DOM-ZOPICLONE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ZOPICLONE

Dostupné s:

DOMINION PHARMACAL

ATC kód:

N05CF01

INN (Mezinárodní Name):

ZOPICLONE

Dávkování:

5MG

Léková forma:

TABLET

Složení:

ZOPICLONE 5MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2002-07-30

Charakteristika produktu

PRODUCT MONOGRAPH
PR
DOM-ZOPICLONE
Zopiclone Tablets
5 mg and 7.5 mg
House Standard
HYPNOTIC AND SEDATIVE
DOMINION PHARMACAL
6111 Royalmount Ave, Suite #100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
May 7, 2019
Submission Control No.: 227095
_Dom-ZOPICLONE Product Monograph _
_Page 2 of 38 _
PRODUCT MONOGRAPH
Pr
Dom-ZOPICLONE
Zopiclone Tablets
5 mg and 7.5 mg
House Standard
Hypnotic and Sedative
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of zopiclone and opioids may result in profound
sedation, respiratory
depression, coma, and death (see WARNINGS, Risks from Concomitant use
of Opioids and
Benzodiazepines or Other CNS Depressants).

Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and
sedation.
ACTION AND CLINICAL PHARMACOLOGY
Dom-ZOPICLONE (zopiclone), a cyclopyrrolone derivative, is a
short-acting hypnotic agent.
Zopiclone 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 GABA
A
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