LUNESTA eszopiclone tablet coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

ESZOPICLONE

Composition:

ESZOPICLONE 2 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

LUNESTA - ESZOPICLONE TABLET, COATED
ST MARYS MEDICAL PARK PHARMACY
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LUNESTA (ESZOPICLONE) TABLETS
1 MG, 2 MG, 3 MG
R ONLY
C-IV
PRESCRIBING INFORMATION
DESCRIPTION:
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
4-methylpiperazine-1-carboxylate. Its molecular
weight is 388.81, and its empirical formula is C
H ClN O . 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.
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS
The precise mechanism of action of eszopiclone as a hypnotic is
unknown, but its effect is believed to
result from its interaction with GABA-receptor complexes at binding
domains located close to or
allosterically coupled to benzodiazepine receptors. Eszopiclone is a
nonbenzodiazepine hypnotic that is
a pyrrolopyrazine derivative of the cyclopyrrolone class with a
chemical structure unrelated to
pyrazolopyrimidines, imidazopyridines, benzodiazepines, barbiturates,
or other drugs with known
hypnotic properties.
PHARMACOKINETICS
The pharmacokinetics of eszopiclone have been investigated in healthy
subjects (adult and elderly) and
in patients with hepatic disease or renal disease. In healthy
subjects, the pharmacokinetic profile was
examined after single dos