Zopiclone is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

Zopiclone is a cyclopyrrolone derivative and a short-acting hypnotic agent. It is structurally unrelated to existing hypnotics; however, its pharmacological profile is similar to benzodiazepines. Zopiclone exhibits hypnotic, sedative, anxiolytic, anticonvulsant, and muscle-relaxant properties. These effects are mediated through a specific agonist action at central receptors belonging to the GABA macromolecular complex, which modulates the opening of chloride ion channels.

The recommended initial dose is 3.75 mg (one-half of a 7.5 mg tablet). The dose can be increased to 5 mg and further to 7.5 mg if clinically indicated. In some patients, the higher doses result in zopiclone blood levels in the morning high enough to produce impairment of driving and other activities that require full alertness. The 7.5 mg dose should not be exceeded.

Treatment with Zopiclone should usually not exceed 7-10 consecutive days. Use for more than 2-3 consecutive weeks requires complete re-evaluation of the patient. Prescriptions for Zopiclone should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply. The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime functioning.

Zopiclone may produce more pronounced side effects when used with:

• Alcohol
• Other tranquilizers or sleeping pills
• Sedative antihistamines
• Anticonvulsants (used to control or prevent convulsions)
• Narcotic analgesics (opioids)
• Antipsychotics, antidepressants, and other psychotropic medicines (mood-altering drugs) that themselves may cause drowsiness

Zopiclone is contraindicated in patients with severe hepatic insufficiency. It is also contraindicated in patients with severe respiratory impairment.

Common side effects include somnolence, dizziness, confusion, anterograde amnesia or memory impairment, feeling of drunkenness, euphoria, nightmares, agitation, anxiety, nervousness, hostility, depression, decreased libido, coordination abnormality, headache, hypotonia, tremor, muscle spasms, paresthesia, speech disorder, palpitations, bitter taste (dysgeusia), dry mouth, coated tongue, bad breath, nausea, vomiting, diarrhea, constipation, anorexia, or increased appetite.

Do not take Zopiclone at any time during pregnancy as it may harm the developing baby. It passes into breast milk; therefore, it should be avoided during breastfeeding. Consult your doctor before use.

• Do not take more Zopiclone than prescribed.
• Do not use for longer than recommended due to risk of dependence.
• Avoid alcohol during treatment.
• Inform your doctor if you have a history of sleepwalking.
• Inform your doctor if you have sleep disorders such as Periodic Limb Movement Disorder or Restless Legs Syndrome.

Zopiclone is not indicated for patients under 18 years of age.

Overdose may cause CNS depression ranging from drowsiness to coma. Mild symptoms include drowsiness, confusion, and lethargy. Severe symptoms include ataxia, hypotonia, hypotension, methaemoglobinaemia, respiratory depression, and coma. It is usually not life-threatening unless combined with alcohol or other CNS depressants. Treatment is symptomatic and supportive with attention to respiratory and cardiovascular function. Gastric lavage or activated charcoal is useful only if given soon after ingestion.

Miscellaneous sedatives & hypnotics

Store in a dry place at room temperature (15°C to 30°C). Protect from light. Keep out of reach of children.