle. The drug was filed with the FDA in September last year [[24/09/04c]], and is expected to be available for patients by late September this year.