Last update June 24, 2022

Zaleplon

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Zaleplon is a pyrazolopyrimidine with sedative properties similar to benzodiazepines. It is used as a hypnotic in the treatment of insomnia Oral administration at bedtime.

It is excreted in non-significant clinical amount into breast milk. (Darwish 1999)

Foods with high fat content (e.g, breast milk) delay absorption by the gut. Its low oral bioavailability decreases the pass of it from the mother's milk to the infant's plasma, except in prematures or in the early neonatal period, when a higher intestinal absorption may occur.

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable (Uguz 2021), especially during the neonatal period and in the event of prematurity.

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)

It has been withdrawn from the market in several countries.

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.)
  • Zopiclone ( 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

Zaleplon in other languages or writings:

Group

Zaleplon belongs to this group or family:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 30 %
Molecular weight 305 daltons
Protein Binding 60 %
VD 1.4 - 4 l/Kg
Tmax 1.4 hours
1 hours
M/P ratio 0.5 -
Theoretical Dose 0.002 mg/Kg/d
Relative Dose 1.2 %
Ped.Relat.Dose 1.5 %

References

  1. 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
  2. (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)
  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. 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)
  7. 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)
  8. 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)
  9. 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)
  10. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  11. FDA. Zaleplon. Drug Summary. 2005 Full text (in our servers)
  12. Drover DR. Comparative pharmacokinetics and pharmacodynamics of short-acting hypnosedatives: zaleplon, zolpidem and zopiclone. Clin Pharmacokinet. 2004 Abstract
  13. 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)
  14. OMS. Comité de Expertos de la OMS en Farmacodependencia. Examen crítico de psicofármacos. OMS. Serie de informes técnicos, 33 informe. 2003 Full text (in our servers)
  15. Osakidetza. Zaleplon. Ficha técnica. 2001 Full text (in our servers)
  16. Darwish M, Martin PT, Cevallos WH, Tse S, Wheeler S, Troy SM. Rapid disappearance of zaleplon from breast milk after oral administration to lactating women. J Clin Pharmacol. 1999 Abstract

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