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Temazepam (Restoril®)

January 1, 2025

Selected References:  

  • Ban L, et al. 2014. First trimester exposure to anxiolytic and hypnotic drugs and the risks of major congenital anomalies: a United Kingdom population-based cohort study. PLoS One; 9(6):e100996. 
  • Dusci LJ, et al. 1990. Excretion of diazepam and its metabolites in human milk during withdrawal from combination high dose diazepam and oxazepam. Br J Clin Pharmacol; 29:123-6.  
  • Kanto JH. 1982. Use of benzodiazepines during pregnancy, labour and lactation, with particular reference to pharmacokinetic considerations. Drugs 23:354-80.  
  • Kargas GA, et al. 1985. Perinatal mortality due to interaction of diphenhydramine and temazepam. N Eng J Med 313:1417-8. 
  • Kelly LE, et al. Neonatal benzodiazepines exposure during breastfeeding. J Pediatr. 161:448-51. 
  • Lebedevs TH, et al. 1992. Excretion of temazepam in breast milk. Br J Clin Pharmacol; 33:204-6. 
  • Restoril Prescribing Information. Available online at www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf. [Accessed May 2025]. 
  • Sheehy O, et al. 2019. Association between incident exposure to benzodiazepines in early pregnancy and risk of spontaneous abortion. JAMA psychiatry, 76(9): 948-57.
  • Szpunar MJ, et al. 2022. Risk of major malformations in infants after first‐trimester exposure to benzodiazepines: Results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. Depression and Anxiety 39.12: 751-9. 

 

 

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