Q-ZOPICLONE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ZOPICLONE

Dostępny od:

QD PHARMACEUTICALS ULC

Kod ATC:

N05CF01

INN (International Nazwa):

ZOPICLONE

Dawkowanie:

7.5MG

Forma farmaceutyczna:

TABLET

Skład:

ZOPICLONE 7.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0122562001; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2015-08-21

Charakterystyka produktu

1
PRODUCT MONOGRAPH
Pr
Q-ZOPICLONE
ZOPICLONE TABLETS 5.0 MG AND 7.5 MG TABLETS
Hypnotic and Sedative
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
Canada, M8Z 2S6
Submission Control No.: 184021
Date of Revision:
May 12, 2015
2
NAME OF DRUG
PR
Q-ZOPICLONE
Zopiclone Tablets
5.0 mg and 7.5 mg Tablets
Hypnotic and Sedative
ACTIONS, CLINICAL PHARMACOLOGY
Q-ZOPICLONE (zopiclone), a cyclopyrrolone derivative, is a
short-acting hypnotic agent.
Q-ZOPICLONE is structurally unrelated to existing hypnotics. However,
the
pharmacological profile of Q-ZOPICLONE is similar to that of the
benzodiazepines.
Q-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 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 are
short, the drug and