Information last updated: June 2020
The baseline risk of major birth defects in Canada is 3-5%. This means that 3-5 out of 100 babies born in the general population in Canada will be born with a major birth defect. There are also baseline risks for miscarriages (15-25 out of 100 pregnancies), prematurity and other outcomes. The information provided will summarize if taking this drug is likely to change these risks.
Please consult with your health care provider if you are considering stopping or making any changes to your regular medications.
This information about zopiclone is of a general nature and about medical use and does not replace the medical care and advice of your healthcare provider. For questions on dose, timing, side effects, interactions, etc. please consult your healthcare provider. Additionally, please read the patient insert provided with your medication. If you are using zopiclone or other drugs or medications for non-medical reasons or beyond what was recommended by a healthcare provider, please see Harm Reduction section. In case of emergency, please go to the emergency room or call 911.
Although participants in the studies referenced below may have used zopiclone in various combinations, the studies usually do not provide detailed information on drug combinations. This makes it challenging to comment on the safety of using this medication in combination with others during pregnancy or lactation.Pronunciation
Over 1500 pregnancies with exposure to zopiclone in the first trimester of pregnancy were included in published studies. Based on these studies, it is not expected that taking zopiclone in pregnancy will increase the risk of babies being born with major birth defects above the baseline risk.
In one small study, exposure to zopiclone in pregnancy did not increase the risk of miscarriage above the baseline risk. More information is needed before a conclusion can be made on the risk of miscarriage with use of zopiclone in pregnancy.
Zopiclone when used not as prescribed (in higher doses, more often, or for longer period than prescribed) has potential for dependence and problematic (non-medical) use because it can produce euphoria (a strong feeling of well-being, happiness, or excitement).
There have been no studies looking at problematic, non-medical use of zopiclone in pregnancy.
Medications, if not taken as prescribed, if taken beyond the prescribed amount, or if taken in combination with certain other drugs, may cause harm to you and/or your pregnancy or your nursing child.
If you are using zopiclone or other drugs or medications for non-medical reasons or beyond what was recommended by a healthcare practitioner and you are pregnant, providing your breastmilk to an infant, or parenting please click here Harm Reduction for additional information. In case of emergency, please go to the emergency room or call 911.
Using drugs beyond what your clinician prescribes during pregnancy or parenting in a way that harms you or your baby may result in a community member or care provider contacting child protective services.
Pregnancy:
Over 1500 pregnancies with exposure to zopiclone in the first trimester of pregnancy were included in published studies. Based on the available data, the use of zopiclone during pregnancy is not expected to increase the risk of major birth defects above the baseline risk.
In one small study, exposure to zopiclone in pregnancy did not increase the risk of miscarriage above the baseline risk. More information is needed before a conclusion can be made on the risk of miscarriage with use of zopiclone in pregnancy.
While one study found an increased risk of prematurity, low birth weight and small for gestational age when hypnotic benzodiazepine receptor agonists (HBRAs) were used in the 2nd or 3rd trimester of pregnancy, the risk, if real, is anticipated to be small and has not been confirmed in other studies. These results need to be interpreted with caution as they may be confounded by the indication for treatment, the characteristics of the exposed individuals and exposures to other medications. No data specific to zopiclone was provided.
There have been some reports of newborns having withdrawal-like symptoms (e.g., breathing issues, low blood sugar) when zopiclone or other HBRAs were used in pregnancy, mostly when use was close to delivery. These results may have been confounded by other medication exposures, and characteristics of the exposed individuals. It is recommended to monitor the newborn for such symptoms if zopiclone is used in late pregnancy.
Lactation:
Please check back. We are in the process of reviewing if there is available information on the effects of taking trazodone during lactation.
Harm Reduction:
If your patient may be using zopiclone or other drugs or medications not as indicated during pregnancy, while providing breastmilk to an infant, or parenting please click here Harm Reduction for additional information. In case of emergency, please advise them to go to the emergency room or call 911.
For additional resources see
Ban L, West J, Gibson JE, Fiaschi L, Sokal R, Doyle P, et al. First trimester exposure to anxiolytic and hypnotic drugs and the risks of major congenital anomalies: a United Kingdom population-based cohort study. PLoS ONE. 2014;9(6):e100996.[PMID: 24963627].
Canadian Centre on Substance Use and Addiction. Sedatives – Canadian Drug Summary. [Internet]. Ottawa:Canadian Centre on Substance Use and Addiction; 2024 [updated 2022 May; cited 2024 January 24]. Available from https://www.ccsa.ca/sites/default/files/2022-06/CCSA-Canadian-Drug-Summary-Sedatives-2022-en_0.pdf
Diav-Citrin O, Okotore B, Lucarelli K, Koren G. Pregnancy outcome following first-trimester exposure to zopiclone: a prospective controlled cohort study. Am J Perinatol. 1999;16(4):157-60.[PMID: 10458526].
Huybrechts KF, Bateman BT, Desai RJ, Hernandez-Diaz S, Rough K, Mogun H, et al. Risk of neonatal drug withdrawal after intrauterine co-exposure to opioids and psychotropic medications: cohort study. BMJ. 2017;358:j3326.[PMID: 28768628].
Kallen B, Borg N, Reis M. The use of central nervous system active drugs during pregnancy. Pharmaceuticals (Basel). 2013;6(10):1221-86.[PMID: 24275849].
Mathieu O, Masson F, Thompson MA, Leplay M, Mazurier E, Hillaire-Buysa D. Case report: in utero exposure and safe breastfeeding in two premature twins of a chronically treated mother with high doses of zopiclone. Fundamental & Clinical Pharmacology. 2010;24:Abstract 424.
Public Health Agency of Canada. Congenital Anomalies in Canada 2013: A Perinatal Health Surveillance Report. [Internet]. Ottawa: Public Health Agency of Canada; 2013 [updated 2013 September; cited 2023 September 8]. Available from: https://publications.gc.ca/collections/collection_2014/aspc-phac/HP35-40-2013-eng.pdf
Public Health Agency of Canada. Family-centred maternity and newborn care: National guidelines Chapter 7: Loss and grief. [Internet]. Ottawa: Public Health Agency of Canada; 2022 [updated 2022 Aug 10; cited 2023 September 9]. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/maternity-newborn-care-guidelines-chapter-7.html
Sanofi-aventis Canada Inc. Imovane (Zopiclone) Product Monograph Laval, QC: Sanofi-Aventis Canada Inc.; 2018 [revised 2018 September 27; cited 2023 December 20]. Available from: https://pdf.hres.ca/dpd_pm/00047597.PDF
Stephens S, Wilson G, Gilfillan C, McElhatton PR, Thomas SHL. Preliminary data on therapeutic exposure to zopiclone during pregnancy. Reproductive Toxicology. 2008;26(1):73-4.[conference abstract 36th Annual Conference of the European Teratology Society].
Wikner BN, Stiller CO, Bergman U, Asker C, Kallen B. Use of benzodiazepines and benzodiazepine receptor agonists during pregnancy: neonatal outcome and congenital malformations. Pharmacoepidemiol Drug Saf. 2007;16(11):1203-10.[PMID: 17894421].
Wikner BN, Kallen B. Are hypnotic benzodiazepine receptor agonists teratogenic in humans? J Clin Psychopharmacol. 2011;31(3):356-9.[PMID: 21508851]
First Exposure does not offer health care treatment. If you have an urgent question about your pregnancy or your baby’s health, you should contact your health care provider directly. If you don’t have a health care provider and you live in Ontario, you have a variety of health care options. In the case of an emergency, visit a hospital emergency room or call 911.
