The Basics

What is Temazepam?

Used on a short-term basis to treat insomnia.

Brand names for Temazepam

Restoril

How Temazepam is classified

Hypnotics and Sedatives, Anti-Anxiety Agents, Benzodiazepines

Temazepam During Pregnancy

Temazepam pregnancy category

Category XNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Temazepam while pregnant

Restoril is contraindicated in women who are or may become pregnant. If this drug is usedduring pregnancy, or if the patient becomes pregnant while taking this drug, the patient should beapprised of the potential hazard to the fetus. Patients should be instructed to discontinue the drugprior to becoming pregnant. The possibility that a woman of childbearing potential may bepregnant at the time of institution of therapy should be considered. Reproduction studies in animals with temazepam were performed in rats and rabbits. In aperinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nurslingmortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and120 mg/kg in one study and increased occurrence of rudimentary ribs, which are consideredskeletal variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasionalabnormalities such as exencephaly and fusion or asymmetry of ribs were reported without doserelationship. Although these abnormalities were not found in the concurrent control group, theyhave been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher,there was an increased incidence of the 13th rib variant when compared to the incidence inconcurrent and historical controls.

Taking Temazepam While Breastfeeding

What are recommendations for lactation if you're taking Temazepam?

Because of the low levels of temazepam in breastmilk and its relatively short half-life, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. Taking the bedtime dose after the infant’s last feeding of the day may minimize the dose received by an older infant who is sleeping through the night.

Maternal / infant drug levels

Because of the low levels of temazepam in breastmilk and its relatively short half-life, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. Taking the bedtime dose after the infant’s last feeding of the day may minimize the dose received by an older infant who is sleeping through the night.

Possible effects of Temazepam on milk supply

Relevant published information was not found as of the revision date..

Possible alternatives to Temazepam

Zaleplon, Zolpidem.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Dusci LJ, Good SM, Hall RW et al. Excretion of diazepam and its metabolites in human milk during withdrawal from combination high dose diazepam and oxazepam. Br J Clin Pharmacol. 1990;29:123-6. PMID: 2105100
2. Lebedevs TH, Wojnar-Horton RE, Yapp P et al. Excretion of temazepam in breast milk. Br J Clin Pharmacol. 1992;33:204-6. Letter. PMID: 1550703
3. Kelly LE, Poon S, Madadi P, Koren G. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 2012;161:448-51. PMID: 22504099

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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