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Diazepam (Valium®)

March 1, 2026

Selected References:

  • Aarskog D. 1975. Association between maternal intake of diazepam and oral clefts. Lancet. 2:921. 
  • Borgatta L, et al. 1997. Clinical significance of methohexital, meperidine, and diazepam in breast milk. J Clin Pharmacol. 37:186-92. 
  • Brandlistuen R, et al. 2017. Association of prenatal exposure to benzodiazepines and child internalizing problems: A sibling-controlled cohort study. PLoS One. 12(7):e0181042. 
  • Calderon-Margalit R, et al. 2009. Risk of preterm delivery and other adverse perinatal outcomes in relation to maternal use of psychotropic medications during pregnancy. Am J Obstet Gynecol. 201(6):579.e1-579.e1-8. 
  • Chen VC, et al. 2022. Association of prenatal exposure to benzodiazepines with development of autism spectrum and attention-deficit/hyperactivity disorders. JAMA Netw Open. 5(11): e2243282. 
  • Czeizel A. 1987. Lack of evidence of teratogenicity of benzodiazepine drugs in Hungary. Reprod Toxicol. 1(3):183-188. 
  • Czeizel A, et al. 1999. The effect of diazepam and promethazine treatment during pregnancy on the somatic development of human offspring. Neurotoxicol Teratol. 21(2):157-167. 
  • Diazepam drug label. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=167ee280-be68-4a28-a7d8-de41df14bc48&audience=consumer  
  • Engeland A, et al. 2013. Effects of preconceptional paternal drug exposure on birth outcomes: cohort study of 340 000 pregnancies using Norwegian population-based databases. Br J Clin Pharmacol. 75(4):1134-1141. 
  • Freeman MP, et al. 2018. Obstetrical and neonatal outcomes after benzodiazepine exposure during pregnancy: Results from a prospective registry of women with psychiatric disorders. Gen Hosp Psychiatry 53:73-79. 
  • Gilder ME, et al. 2021. Outcomes for 298 breastfed neonates whose mothers received ketamine and diazepam for postpartum tubal ligation in a resource-limited setting. BMC Pregnancy Childbirth. 21(1):121.  
  • Grigoriadis S, et al. 2020. Pregnancy and delivery outcomes following benzodiazepine exposure: a systematic review and meta-analysis. Can J Psychiatry. 65(12): 821-834. 
  • Iqbal MM, et al. 2002. Diazepam use during pregnancy: a review of the literature. Del Med J. 74(3):127-135. 
  • Jensen AG, et al, 2022. Prenatal exposure to benzodiazepines and the development of the offspring: a systematic review. Neurotoxicol Teratol. 91:107078. 
  • Jørgensen NP, et al. 1988. Pharmacokinetics and distribution of diazepam and oxazepam in early pregnancy. Acta Obstet Gynecol Scand. 67(6):493-497.  
  • Kjaer D, et al. 2007. Use of phenytoin, phenobarbital, or diazepam during pregnancy and risk of congenital abnormalities: a case-time-control study. Pharmacoepidemiol Drug Saf. 16(2):181-188. 
  • Laegreid L, et al. 1990. Congenital malformations and maternal consumption of benzodiazepines: a case-control study. Dev Med Child Neurol. 32(5):432-441. 
  • Laegreid L, et al. 1992. Neurodevelopment in late infancy after prenatal exposure to benzodiazepines–a prospective study. Neuropediatrics. 23(2):60-67. 
  • L, et al. 1992. The effect of benzodiazepines on the fetus and the newborn. Neuropediatrics. 23(1):18-23. 
  • Noh Y, et al. 2022. First-trimester exposure to benzodiazepines and risk of congenital malformations in offspring: A population-based cohort study in South Korea. PLoS Med. 19(3): e1003945. 
  • Ornoy A, et al. 1998. Is benzodiazepine use during pregnancy really teratogenic? Reprod Toxicol. 12(5):511-515. 
  • Rementeria J, Bhatt K. 1977. Withdrawal symptoms in neonates from intrauterine exposure to diazepam. J Pediatr. 90(1):123-126. 
  • Rosenberg L, et al. 1983. Lack of relation of oral clefts to diazepam use during pregnancy. N Engl J Med. 309(21):1282–1285. 
  • Safra M, Oakley GP. 1975. Association between cleft lip with or without cleft palate and prenatal exposure to diazepam. Lancet. 2(7933):478–480. 
  • Salisbury AL, et al. 2016. The Roles of Maternal Depression, Serotonin Reuptake Inhibitor Treatment, and Concomitant Benzodiazepine Use on Infant Neurobehavioral Functioning Over the First Postnatal Month. Am J Psychiatry. 173(2):147-157. 
  • Saxen I, Saxen L. 1975. Association between maternal intake of diazepam and oral clefts. Lancet. 2(7933):498. 
  • Shiono PH, Mills JL. 1984. Oral clefts and diazepam use during pregnancy. N Engl J Med. 311(14):919–920. 
  • Sundbakk LM, et al. 2022. Association of prenatal exposure to benzodiazepines and Z-hypnotics with risk of attention-deficit/hyperactivity disorder in childhood. JAMA Netw Open. 5(12): e2246889. 
  • 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. Depress Anxiety. 39(12):751-759. 
  • Uguz F. 2021. A new safety scoring system for the use of psychotropic drugs during lactation. Am J Ther 2021;28:e118–e126. 
  • Valium Drug label. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=554baee5-b171-4452-a50a-41a0946f956c&audience=consumer   
  • Wall-Wieler E, et al. 2020. Benzodiazepine use before conception and risk of ectopic pregnancy. Hum Reprod. 35(7):1685-1692. 
  • Wang X, et al. 2022. Prenatal exposure to benzodiazepines and Z-drugs in humans and risk of adverse neurodevelopmental outcomes in offspring: A systematic review. Neurosci Biobehav Rev. 137:10464. 
  • Wesson DR, et al. 1985. Diazepam and desmethyldiazepam in breast milk. J Psychoactive Drugs. 17(1):55-56. 
  • Wikner BN, et al. 2007. Use of benzodiazepines and benzodiazepine receptor agonists during pregnancy: neonatal outcome and congenital malformations. Pharmacoepidemiol Drug Saf. 16(11):1203-1210. 
  • Yonkers KA, et al. 2017. Association of panic disorder, generalized anxiety disorder, and benzodiazepine treatment during pregnancy with risk of adverse birth outcomes. JAMA Psychiatry. 74(11):1145-1152. 

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