Last update June 25, 2022

Zopiclone

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Cyclopyrrolone with sedative effects, anxiolytic, amnesic, anticonvulsant and relaxing similar to those of benzodiazepines muscle. Used as a hypnotic for insomnia. Oral administration in one dose shortly before bedtime. Eszopiclone, the (+)-isomer of zopiclone, is used similarly.

It is excreted in breast milk in clinically non-significant amount. (Mathieu 2010, Matheson 1990, Gaillot 1983 & 1982)

No problems have been observed in infants whose mothers have taken it. (Mathieu 2010, Matheson 1990) 

Expert authors consider the use of this medication possible during lactation. (Hale, Uguz 2021)

It can produce dependence and withdrawal symptoms if stopped abruptly. (WHO 2003)

It is recommended to check for sedation and/or lack of appetite in infants. Bed-sharing (co-sleeping) with the baby is not recommended if thos drug are used(ABM 2020 y 2008, UNICEF 2018, 2017, 2014 y 2013, Landa 2012, UNICEF 2006)

Alternatives

  • Lorazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Oxazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Zolpidem Tartrate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Zopiclone in other languages or writings:

Group

Zopiclone belongs to this group or family:

Tradenames

Main tradenames from several countries containing Zopiclone in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 75 %
Molecular weight 389 daltons
Protein Binding 45 %
VD 1.3 - 1.4 l/Kg
pKa 8.04 -
Tmax 1.5 - 2 hours
5 (3.8 - 6.5) hours
M/P ratio 0.5 - 0.8 -
Theoretical Dose 0.001 - 0.002 mg/Kg/d
Relative Dose 0.54 - 1.3 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Abstract
  3. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  4. UNICEF. Ball H, Blair PS. (For UNICEF UK). Caring for your baby at night. Health professional´s guide. 2017 Full text (link to original source) Full text (in our servers)
  5. UNICEF UK. Statement on co-sleeping following publication of new NICE postnatal guidance. Infosheet. 2014 Full text (link to original source) Full text (in our servers)
  6. Sanofi. Zopiclone. Drug Summary. 2014 Full text (in our servers)
  7. UNICEF UK Baby Friendly Initiative statement on Bed-sharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case-control studies. None 2013 Full text (link to original source) Full text (in our servers)
  8. AEMPS. Zopiclona. Ficha técnica 2013 Full text (in our servers)
  9. L.Landa Rivera, M.Díaz-Gómez, A.Gómez Papi, J.M.Paricio Talayero, C.Pallás Alonso, M.T.Hernández Aguilar, J.Aguayo Maldonado, J.M.Arena Ansotegui, S.Ares Segura, A.Jiménez Moya, J.J.Lasarte Velillas, J.Martín Calama, M.D.Romero Escós. El colecho favorece la práctica de la lactancia materna y no aumenta el riesgo de muerte súbita del lactante. Dormir con los padres. Rev Pediatr Aten Primaria. 14:53-60 2012 Full text (link to original source) Full text (in our servers)
  10. Mathieu O, Masson F, Thompson MA, Leplay M, Mazurier E, Hillaire-Buys D. (Abstracts of the 14th Annual Meeting of French Society of Pharmacology and Therapeutics, 77th Annual Meeting of Society of Physiology, 31th Pharmacovigilance Meeting, 11th APNET Seminar and 8th CHU CIC Meeting, 23-25 March 2010, Bordeaux, France). Case report: in utero exposure and safe breastfeeding in two premature twins of a chronically treated mother with high doses of zopiclone. Fundam Clin Pharmacol 2010;24 (Suppl. S1), 88. abst424. doi:10.1111/j.1472-8206.2010.00819.x
  11. ABM - Comité de protocolos de la Academia médica de lactancia materna (Academy of Breastfeeding Medicine). Protocolo Clínico de la ABM #6: Lineamientos sobre la práctica de dormir al bebé junto con la madre y la lactancia materna Revisión, marzo de 2008. Breastfeeding Medicine 2008 Full text (link to original source) Full text (in our servers)
  12. ABM - The Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #6: Guideline on Co-Sleeping and Breastfeeding. Breastfeeding Medicine 2008 Abstract Full text (link to original source) Full text (in our servers)
  13. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  14. Drover DR. Comparative pharmacokinetics and pharmacodynamics of short-acting hypnosedatives: zaleplon, zolpidem and zopiclone. Clin Pharmacokinet. 2004 Abstract
  15. WHO Expert Committee on Drug Dependence. Critical review of psychoactive substances. WHO Technical Report Series. Thirty-third Report 2003 Full text (link to original source) Full text (in our servers)
  16. Matheson I, Sande HA, Gaillot J. The excretion of zopiclone into breast milk. Br J Clin Pharmacol. 1990 Abstract
  17. Gaillot J, Heusse D, Hougton GW, Marc Aurele J, Dreyfus JF. Pharmacokinetics and metabolism of zopiclone. Pharmacology. 1983 Abstract
  18. Gaillot J, Heusse D, Hougton GW, Marc Aurele J, Dreyfus JF. Pharmacokinetics and metabolism of zopiclone. Int Pharmacopsychiatry. 1982 Abstract

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