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LUNESTA (ESZOPICLONE): PRESCRIBING INFORMATION
Lunesta (Eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration.
Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).
Eszopiclone is formulated as film-coated tablets for oral administration. Lunesta tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: colloidal silicon dioxide, calcium phosphate, croscarmellose sodium, lactose, hypromellose, magnesium stearate, polyethylene glycol, microcrystalline cellulose, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.
Lunesta clinical pharmacology
Lunesta clinical trials
INDICATIONS AND USAGE
Eszopiclone (Lunesta) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, Lunesta (Eszopiclone) tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
DOSAGE AND ADMINISTRATION
Lunesta dosage and administration
Lunesta special concerns
Lunesta special populations
Lunesta drug interactions
Lunesta adverse reactions
DRUG ABUSE AND DEPENDENCE
Lunesta drug abuse and dependence
Lunesta (Eszopiclone) 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side, and are supplied as: bottle of 100 tablets; carton of 90 tablets
Lunesta (Eszopiclone) 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side, and are supplied as: bottle of 100 tablets; carton of 90 tablets
Lunesta (Eszopiclone) 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side, and are supplied as: bottle of 30 tablets; bottle of 100 tablets
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Manufactured and distributed by Sepracor pharmaceutical company and its divisions.
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