{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T14:37:34Z","timestamp":1787668654262,"version":"build-2736575974"},"reference-count":14,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,8,23]],"date-time":"2023-08-23T00:00:00Z","timestamp":1692748800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004896","name":"Eisai Incorporated","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004896","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>The aim of this study is to 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>E2006\u2010A001\u2010010 was a single\u2010centre, open\u2010label study that enrolled lactating women (\u226518\u2009years) who breastfed for \u22655\u2009weeks postpartum. After overnight fasting, subjects received a single 10\u2010mg oral dose of lemborexant. Using a standardized electric pump, milk was sampled before and \u2264240\u2009h (10\u2009days) after dosing; combined and total volume were 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eight subjects completed the study. The mean cumulative total amount of lemborexant reached 0.0174\u2009mg (coefficient of variation [CV] 54.5%; 0.174% of lemborexant 10\u2009mg administered) in breast milk at 240\u2009h (10\u2009days); ~70% of excreted lemborexant accumulated in the first 24\u2009h. For an infant weighing 6\u2009kg, the daily infant dose was 0.00290\u2009mg\u2009kg<jats:sup>\u22121<\/jats:sup> (CV 54.5%) and the RID was 1.96% (CV 63.1%) of daily maternal dose. Mild treatment\u2010emergent adverse events were reported in 4 subjects; these all resolved by end of study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Trace quantities of lemborexant were found in human breast milk. Lemborexant was well tolerated by healthy lactating women.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.15880","type":"journal-article","created":{"date-parts":[[2023,8,10]],"date-time":"2023-08-10T10:08:34Z","timestamp":1691662114000},"page":"158-163","source":"Crossref","is-referenced-by-count":8,"title":["Lemborexant levels in breast milk after single doses in healthy, lactating women"],"prefix":"10.1111","volume":"90","author":[{"given":"Sumit","family":"Rawal","sequence":"first","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darin","family":"Brimhall","sequence":"additional","affiliation":[{"name":"PPD\u2010Thermo Fisher Scientific  Las Vegas Nevada USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jagadeesh","family":"Aluri","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jocelyn Y.","family":"Cheng","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Hall","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0807-2167","authenticated-orcid":false,"given":"Margaret","family":"Moline","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,8,23]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2019.09.026"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1089\/bfm.2022.0008"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00679778"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102125.1986.tb02903.x"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.817"},{"key":"e_1_2_12_7_1","unstructured":"Eisai Inc.DAYVIGO\u00ae (lemborexant) highlights of US prescribing information.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/212028s006lbl.pdf. Published 2021. Updated March 2022. Accessed January 16 2023."},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928\u2010020\u201009676\u20102"},{"key":"e_1_2_12_9_1","unstructured":"US Food and Drug Administration (FDA).Clinical lactation studies: considerations for study design. Guidance for Industry 2019.https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-lactation-studies-considerations-study-design. Accessed May 2 2023."},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.14748"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsaa123"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2019.18254"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2021.01.048"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14538"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/pcn5.62"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.15880","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,7]],"date-time":"2024-02-07T08:20:58Z","timestamp":1707294058000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1111\/bcp.15880"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,23]]},"references-count":14,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,1]]}},"alternative-id":["10.1111\/bcp.15880"],"URL":"https:\/\/doi.org\/10.1111\/bcp.15880","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,23]]}}}