Summary of Use during Lactation

Oxazepam has low levels in breastmilk, a short half-life relative to many other benzodiazepines, and is administration directly to infants. Oxazepam would not be expected to cause any adverse effects in breastfed infants with usual maternal dosages. A safety scoring system finds oxazepam possible to use during breastfeeding.[1] Monitor the infant for sedation, poor feeding and poor weight gain.

Drug Levels

Oxazepam is a short-acting metabolite of diazepam.

Maternal Levels. In one mother who took oxazepam 15 to 30 mg daily, oxazepam concentration in breastmilk was about 10% that of the mother's serum from samples taken immediately before oxazepam doses and 4 hours later. The concentration of oxazepam in 12 breastmilk samples during the first 2 weeks postpartum varied between 11 and 26 mcg/L, whereas the concentration of conjugated oxazepam was less than 5 mcg/L in all samples.[2]

A mother who was 7 months postpartum was given oxazepam 10 mg orally 3 times daily for 3 days. Milk was collected twice daily in the morning and evening. After the first day, milk levels at the two times fluctuated little and ranged between 24 and 30 mcg/L. The half-life in milk after the last dose was about 12 hours.[3] At this dose, an exclusively breastfed infant would receive about 4 mcg of oxazepam daily or 0.7% of the maternal weight-adjusted dosage.

A woman who had been abusing benzodiazepines was taking diazepam 80 mg of diazepam and 30 mg of oxazepam daily at the time of study. 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 oxazepam milk levels were 30 and 22 mcg/L on days 14 and 14 during maternal intake of oxazepam 15 mg daily and diazepam 40 mg daily. The average of the pre- and post-feed oxazepam milk levels were 14 and 13 mcg/L on days 23 and 25 during maternal intake of diazepam 30 mg daily. Oxazepam is a metabolite of diazepam and probably contributed most of the oxazepam to the milk levels at this point.[4]

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

Effects in Breastfed Infants

A woman with major depression was treated with oxazepam and her breastfed infant was reportedly sedated. The dosage of oxazepam, age of the infant and extent of nursing were not reported.[5]

In a telephone follow-up study, 124 mothers who took a benzodiazepine while nursing reported whether their infants had any signs of sedation. Two mothers took oxazepam while breastfeeding and neither reported sedation in her infant.[6]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Lorazepam, Temazepam

References

1.

Uguz F. A new safety scoring system for the use of psychotropic drugs during lactation. Am J Ther 2021;28:e118-e126. [PubMed: 30601177]

2.

Rane A, Sundwall A, Tomson G. [Oxazepam withdrawal in the neonatal period]. Lakartidningen 1979;76:4416-7. [PubMed: 522574]

3.

Wretlind M. Excretion of oxazepam in breast milk. Eur J Clin Pharmacol 1987;33:209-10. [PubMed: 3691611]

4.

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. [PMC free article: PMC1380071] [PubMed: 2105100]

5.

Kemp J, Ilett KF, Booth J, et al. Excretion of doxepin and N-desmethyldoxepin in human milk. Br J Clin Pharmacol 1985;20:497-9. [PMC free article: PMC1400703] [PubMed: 4074620]

6.

Kelly LE, Poon S, Madadi P, et al. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr 2012;161:448-51. [PubMed: 22504099]

Substance Name

Oxazepam

CAS Registry Number

604-75-1

Drug Class

Breast Feeding

Lactation

Milk, Human

Hypnotics and Sedatives

Anti-Anxiety Agents

Benzodiazepines