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Are Hypnotic Benzodiazepine Receptor Agonists Teratogenic in Humans?

Wikner, Birgitta Norstedt and Källén, Bengt LU (2011) In Journal of Clinical Psychopharmacology 31. p.356-359
Abstract
BACKGROUND:: Hypnotic benzodiazepine receptor agonists (HBRAs; zolpidem, zopiclone, and zaleplon) are used in the treatment of insomnia. Little is known about the safety of HBRAs during pregnancy. METHODS:: Data from the Swedish Medical Birth Registry from July 1, 1995, up to 2007 were used to identify 1318 women who reported the use of HBRAs in early pregnancy. They gave birth to 1341 infants. Maternal characteristics and the presence of congenital malformations were compared with all other women who gave birth (n = 1,106,001) and all other infants (n = 1,125,734) born during the study period. RESULTS:: Use and/or reporting of HBRAs increased with maternal age and were higher at first than higher parity. Maternal smoking was strongly... (More)
BACKGROUND:: Hypnotic benzodiazepine receptor agonists (HBRAs; zolpidem, zopiclone, and zaleplon) are used in the treatment of insomnia. Little is known about the safety of HBRAs during pregnancy. METHODS:: Data from the Swedish Medical Birth Registry from July 1, 1995, up to 2007 were used to identify 1318 women who reported the use of HBRAs in early pregnancy. They gave birth to 1341 infants. Maternal characteristics and the presence of congenital malformations were compared with all other women who gave birth (n = 1,106,001) and all other infants (n = 1,125,734) born during the study period. RESULTS:: Use and/or reporting of HBRAs increased with maternal age and were higher at first than higher parity. Maternal smoking was strongly associated with reported use of HBRAs. The probability of using HBRAs increased in women who had had 3 or more earlier miscarriages or 5 or more years of involuntary childlessness. An excess use of other drugs and above all psychoactive drugs were seen in women reporting use of HBRAs.Hypnotic benzodiazepine receptor agonists were not associated with an increased risk for congenital malformations. A statistically significant high risk for other intestinal malformations than atresias/stenosis was based on only 4 infants. CONCLUSIONS:: Maternal use of HBRAs does not seem to increase malformation risk. The tentative association with some intestinal malformations may be due to chance because of multiple testing and needs confirmation. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Clinical Psychopharmacology
volume
31
pages
356 - 359
publisher
Lippincott Williams & Wilkins
external identifiers
  • WOS:000290033100016
  • PMID:21508851
  • Scopus:79955597670
ISSN
0271-0749
DOI
10.1097/JCP.0b013e3182197055
language
English
LU publication?
yes
id
6c011c97-3cc2-433b-ab58-8e0b74e499f1 (old id 1936856)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/21508851?dopt=Abstract
date added to LUP
2011-05-02 15:20:25
date last changed
2017-02-22 10:46:53
@article{6c011c97-3cc2-433b-ab58-8e0b74e499f1,
  abstract     = {BACKGROUND:: Hypnotic benzodiazepine receptor agonists (HBRAs; zolpidem, zopiclone, and zaleplon) are used in the treatment of insomnia. Little is known about the safety of HBRAs during pregnancy. METHODS:: Data from the Swedish Medical Birth Registry from July 1, 1995, up to 2007 were used to identify 1318 women who reported the use of HBRAs in early pregnancy. They gave birth to 1341 infants. Maternal characteristics and the presence of congenital malformations were compared with all other women who gave birth (n = 1,106,001) and all other infants (n = 1,125,734) born during the study period. RESULTS:: Use and/or reporting of HBRAs increased with maternal age and were higher at first than higher parity. Maternal smoking was strongly associated with reported use of HBRAs. The probability of using HBRAs increased in women who had had 3 or more earlier miscarriages or 5 or more years of involuntary childlessness. An excess use of other drugs and above all psychoactive drugs were seen in women reporting use of HBRAs.Hypnotic benzodiazepine receptor agonists were not associated with an increased risk for congenital malformations. A statistically significant high risk for other intestinal malformations than atresias/stenosis was based on only 4 infants. CONCLUSIONS:: Maternal use of HBRAs does not seem to increase malformation risk. The tentative association with some intestinal malformations may be due to chance because of multiple testing and needs confirmation.},
  author       = {Wikner, Birgitta Norstedt and Källén, Bengt},
  issn         = {0271-0749},
  language     = {eng},
  pages        = {356--359},
  publisher    = {Lippincott Williams & Wilkins},
  series       = {Journal of Clinical Psychopharmacology},
  title        = {Are Hypnotic Benzodiazepine Receptor Agonists Teratogenic in Humans?},
  url          = {http://dx.doi.org/10.1097/JCP.0b013e3182197055},
  volume       = {31},
  year         = {2011},
}