Sepracor says that its insomnia drug, Lunesta (eszopiclone), is now available in the US.
The firm says that Lunesta is the first and only sleep aid approved by the US Food and Drug Administration for the long-term treatment of insomnia, and that it is the first treatment in its class that has been shown to not only help patients fall asleep quickly, but also sleep all through the night.
Lunesta – formerly known as Estorra – won FDA approval late in 2004, based on data from a six-month 788-patient trial [[17/12/04d]], but its launch was delayed earlier this year after the agency failed to complete the process classing Lunesta as a schedule IV controlled substance [[12/01/05b]].
Insomnia, which can include difficulty falling asleep as well as difficulty maintaining sleep through the night, affects an estimated 100 million adults in the US alone. Symptoms include difficulty falling asleep and awakening frequently during the night. If left untreated, it may become progressively worse and in turn, potentially affect a person's emotional, mental and physical health.