Zopiclone

Indications
 Oral
Short-term management of insomnia
Adult: 7.5 mg at bedtime.
Elderly: Initially, 3.75 mg at bedtime.
Renal impairment: Initiate at 3.75 mg at bedtime.
Hepatic impairment: Mild to moderate: Initially 3.75 mg at bedtime. Severe: Contraindicated.

Special Populations: Severe hepatic insufficiency: 3.75 mg at night.
Contraindications
 Myasthenia gravis; respiratory failure; severe sleep apnoea syndrome; severe hepatic impairment; pregnancy, lactation.
Warnings / Precautions
 Hepatic and 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 and tolerance. Avoid abrupt discontinuation of therapy.
Adverse Reactions
 Metallic or bitter aftertaste; irritability, confusion, depressed mood, aggressiveness, incoordination, anterograde amnesia, mild increase in LFTs, drowsiness, lightheadedness, nausea, vomiting, urticaria, rashes.
Overdose Reactions
 Symptoms: CNS depression ranging from drowsiness to coma depending on ingested amount. In mild cases, there may be drowsiness, confusion, and lethargy while in more serious cases, there may be ataxia, hypotonia, hypotension, respiratory depression and coma. Management: Treatment is symptomatic and supportive with close monitoring of the respiratory and CV functions. Gastric lavage is only of value if performed within 1 hr after ingestion. Haemodialysis is unlikely to be useful. Flumazenil may be a useful antidote in severe CNS depression.
Drug Interactions
 Reduced hypnotic effect with phenytoin and carbamazepine. Increased drowsiness and incoordination with TCAs. Increased CNS depressant effect with alcohol and other CNS depressants. Decreased zopiclone concentration with rifampicin. Possible increase in zopiclone concentration with CYP3A4 inhibitors e.g. erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir.
See Below for More zopiclone Drug Interactions
Food Interactions
 Possible decrease in zopiclone levels with St John's Wort.
Mechanism of Actions
 Zopiclone is a cyclopyrrolone derivative with hypnotic and sedative actions, anticonvulsant and muscle relaxant properties similar to benzodiazepines. It binds to a site in the GABA-A-benzodiazepine-chloride channel macromolecular-receptor complex which is different from that of the benzodiazepine binding site.
Absorption: Rapidly absorbed from the GI tract (oral).
Distribution: Widely distributed. Enters breast milk. Protein-binding: 45-80%.
Metabolism: Extensively hepatic; converted to less active N-oxide and inactive N-desmethylzopiclone. Undergoes decarboxylation to inactive metabolites.
Excretion: Urine, faeces (as unchanged drug and metabolites), lungs and saliva; 3.5-6.5 hr (elimination half-life).
Administration
 May be taken with or without food.
Storage Conditions
 Oral: Store in a dry place below 30°C. Protect from light.
ATC Classification
 N05CF01 - zopiclone ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Storage
 Oral: Store in a dry place below 30°C. Protect from light.
Available As
  • Zopiclone 3.75 mg
  • Zopiclone 7.5 mg

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