Revised SPC: Zimovane (zopiclone) film-coated tablets
Due to reduced elimination, SPC advises a lower dose of 3.75 mg in hepatic dysfunction and contraindicates use in severe hepatic insufficiency due to risk of encephalopathy. Caution also advised in patients with depression with treatment for no longer than 4 weeks.
Source:
electronic Medicines compendium
SPS commentary:
SPC notes that complex sleep behaviours, including sleep walking and other associated behaviours, have been reported following the first or any subsequent use of zopiclone. Treatment should be discontinued immediately if a patient experiences a complex sleep behaviour, due to the risk to the patient and others. The use of alcohol and other CNS-depressants with zopiclone appears to increase the risk of such behaviours, as does the use of zopiclone at doses exceeding the maximum recommended dose.