For the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings.
Non-benzodiazepine; Hypnotic
Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic agent. This 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 GABAA macromolecular complex, modulating the opening of the chloride ion channel.
ORAL Short-term management of insomnia: Adult: 7.5 mg at bedtime. Elderly: Initially, 3.75 mg at bedtime.
Zopiclone may produce more pronounced side effects when co- administered with:
Alcohol
Other tranquilizers or sleeping pills
Sedative antihistamines
Anticonvulsants (medicines used to control or prevent convulsions)
Narcotic analgesics (opioids)
Antipsychotics, antidepressants and other psychotropic medications (mood altering drugs) which themselves can make you sleepy.
Myasthenia gravis; resp failure; severe sleep apnoea syndrome; severe hepatic impairment; pregnancy, lactation. Hepatic & renal insufficiency; elderly; psychiatric disorders; history of drug abuse. May impair ability to drive or operate machinery. Limit treatment duration to <4 wk to minimise risk of dependence & tolerance. Avoid abrupt discontinuation of therapy.
Metallic or bitter aftertaste; irritability, confusion, depressed mood, aggressiveness, incoordination, anterog rade amnesia, mild increase in LFTs, drowsiness, lightheadedness, nausea, vomiting. urticaria, rashes.
Zopiclone crosses the placenta. Benzodiazepines may cause fetal damage when administered during pregnancy. During the first trimester of pregnancy, several studies have suggested an increased risk of congenital malformations associated with the use of benzodiazepines. zopiclone, in larger doses indicate that occasional use while breastfeeding an older infant should pose little risk to the infant, but the infant should be monitored for excessive drowsiness.
Overdose is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma according to the quantity ingested. In mild cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, symptoms may include ataxia, hypotonia, hypotension, methaemoglobinaemia, respiratory depression, and coma. Overdose should not be life threatening unless combined with other CNS depressants, including alcohol. Other risk factors, such as the presence of concomitant illness and the debilitated state of the patient, may contribute to the severity of symptoms and very rarely can result in fatal outcome. Symptomatic and supportive treatment in adequate clinical environment is recommended, attention should be paid to respiratory and cardiovascular functions. Gastric lavage or activated charcoal is only useful when performed soon after ingestion.
Store in a dry place, at room temperature (15°C to 30°C). Protect from light. Keep in a safe place out of reach of children.
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