Last update May 19, 2022

Daridorexant

Low Risk

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

Daridorexant is a dual orexin receptor antagonist used to treat insomnia in adults. Oral administration in one dose at bedtime.

At the date of the last update we did not find any published data on its excretion in breast milk.

Its pharmacokinetic characteristics (very high plasma protein binding, moderately elevated molecular weight and large volume of distribution) make it very unlikely its excretion into breast milk in significant amounts.

Infants exposed to this drug through breast milk should be monitored for excessive sedation and/or poor feeding. (FDA 2022)

It is not recommended to share a bed with the baby if this drug is being taken(UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006)

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

Alternatives

  • Lorazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Oxazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Zaleplon (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • 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

Daridorexant in other languages or writings:

  • C23H23ClN6O2 (Molecular formula)
  • N05CM?? (ATC Code/s)

Group

Daridorexant belongs to this group or family:

Tradenames

Main tradenames from several countries containing Daridorexant in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 62 %
Molecular weight 451 daltons
Protein Binding 99.7 %
VD 0.44 l/Kg
pKa 11.8 -
Tmax 1 - 2 hours
8 hours

References

  1. FDA. Daridorexant (QUVIVIQ). Drug Summary. 2022 Consulted on May 19, 2022 Full text (in our servers)
  2. EMA. Daridorexant (QUVIVIQ). Drug Summary. 2022 Consulted on May 18, 2022 Full text (in our servers)
  3. EMA. Daridorexant (QUVIVIQ). Ficha técnica. 2022 Consulted on May 18, 2022 Full text (in our servers)
  4. UNICEF UK. Caring for your baby at night. A guide for parents. 2018 Full text (link to original source) Full text (in our servers)
  5. 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)
  6. 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)
  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. 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)
  9. 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)
  10. 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)
  11. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)

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