FDA Approves Sepracor Lunesta

Lunesta (eszopiclone), a new non-narcotic prescription sleep aid from Sepracor, received FDA approval on December 15, 2004.

Lunesta represents a new treatment option for those suffering from insomnia; Lunesta not only helps people fall asleep quickly, it helps them sleep restfully through the night, with fewer interruptions, and wake up refreshed and ready to start the day. While current sleeping aids are generally limited to seven to 10 days of use, Lunesta is the first and only prescription sleep aid not limited to short-term use. Physicians can prescribe Lunesta for as long as they determine their patients may need it.

Is it a wake-up call for the sleeping pill market? With Wednesday's approval of Sepracor's new drug, Lunesta, a taboo in the use of sleeping pills has been broken. Lunesta is the first sleeping pill whose label will not recommend it be taken for only 7 to 10 days.

The approval could clear the way for people to use Lunesta, and possibly similar drugs, for longer periods and turn sleeping pills from a market laggard into a much more widely used category of medications, sleep specialists said. "That's going to make a lot of people more comfortable prescribing longer term, because the data exists," said Dr. Michael L. Perlis, an associate professor and director of the sleep research laboratory at the University of Rochester, who has consulted for Sepracor and other drug companies.

Lunesta is a sedative-hypnotic drug used to treat insomnia. While the exact mechanisms of Lunesta are unknown, the medication is believed to improve the brain’s reception of gamma-aminobutyric acid (GABA), a neurotransmitter responsible for inhibiting excitement and promoting the state of calm essential to the body’s preparation for sleep.

Lunesta® (eszopiclone) is a prescription sleep aid that helps the majority of people get back to sleeping the way they want to,* so they can wake up feeling rested and ready to face the day.

LUNESTA has been extensively studied in patients with short-term and chronic insomnia.

While some sleep aids are approved to help you fall asleep and some help you stay asleep, LUNESTA is approved to do both — so you can get the restful sleep you need.