Sign Out
Use in Pregnancy: 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.
Insufficient data are available on zopiclone to assess its safety during human pregnancy. Thus the use of APO-ZOPICLONE (zopiclone) during pregnancy is not recommended. If APO-ZOPICLONE is prescribed to woman of child-bearing potential, the patient should be warned of the potential risk to a fetus and advised to consult the physician regarding the discontinuation of the drug if the patient intends to become pregnant or suspects that the patient is pregnant.
During the last weeks of pregnancy, ingestion of therapeutic doses of a benzodiazepine hypnotic has resulted in neonatal CNS depression due transplacental distribution. Similar effects can be expected to occur with zopiclone, due to its pharmacological effects.
For teratogenic effects (see Warnings). Non teratogenic effects: a child born to mother who is on benzodiazepines or benzodiazepine-like agents may be at risk for withdrawal symptoms from the drug during the postnatal period.
Use in Nursing Mothers: Zopiclone is excreted in human milk, and its concentration may reach 50% of the plasma levels. Therefore, the administration of APO-ZOPICLONE to nursing mothers is not recommended.
