ZOPICLONE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ZOPICLONE

Disponible des:

APOTEX INC

Codi ATC:

N05CF01

Designació comuna internacional (DCI):

ZOPICLONE

Dosis:

5MG

formulario farmacéutico:

TABLET

Composición:

ZOPICLONE 5MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Resumen del producto:

Active ingredient group (AIG) number: 0122562002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2013-03-04

Fitxa tècnica

PRODUCT MONOGRAPH
ZOPICLONE
ZOPICLONE
TABLETS, 5 MG AND 7.5 MG
HYPNOTIC AND SEDATIVE
APOTEX INC.
150 SIGNET DRIVE
WESTON, ONTARIO
DATE OF PREPARATION:
M9L 1T9
MARCH 11, 2013
CONTROL NUMBER: 162856
Page 2 of 49
PRODUCT MONOGRAPH
ZOPICLONE
Zopiclone
Tablets, 5 mg and 7.5 mg
THERAPEUTIC CLASSIFICATION
Hypnotic and Sedative
ACTIONS AND CLINICAL PHARMACOLOGY
Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic
agent. Zopiclone belongs to a
novel chemical class, which is structurally unrelated to existing
hypnotics. However, the
pharmacological profile of zopiclone is similar to that of the
benzodiazepines.
Zopiclone pharmacological properties are: hypnotic, sedative,
anxiolytic, anti-convulsant, 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.
In sleep laboratory studies of one to 21-day duration in man,
zopiclone reduced sleep latency,
increased the duration of sleep and decreased the number of nocturnal
awakenings. Zopiclone
delayed the onset of REM sleep but did not reduce consistently the
total duration of REM periods.
The duration of stage 1 sleep was shortened, and the time spent in
stage 2 sleep increased. In most
studies, stage 3 and 4 sleep tended to be increased, but no change and
actual decreases have also
Page 3 of 49
been observed. The effect of zopiclone on stage 3 and 4 sleep differs
from that of the
benzodiazepines which suppress slow wave sleep. The clinical
significance of this finding is not
known.
With hypnotic drugs, the duration of hypnotic effect and the profile
of unwanted effects may be
influenced by the alpha (distribution) (t½α) and beta (elimination)
(t½β) half-lives of the
administered drug and any active metabolites formed. When half-lives
are long, the drug or
metabolite may accumulate during periods of nightly administration and
be associated with
impairments of cognitive and motor performance during waking hours. If
half-lives