Back in August 2023 I posted about a new drug Zuranolone licensed by the FDA in USA to treat perinatal depression. The course lasts just 2 weeks but the manufacturer was recommending that mothers shouldn’t breastfeed on it or for a week after.
However, this afternoon (September 2023)I was listening to a webinar by Dr Tom Hale and Dr Kaytlin Krutsch where they presented data on 15 women who took it but pumped throughout.
“The manufacturer reports minimal transfer into breast milk. The concentration of drug-in-milk quantified in the milk was not disclosed; however, the mean RID was reported as 0.357% at day 5 (dose unknown; 30 to 50 mg per day). The oral bioavailability of zuranolone is unknown, but the reported RID% would likely result in negligible infant exposure.
Zuranolone has a dose-dependent abuse potential; patients report feeling euphoric mood, feeling drunk, and somnolence with zuranolone use. Adverse effects upon discontinuing the drug in the mother may include mild-to-moderate insomnia, palpitations, decreased appetite, paranoia, hyperhidrosis, nausea, and more. For the mother, there is a risk of excessive sedation with the potential inability of the mother to assess the degree of their impairment. This was not noticed in the lactation study. Instead, patients reported mild dizziness and potential memory loss during the treatment.[Poster: An open-label study to evaluate concentrations of zuranolone in the breastmilk of healthy lactating women. Available upon request to the manufacturer. Sage Therapeutics/BioGen Inc. 2021.]
Progesterone is thought to inhibit lactation. Researchers reported the average milk volume trended 8.3% down from a mean of 526 mL on day 1 to 485 mL on day 3 to 5 (when steady-state was reached). Moms were required to exclusively pump for the trial, which may partially explain the drop in volume.”
It is recommended that the baby so exposed through milk is monitored for sedation.
see also LactMed https://www.ncbi.nlm.nih.gov/books/NBK594292/
“Because of the low amounts of zuranolone in milk, it would not be expected to cause any adverse effects in breastfed infants. If zuranolone is required by the mother, it is not a reason to discontinue breastfeeding. Until more data are available, zuranolone should be used with careful infant monitoring for excessive sedation during breastfeeding, especially with higher dosages and in newborn and preterm infants.”
“The manufacturer reports a study in 14 healthy lactating women treated with oral administration of 30 mg of zuranolone daily for 5 days. The daily infant dose was approximately 0.0013 mg/kg, resulting in a mean weight-adjusted relative infant dose of 0.357% compared to the maternal dose. Concentrations of zuranolone in breastmilk were below the level of quantification limit by 4 to 6 days after the last dose.”
To my knowledge this drug is not yet approved in the UK.
- Mahase E US approves daily pill for postpartum depression https://www.bmj.com/content/382/bmj.p1822
- Perinatal depression: a neglected aspect of maternal health https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(23)01786-5.pdf
- Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, et al. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021;78(9):951–959.
- Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559. Erratum in: JAMA Psychiatry. 2022 Jul 1;79(7):740. Erratum in: JAMA Psychiatry. 2023 Feb 1;80(2):191. PMID: 34190962; PMCID: PMC8246337.
- An open-label study to evaluate concentrations of zuranolone in the breastmilk of healthy lactating women. Available upon request to the manufacturer. Sage Therapeutics/BioGen Inc. 2021