Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

ZOPICLONE

NFPA

PRODUCT USE

Sedative/ hypnotic. Used in the short term management of insomnia. Taken by mouth. The
first of a family of non- benzodiazepines showing a pharmacological profile similar to
chlorodiazepoxide and nitrazepam. Adverse effects similar to those produced by
benzdiazepines are expected.

SYNONYMS

C17-H17-Cl-N6-O3, "1-piperazinecarboxylic acid, 4-methyl-, ", "1-piperazinecarboxylic
acid, 4-methyl-, ", "6-(5-chloro-2-pyridinyl)-6, 7-dihydro-7-oxo-5H-pyrralo[3, 4-
b]pyrazin-5-yl ester", "6-(5-chloro-2-pyridinyl)-6, 7-dihydro-7-oxo-5H-pyrralo[3, 4-
b]pyrazin-5-yl ester", "4-methyl-1-piperazinecarboxylic acid, ", "4-methyl-1-
piperazinecarboxylic acid, ", "6-(5-chloro-2-pyridinyl)-6, 7-dihydro-7-oxo-5H-pyrrolo[3,
4-b]pyrazin-5-yl ester", "6-(5-chloro-2-pyridinyl)-6, 7-dihydro-7-oxo-5H-pyrrolo[3, 4-
b]pyrazin-5-yl ester", "6-(5-chloropyrid-2-yl)-5-(4-methylpiperazin-1-yl)carbonyloxy-7-
oxo-6, 7-dihydro-5H-pyrrolo[3, 4-b]pyrazine", "6-(5-chloropyrid-2-yl)-5-(4-
methylpiperazin-1-yl)carbonyloxy-7-oxo-6, 7-dihydro-5H-pyrrolo[3, 4-b]pyrazine", "27267
R.P.", RP-27267, Amoban, Amovane, Imovane, Sopivan, Zimvane, Zopiclone, "Zoplicone,
racemic", "cyclopyrrolone/ non-benzodiazepine sedative/ hypnotic/ anxiolytic."

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Harmful if swallowed.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious damage to the health of the individual.  Benzodiazepine overdose is frequent, but serious poisonings are uncommon, sometimes even in high doses. The most common side-effects are drowsiness, dizziness and inco-  ordination. Higher doses cause more severe expression. Other effects may include low blood pressure, respiratory depression, nausea and constipation, changes in saliva output,  blurred and double vision, difficulty speaking, skin rashes, reduced urine output, incontinence, tremor and change in sex drive. Occasionally, there are blood changes and jaundice. Persons with a psychiatric history taking drugs should be monitored carefully as they are more prone to dependence and addiction. Side effects of sleeping medication include drowsiness, dizziness, light-headedness and inco-ordination and alcohol can increase them. Drug dependency can occur after a few weeks of nightly administration. Withdrawal of the drug is associated with a range of unpleasant effects and severity; it can also cause rebound insomnia, where the symptoms are worse than before. Rarely, behavior changes may follow administration of sleeping drugs. If used late in pregnancy it can sedate the fetus.  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may cause transient discomfort characterized by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. The material may produce foreign body irritation in certain individuals.  

SKIN

  Skin contact is not thought to produce harmful health effects (as classified using animal models). Systemic harm, however, has been identified following exposure of animals by at least one other route and the material may still produce health damage following entry through wounds, lesions or abrasions. Good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected.  

INHALED

  The material is not thought to produce either adverse health effects or irritation of the respiratory tract following inhalation (as classified using animal models). Nevertheless, adverse effects have been produced following exposure of animals by at least one other route and good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting.  

CHRONIC HEALTH EFFECTS

  Long term exposure to high dust concentrations may cause changes in lung function i.e. pneumoconiosis; caused by particles less than 0.5 micron penetrating and remaining in the lung. Prime symptom is breathlessness; lung shadows show on X-ray.  Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.  Based on experience with animal studies, there is a possibility that exposure to the material may result in toxic effects to the development of the fetus, at levels which do not cause significant toxic effects to the mother.  Prolonged use of benzodiazepines can lead to alcoholism-like dependence. Tolerance and withdrawal symptoms are seen in long-term treatment in high doses. Benzodiazepines can cause involuntary movements and difficulties in moving the muscles of the face. Arteriosclerosis, kidney, liver and respiratory conditions can be aggravated. They also cause an increased risk of some birth defects such as cleft palate. Benzodiazepines may be associated with some cancers.