Zaleplon

Although animal studies have shown no teratogenic or embryotoxic effects, insufficient clinical data are available on zaleplon to assess its safety during pregnancy. Use of zaleplon is not recommended during pregnancy. If the medicinal product is prescribed to a woman of child-bearing potential, she should be warned to contact her physician regarding discontinuance of the medicinal product if she intends to become or suspects that she is pregnant.

If for compelling medical reasons, the medicinal product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.

Infants born to mothers who took benzodiazepine and benzodiazepine-like agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.

Although animal studies have shown no teratogenic or embryotoxic effects, insufficient clinical data are available on zaleplon to assess its safety during breastfeeding.

Because zaleplon is excreted in the breast milk, it should not be administered to breast-feeding mothers.

Zaleplon has major influence on the ability to drive and use machines.

Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines the next day. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Furthermore, the co-administration of zaleplon with alcohol and other CNS depressants increases this risk. Caution is recommended for patients performing skilled tasks. Patients should be advised not to drive or operate machinery until it is established that their performance is not impaired.