Last update Nov. 2, 2022

Zolpidem Tartrate

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Imidazopyridine with benzodiazepine-like hypnotic effect. Used for insomnia. Oral administration once a day, usually at night before bedtime.

It is excreted in breast milk in clinically insignificant amounts. (Saito 2022 & 2022, Pons 1994 &1989) 

No problems have been observed in infants whose mothers were taking it. (Saito 2022 apr)

Plasma levels of Zolpidem were not detected in these infants. (Saito 2022 oct)

Five nursing mothers who took twice the usual dose, excreted it into breast milk in a clinically non-significant amount, maximum at 3 hours and undetectable from 4-5 hours post-dose. (Hale, Chen 2010, Pons 1989)

Several experts consider the use of this medication safe or probably safe during breastfeeding (Hale, Briggs 2017), although known data are limited. (Uguz 2021)

American Academy of Pediatrics: medication usually compatible with breastfeeding. (AAP 2001).

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 this 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.)

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

Zolpidem Tartrate in other languages or writings:

Group

Zolpidem Tartrate belongs to this group or family:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 70 %
Molecular weight 765 daltons
Protein Binding 93 %
VD 0.54 l/Kg
pKa 6.2 -
Tmax 0.75 - 2.6 hours
1.4 - 4.8 hours
M/P ratio 0.1 - 0.2 -
Theoretical Dose 0.004 mg/Kg/d
Relative Dose 0.004 - 2.4 %

References

  1. Saito J, Tachibana Y, Kawasaki H, Tamon H, Ishii M, Wada YS, Oho M, Yakuwa N, Suzuki T, Sago H, Yamatani A, Murashima A. Transfer of Zolpidem to Cord Blood and Breast Milk: A Case Series Evaluating Zolpidem Serum Levels and Outcomes in Birth and Suckling Infants. Breastfeed Med. 2022 Oct 26. Consulted on Nov. 2, 2022 Abstract
  2. Saito J, Tachibana Y, Sano Wada Y, Kawasaki H, Miura Y, Oho M, Aoyagi K, Yakuwa N, Suzuki T, Yamatani A, Sago H, Murashima A. Presence of Hypnotics in the Cord Blood and Breast Milk, with No Adverse Effects in the Infant: A Case Report. Breastfeed Med. 2022 Apr;17(4):349-352. Consulted on April 11, 2022 Abstract
  3. 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)
  4. 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
  5. (ABM): Blair PS, Ball HL, McKenna JJ, Feldman-Winter L, Marinelli KA, Bartick MC; Academy of Breastfeeding Medicine.. Bedsharing and Breastfeeding: The Academy of Breastfeeding Medicine Protocol #6, Revision 2019. Breastfeed Med. 2020 Jan;15(1):5-16. Abstract Full text (link to original source) Full text (in our servers)
  6. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  7. 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)
  8. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  9. 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)
  10. 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)
  11. 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)
  12. Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Breastfeeding travelers: precautions and recommendations. J Travel Med. 2010 Jan-Feb;17(1):32-47. Abstract Full text (link to original source) Full text (in our servers)
  13. 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)
  14. FDA- Zolpidem. Drug Summary. 2008 Full text (in our servers)
  15. 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)
  16. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  17. Drover DR. Comparative pharmacokinetics and pharmacodynamics of short-acting hypnosedatives: zaleplon, zolpidem and zopiclone. Clin Pharmacokinet. 2004 Abstract
  18. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  19. AEMPS-Ratiopharm. Zolpidem. Ficha técnica. 2001 Full text (in our servers)
  20. Salvà P, Costa J. Clinical pharmacokinetics and pharmacodynamics of zolpidem. Therapeutic implications. Clin Pharmacokinet. 1995 Abstract
  21. Pons G, Rey E, Matheson I. Excretion of psychoactive drugs into breast milk. Pharmacokinetic principles and recommendations. Clin Pharmacokinet. 1994 Abstract
  22. Pons G, Francoual C, Guillet P, Moran C, Hermann P, Bianchetti G, Thiercelin JF, Thenot JP, Olive G. Zolpidem excretion in breast milk. Eur J Clin Pharmacol. 1989 Abstract

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