Source: FDA, National Drug Code (US) Revision Year: 2020
LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-6(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure:
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: calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.
| Dosage Forms and Strengths |
|---|
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LUNESTA is available in 1 mg, 2 mg and 3 mg strengths for oral administration. LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side. LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side. LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side. |
| How Supplied |
|---|
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LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side, and are supplied as: NDC 63402-193-10 bottle of 100 tablets LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side, and are supplied as: NDC 63402-191-10 bottle of 100 tablets LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side, and are supplied as: NDC 63402-190-30 bottle of 30 tablets |
| Drug | Countries | |
|---|---|---|
| LUNESTA | Canada, Japan, United States |
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