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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="citation_inbook_title" content="Drugs and Lactation Database (LactMed®) [Internet]" /><meta name="citation_title" content="Lemborexant" /><meta name="citation_publisher" content="National Institute of Child Health and Human Development" /><meta name="citation_date" content="2024/09/15" /><meta name="citation_pmid" content="33104322" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK563399/" /><meta name="citation_keywords" content="Lemborexant" /><meta name="citation_keywords" content="Dayvigo" /><meta name="citation_keywords" content="E 2006" /><meta name="citation_keywords" content="(1R,2S)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Lemborexant" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="National Institute of Child Health and Human Development" /><meta name="DC.Date" content="2024/09/15" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK563399/" /><meta name="description" content="Amounts of lemborexant in milk appear to be low. If lemborexant is required by the mother, it is not a reason to discontinue breastfeeding. However, until more data become available, monitor the infant for sedation, especially while nursing a newborn or preterm infant." /><meta name="og:title" content="Lemborexant" /><meta name="og:type" content="book" /><meta name="og:description" content="Amounts of lemborexant in milk appear to be low. If lemborexant is required by the mother, it is not a reason to discontinue breastfeeding. However, until more data become available, monitor the infant for sedation, especially while nursing a newborn or preterm infant." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK563399/" /><meta name="og:site_name" content="NCBI Bookshelf" /><meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-lactmed-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/lactmed/lemborexant/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK563399/" /><link rel="stylesheet" href="/corehtml/pmc/css/figpopup.css" type="text/css" media="screen" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_print.min.css" type="text/css" /><style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} </style><script type="text/javascript" src="/corehtml/pmc/js/jquery.hoverIntent.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/common.min.js?_=3.18"> </script><script type="text/javascript">window.name="mainwindow";</script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/book-toc.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/books.min.js"> </script>
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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. </p></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK563399_"><span class="title" itemprop="name">Lemborexant</span></h1><p class="small">Last Revision: <span itemprop="dateModified">September 15, 2024</span>.</p><p><em>Estimated reading time: 2 minutes</em></p></div><div class="body-content whole_rhythm" itemprop="text"><p>CASRN: 1369764-02-2</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/392977269" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=392977269" alt="image 392977269 in the ncbi pubchem database" /></a><div id="lemborexant.Drug_Levels_and_Effects"><h2 id="_lemborexant_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="lemborexant.Summary_of_Use_during_Lactat"><h3>Summary of Use during Lactation</h3><p>Amounts of lemborexant in milk appear to be low. If lemborexant is required by the mother, it is not a reason to discontinue breastfeeding. However, until more data become available, monitor the infant for sedation, especially while nursing a newborn or preterm infant.</p></div><div id="lemborexant.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> A woman took lemborexant 10 mg, brotizolam 0.25 mg and etizolam 0.5 mg at bedtime during pregnancy and postpartum. Five colostrum samples were taken during day 2 and 3 postpartum at times ranging from 8 to 19.6 hours after a dose. Milk concentrations ranged from 1.8 to 12.7 mcg/L, with the highest concentration in the sample taken 8 hours after the dose. The estimated daily infant dose via breastmilk using the highest milk level value was 1.91 mcg/kg daily, which translates to a relative infant dose of 1.21%.[<a class="bk_pop" href="#lemborexant.REF.1">1</a>]</p><p>A manufacturer-sponsored study was done in 8 women who had breastfed for at least 5 weeks postpartum. Each was given a single 10 mg oral dose of lemborexant and complete extractions of breastmilk were collected by an electric breast pump in intervals up to 10 days after the dose. Over the 240-hour collection period a total of 0.0174 mg of the unchanged drug was collected in milk, 70% of which was from the first 24 hours of collection. The authors calculated that a fully breastfed infant would receive an average weight-adjusted relative infant dose of 1.96% of the mother’s dose.[<a class="bk_pop" href="#lemborexant.REF.2">2</a>]</p><p>In a study describing a new assay method, milk samples were donated by a woman with bipolar disorder who was on long-term lemborexant therapy at a dose of 5 mg every night before sleep. Milk samples were collected “a few days” after delivery at 70 and 565 minutes after a dose. The concentrations in breastmilk were 4.69 mcg/L at 70 minutes and 5.12 mcg/L at 565 minutes after administration. The authors estimated a relative infant dose of 1.05% at 565 minutes after administration.[<a class="bk_pop" href="#lemborexant.REF.3">3</a>]</p><p><i>Infant Levels.</i> Relevant published information was not found as of the revision date.</p></div><div id="lemborexant.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="lemborexant.Effects_on_Lactation_and_Bre"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="lemborexant.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p><a href="/books/n/lactmed/LM395/">Zaleplon</a>, <a href="/books/n/lactmed/LM396/">Zolpidem</a></p></div><div id="lemborexant.References"><h3>References</h3><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="lemborexant.REF.1">Saito
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J, Ishii
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M, Sandaiji
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N, et al.
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Lemborexant levels in maternal serum, cord blood, and breast milk during pregnancy and lactation: A case report.
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Psychiatry Clin Neurosci Rep
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2023;2:e62. doi:10.1002/pcn5.62
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[<a href="/pmc/articles/PMC11114320/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC11114320</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/38868416" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38868416</span></a>] [<a href="http://dx.crossref.org/10.1002/pcn5.62" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd><dt>2.</dt><dd><div class="bk_ref" id="lemborexant.REF.2">Rawal
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S, Brimhall
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D, Aluri
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J, et al.
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Lemborexant levels in breast milk after single doses in healthy, lactating women.
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Br J Clin Pharmacol
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2024;90:158-63.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/37565541" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37565541</span></a>]</div></dd><dt>3.</dt><dd><div class="bk_ref" id="lemborexant.REF.3">Ishikawa
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H, Furugen
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A, Nishimura
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A, et al.
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Validated UPLC-MS/MS method for quantification of melatonin receptor agonists and dual orexin receptor antagonists in human plasma and breast milk: Application to quantify suvorexant and lemborexant in clinical samples.
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J Pharm Biomed Anal
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2024;251:116432.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/39180895" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39180895</span></a>]</div></dd></dl></div></div><div id="lemborexant.Substance_Identification"><h2 id="_lemborexant_Substance_Identification_">Substance Identification</h2><div id="lemborexant.Substance_Name"><h3>Substance Name</h3><p>Lemborexant</p></div><div id="lemborexant.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>1369764-02-2</p></div><div id="lemborexant.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Hypnotics and Sedatives</p><p>Orexin Receptor Antagonists</p><p>Sleep Aids, Pharmaceutical</p></div></div><div><dl class="temp-labeled-list small"><dt></dt><dd><div><p class="no_top_margin"><p><b>Disclaimer: </b>Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.</p></p></div></dd></dl></div><div id="bk_toc_contnr"></div></div></div>
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<div class="post-content"><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a><p class="small"><b>Attribution Statement:</b> LactMed is a registered trademark of the U.S. Department of Health and Human Services.</p></div><div class="small"><span class="label">Bookshelf ID: NBK563399</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/33104322" title="PubMed record of this page" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">33104322</a></span></div><div style="margin-top:2em" class="bk_noprnt"><a class="bk_cntns" href="/books/n/lactmed/">Contents</a><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/lactmed/LM1066/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/lactmed/LM926/" title="Next page in this title">Next ></a></div></div></div></div>
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