Approved December 2004
Lunesta (eszopiclone formerly referred to as Estorra) is a nonbenzodiazepine hypnotic agent approved for the long term treatment of insomnia and sleep maintenance.
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).
Eszopiclone was designated as a Schedule IV controlled substance in April 2005 by the Federal Register. It should not be used in conjunction with other prescription or nonprescription sleep aids, by pregnant women, or by patients with known psychiatric illness without medical supervision. Patients taking eszopiclone, or any hypnotic agent, may develop dependence and experience withdrawal symptoms when discontinuing use.
The product is available in 1 mg, 2 mg, and 3 mg tablets. The recommended starting dose for Lunesta for most non-elderly adults is 2 mg immediately before bedtime. Dosing can be initiated at or raised to 3 mg if clinically indicated, since 3 mg is more effective for sleep maintenance.
For elderly patients whose primary complaint is difficulty falling asleep is 1 mg immediately before bedtime. In these patients, the dose may be increased to 2 mg if clinically indicated. For elderly patients whose primary complaint is difficulty staying asleep, the recommended dose is 2 mg immediately before bedtime.
FDA approval of Lunesta was based on results from six clinical trials enrolling a total of 2100 subjects with chronic and transient insomnia. The FDA's decision to approve Lunesta for the long-term treatment of insomnia was based on a six-month, double-blind, placebo-controlled trial enrolling 788 subjects. The total NDA for Lunesta contained data from a total of 24 clinical trials.
The treatment of chronic insomnia was established in five controlled studies. Three controlled studies were in adult subjects, and two controlled studies were in elderly subjects with chronic insomnia.
Adverse events associated with the use of Lunesta may include (but are not limited to) the following:
Lunesta is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is the S-isomer of the marketed non-benzodiazepine rapid-acting hypnotic zopiclone. Lunesta raises levels of an amino acid called Gamma-Aminobutyric Acid (GABA). GABA slows down brain activity so that your mind and body can relax, enabling you to fall asleep and stay sleep.
For additional information regarding Lunesta or insomnia, please contact The Lunesta Web Site
The Lunesta (eszopiclone) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.