Apo-Zopiclone

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Zopiclone 7.5mg

Available from:

Apotex NZ Ltd

INN (International Name):

Zopiclone 7.5 mg

Dosage:

7.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Zopiclone 7.5mg Excipient: Brilliant blue FCF Carnauba wax Hypromellose Lactose monohydrate Macrogol 3350 Magnesium stearate Microcrystalline cellulose Purified water Quinoline yellow Titanium dioxide

Units in package:

Blister pack, PVC/PVDC/Al and PVC/PE/PVDC/Al, 30 tablets

Class:

Prescription

Prescription type:

Class C5 Controlled Drug

Manufactured by:

Centaur Pharmaceuticals Private Limited

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al and PVC/PE/PVDC/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 500 tablets - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1997-10-21

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-ZOPICLONE
Zopiclone 7.5mg Tablets
Please refer to Medsafe website (
www.medsafe.govt.nz
) for the most recent datasheet
Page 1
PRESENTATION
Apo-Zopiclone 7.5mg tablets are blue, oval, biconvex, film coated tablets, scored and engraved APO7.5
on one side. Each tablet contains 7.5mg zopiclone and typically weighs 165mg.
USES
ACTIONS
Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic that belongs to a novel chemical class
which is structurally unrelated to existing hypnotics. However, its pharmacological profile is similar to that
of the benzodiazepines.
Its pharmacological properties are hypnotic, sedative, anixolytic, anti-convulsant and 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, 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
although these results were variable. Zopiclone does not suppress slow wave sleep during stages 3 and 4
sleep. Negligible residual effects are seen the following morning. Rebound insomnia after cessation of
treatment is not usually a feature. Dependence potential appears to be less pronounced with zopiclone
than with benzodiazepines.
PHARMACOKINETICS
Zopiclone is rapidly and well absorbed after oral administration. Bioavailablity is more than 75%, although
an hepatic first-pass effect has been demonstrated. It is widely dis