Temazepam use while Breastfeeding

Drugs containing Temazepam: Restoril

Temazepam Levels and Effects while Breastfeeding

Summary of Use during Lactation

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.

Drug Levels

Maternal Levels. A woman who had been abusing benzodiazepines was taking diazepam 80 mg of diazepam as well as oxazepam. Temazepam is a metabolite of diazepam. Milk samples were taken before and after the morning feeding following the morning dose of diazepam during a 30-day tapering dosage regimen. The average of the pre- and post-feed temazepam milk levels were 13 and 18 mcg/L on days 14 and 15 during maternal intake of diazepam 40 mg daily. The average of the pre- and post-feed temazepam milk levels were 13 and 14 mcg/L on days 23 and 25 during maternal intake of diazepam 30 mg daily.[2]

Ten women who were less than 15 days postpartum were given temazepam 10 or 20 mg (0.16 to 0.32 mg/kg) at bedtime once daily for at least 2 days prior to being studied. Milk samples were taken immediately before and after a feeding that ranged from 10.3 to 21.3 hours after the dose. Milk temazepam levels were undetectable (<5 mcg/L) in 9 of the 10 women. In the tenth who had a plasma temazepam of 234 mcg/L (several times higher than the other women), milk temazepam levels were 28 and 26 mcg/L before and after a feed that occurred 14.1 hours after the previous dose of temazepam. Oxazepam, a metabolite of temazepam, was undetectable (<5 mcg/L) in all of the subjects' milk samples.[3]

Infant Levels. Two breastfed infants had undetectable (<5 mcg/L) plasma levels of temazepam or its metabolite oxazepam 13.3 and 14.8 hours after maternal doses of temazepam 0.16 and 0.17 mg/kg orally.[3]

Effects in Breastfed Infants

Ten infants who less than 15 days old were breastfed by mothers who had taken temazepam 10 or 20 mg (0.16 to 0.32 mg/kg) at bedtime once daily for at least 2 days. None of the infants had any observable adverse reactions.[2]

In a telephone follow-up study, 124 mothers who took a benzodiazepine while nursing reported whether their infants had any signs of sedation. One mother took temazepam while breastfeeding and reported no sedation in her infant.[3]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Zaleplon, Zolpidem

References

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

Temazepam Identification

Substance Name

Temazepam

CAS Registry Number

846-50-4

Drug Class

Hypnotics and Sedatives

Anti-Anxiety Agents

Benzodiazepines

Administrative Information

LactMed Record Number

388

Last Revision Date

20130907

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