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"A ruffled mind makes a restless pillow". - Charlotte Bronte

Eszopiclone - Lunesta

National Library of Medicine

Scientific study on eszopiclone

Study of eszopiclone in insomnia during perimenopause and early postmenopause.

Lunesta (eszopiclone) is a nonbenzodiazepine hypnotic agent. (The leading prescription insomnia drugs, including 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 zolpidem (Ambien) was that while it helps people get to sleep, they wake up during the night. Eszopiclone may be better in that respect. Also, while Ambien is officially supposed to be taken for only 10 days straight (although some doctors ignored that limit), Eszopiclone/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.

Formerly known as Estorra, Lunesta is 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 1 mg dose is for sleep onset in older adult patients whose primary complaint is difficulty falling asleep.

According to the manufacturer 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.

Study shows Lunesta does not become addictive even after 12 months.