Takeda Pharmaceuticals North America says that its prescription drug Rozerem (ramelteon) 8-mg tablets are now available in pharmacies across the USA for the treatment of insomnia, following the receipt of marketing approval from the US Food and Drug Administration earlier this year [[25/07/05a]].
According to the firm, the product, which can be prescribed for long-term use in adults, represents the first prescription insomnia medication with a novel therapeutic mechanism of action in 35 years. Its unique action selectively targets two receptors located in the brain's suprachiasmatic nucleus, an area referred to as the body's "master clock" as it regulates 24-hour rhythms such as the sleep-wake cycle, the firm noted.
In what represents an important advantage over existing therapies, clinical evaluation to date indicates that Rozerem is the first and only prescription sleep drug with no evidence of abuse and dependence in clinical studies. Consequently, the agent has not been designated as a controlled substance by the US Drug Enforcement Administration, as is the case with all other prescription drugs for insomnia, including Sanofi-Aventis and Sepracor's rival offerings Ambien (zolpidem) and Lunesta (eszopiclone).
Insomnia, which is defined as difficulty initiating and/or maintaining sleep with accompanying daytime disability, affects more than 130 million people in the world's seven major pharmaceutical markets. However, the market remains largely untapped as only a small proportion of insomniacs currently seek professional help for their condition. Still, 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.