Sleep Disorders

Eszopiclone - New Drug's A Sleeper

New study shows Lunesta does not become addictive even after 12 months.

Study of eszopiclone in insomnia during perimenopause and early postmenopause.

Lunesta (eszopiclone) is a nonbenzodiazepine hypnotic agent. (Ambien and Sonata are also nonbenzodiazepine agents.) It should be used only when the recipient can devote a full night's sleep because it will take that long to wear off. One rap against Ambien was that while it helped people get to sleep, they woke up during the night. Lunesta may be better in that respect. Also, while Ambien was officially supposed to be taken for only 10 days straight (although some doctors ignored that limit), Lunesta is approved for longer durations. Trials suggest that people don't get addicted to Lunesta.

The pharmacology of eszopiclone is not well understood. Chemically, eszopiclone is a short-acting hypnotic agent that is a stereoselective isomer of the agent zopiclone. Racemic zopiclone (both forms of the isomer) has been on the market in Europe since 1992. The eszopiclone isomer expected to be better as a medication. Early tests have indicated that it is an effective sleep medication.

Sepracor Inc. received Food and Drug Administration approval for Lunesta (eszopiclone) for the treatment of insomnia.

Formerly known as Estorra, Lunesta will be sold in 1 mg, 2 mg and 3 mg tablets. The recommended dosing to improve sleep onset and/or maintenance is 2mg or 3mg for adult patients (aged 18-64 years) and 2mg for older adult patients (over 65). The 1mg dose is for sleep onset in older adult patients whose primary complaint is difficulty falling asleep.

Study on the efficacy and safety of eszopiclone.

According to Sepacor:

Lunesta is indicated for the treatment of patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night (sleep maintenance difficulty).

The New York Times reports:

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.

Sepracor, the maker of Estorra™ (eszopiclone) reports:

The Prescription Drug User Fee Act (PDUFA) date for the resubmitted Estorra™ brand eszopiclone New Drug Application (NDA) is December 15, 2004. A PDUFA date is the date by which the U.S. Food and Drug Administration (FDA) is expected to review and act on an NDA submission. On February 27, 2004, Sepracor received an "approvable" letter from the FDA for its NDA for Estorra™ for the treatment of insomnia characterized by difficulty falling asleep and/or difficulty maintaining sleep during the night and early morning. Contingent upon approval from the FDA of the Estorra™ NDA, Sepracor would expect the recommended dosing to achieve sleep onset and maintenance to be 2 mg and 3 mg for adult patients, 2 mg for elderly patients with sleep maintenance difficulties, and 1 mg for sleep onset in elderly patients whose primary complaint is difficulty falling asleep. The FDA has not requested additional clinincal or preclinical trials for approval.

October 24, 2003 09:03:52 AM PDT , HealthDay

A new drug called eszopiclone (trade name Estorra) works in treating long-term insomnia, says a study in the Nov. 1 issue of Sleep.

During the six-month study, led by Duke University Medical Center, the drug was given nightly to patients with chronic insomnia. The patients taking the drug showed significant improvement in their ability to fall asleep and to stay asleep. They also experienced better quality of sleep.

There was no evidence of loss of drug effectiveness over time, the study says.

The improvement in sleep achieved by the patients taking the drug were associated with consistent improvements in the patients' ratings of their capacity to function well during the day.

This is the first time that any sleep medication has been shown to consistently improve all the components that define insomnia.

The double-blind, placebo-controlled study included 788 people aged 21 to 69. Those taking the drug were given 3 milligrams a night of eszopiclone.

"I believe that this study is a milestone for research into insomnia treatments," lead author Dr. Andrew Krystal, an associate professor of psychiatry and director of the Sleep Research Laboratory and Insomnia Clinic at Duke, says in a prepared statement.

"It greatly extends the period of time that a medication has been definitively shown to help people suffering from insomnia and it establishes that studies of longer-term drug treatment of insomnia are not only feasible but can be safely performed," he says.

Prior to this study, the longest large-scale, placebo-controlled study of a sleep medication for insomnia lasted five weeks.