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ALCHERA Tablets
SCHEDULING STATUS:
S5
PROPRIETARY NAME
(and dosage form):
ALCHERA Tablets
COMPOSITION:
Each tablet contains:
Zopiclone
7,5 mg
PHARMACOLOGICAL CLASSIFICATION:
A.2.2 Sedatives, hypnotics.
PHARMACOLOGICAL ACTION:
Zopiclone is a hypnotic agent, a member of the cyclopyrrolone group of compounds. Its pharmacological properties are:
hypnotic, sedative, anxiolytic, anticonvulsant, muscle-relaxant. These effects are related to a specific agonist action at
central receptors belonging to the GABAa macromolecular complex, modulating the opening of the chloride ion channel.
Zopiclone is rapidly absorbed. Peak concentrations of 30 to 60 ng/mL are reached within 1,5 to 2 hours after the
administration of 3,75 mg and 7,5 mg respectively. Absorption is not modified by food.
Zopiclone is rapidly distributed from the vascular compartment. Plasma protein binding is weak (approximately 45%)
and non saturable. There is very little risk of drug interactions due to protein-binding. The distribution volume is 91,8 to
104,6 litres.
After repeated administration there is no accumulation of zopiclone and its metabolites.
Individual variations appear to be low.
At recommended doses, the elimination half-life of the unchanged zopiclone is approximately 5 hours.
The low renal clearance value of unchanged zopiclone (mean 8,4 mL/min) compared with plasma clearance
(232 mL/min) indicates that zopiclone clearance is mainly metabolic. Zopiclone is eliminated by the urinary route
(approximately 80%) mainly in the form of free metabolites (N-oxide and N-demethyl derivatives) and in the faeces
(approximately 16%).
In elderly patients, notwithstanding a slight decrease in hepatic metabolism and lengthening of the elimination half-life
to approximately 7 hours, various studies have not shown plasma accumulation
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