Lemborexant levels in maternal serum, cord blood, and breast milk during pregnancy and lactation: A case report

Saito, Jumpei; Ishii, Mariko; Sandaiji, Noriko; Yamaguchi, Koshi; Suzuki, Tomo; Yakuwa, Naho; Yamatani, Akimasa; Tachibana, Yukio; Sago, Haruhiko; Murashima, Atsuko

doi:10.1002/pcn5.62

Cited by 1 publication

(2 citation statements)

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“…The RID of 1.96% in this study is consistent with a separate case report where RID was 1.21% in breastmilk collected at 2-6 days postpartum from a woman who received LEM10 once daily from 12 weeks gestation. 14…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the sample size in this study was small ( n = 8 women). The RID of 1.96% in this study is consistent with a separate case report where RID was 1.21% in breastmilk collected at 2–6 days postpartum from a woman who received LEM10 once daily from 12 weeks gestation 14 . Further research is warranted to elucidate the safety and tolerability of LEM in infants breastfed by lactating women taking LEM, either with or without insomnia.…”

Section: Discussionmentioning

confidence: 99%

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Lemborexant levels in breast milk after single doses in healthy, lactating women

Rawal,

Brimhall,

Aluri

et al. 2023

Brit J Clinical Pharma

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AimTo determine the cumulative amount of lemborexant (a competitive dual orexin receptor antagonist approved to treat adults with insomnia) excreted in human breast milk, and the relative infant dose (RID) as a proportion of daily maternal dose.MethodsE2006‐A001‐010 was a single‐centre, open‐label study that enrolled lactating women (≥18 years) who breastfed for ≥5 weeks postpartum. After overnight fasting, subjects received a single 10‐mg oral dose of lemborexant. Using a standardised electric pump, milk was sampled before and ≤240 h (10 days) after dosing, then combined and total volume recorded. The cumulative total amount of lemborexant excreted, fraction of dose excreted, daily infant dose, and RID were calculated. Lemborexant concentration in human milk was assessed by liquid chromatography with tandem mass spectrometry.ResultsEight subjects completed the study. The mean cumulative total amount of lemborexant reached 0.0174 mg (coefficient of variation [CV] 54.5%; 0.174% of lemborexant 10 mg administered) in breast milk at 240 h (10 days); ~70% of excreted lemborexant accumulated in the first 24 h. For an infant weighing 6 kg, the daily infant dose was 0.00290 mg kg‐1 (CV 54.5%), and the RID was 1.96% (CV 63.1%) of daily maternal dose. Mild treatment‐emergent adverse events were reported in four subjects; these all resolved by end of study.ConclusionsTrace quantities of lemborexant were found in human breast milk. Lemborexant was well tolerated by healthy lactating women.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%