Manifestations of acute overdosage of temazepam, as with other benzodiazepines, can be expected to reflect the increasing CNS effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes FDA Label L5539, F3718, F3721. With large overdoses, respiratory depression, hypotension, and finally coma can occur FDA Label L5539, F3718, F3721.

Benzodiazepines like temazepam might cause fetal harm when administered to a pregnant woman. Transplacental distribution has in the past resulted in neonatal CNS depression following the ingestion of therapeutic doses of related benzodiazepine hypnotics like diazepam during the last weeks of pregnancy FDA Label L5539, F3718, F3721.

It is not known whether this drug is excreted in human milk FDA Label L5539, F3718, F3721. Caution should, therefore, be exercised when temazepam is administered to a nursing woman FDA Label L5539, F3718, F3721.

Safety and effectiveness in pediatric patients have not been established FDA Label L5539, F3718, F3721.

Lower doses of temazepam, like 7.5 mg is recommended as the initial dosage for patients aged 65 and over since the risk of the development of oversedation, dizziness, confusion, ataxia and/or falls increases substantially with larger doses of benzodiazepines in elderly and debilitated patients FDA Label L5539, F3718, F3721.

No evidence of carcinogenicity was observed in animal studies although hyperplastic liver nodules were observed in female mice exposed to the highest doses of temazepam FDA Label L5539, F3718, F3721. The clinical significance of this finding is not known FDA Label L5539, F3718, F3721.

Fertility in male and female rats was not adversely affected by temazepam toxicity studies FDA Label L5539, F3718, F3721.

No mutagenicity tests have been done with temazepam FDA Label L5539, F3718, F3721.