<p>Benzodiazepines may cause fetal harm when administered to a&nbsp;pregnant&nbsp;woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first&nbsp;trimester&nbsp;of&nbsp;pregnancy&nbsp;has been suggested in several studies. Transplacental distribution has resulted in&nbsp;neonatal&nbsp;CNS depression following the ingestion of&nbsp;therapeutic&nbsp;doses of a benzodiazepine hypnotic during the last weeks of pregnancy.<br />
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Reproduction&nbsp;studies in animals with temazepam were performed in rats and rabbits. In a&nbsp;perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling&nbsp;mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered&nbsp;skeletal&nbsp;variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, there was an increased&nbsp;incidence&nbsp;of the 13th&nbsp;rib&nbsp;variant when compared to the incidence in concurrent and historical controls.<br />
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Temazepam is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the&nbsp;fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of&nbsp;therapy&nbsp;should be considered.</p>