{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T05:19:07Z","timestamp":1787635147256,"version":"build-2736575974"},"reference-count":16,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T00:00:00Z","timestamp":1787529600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T00:00:00Z","timestamp":1787529600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>This paper aims to evaluate the plasma and breast milk pharmacokinetics of suvorexant, an orexin receptor antagonist used to treat insomnia at a maximum dose of 20\u2009mg, in healthy lactating women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The paper reports on an open\u2010label Phase 1 study in 12 healthy lactating women. Participants received a single oral dose of 20\u2010mg suvorexant following an overnight fast. Blood and breast milk samples for determination of suvorexant and its hydroxy suvorexant metabolite (M9) pharmacokinetics were collected up to 36\u2009h postdose. Participants were required to discontinue feeding their infants with breast milk from study intervention through 60\u2009h postdose to minimize the risk of exposure of suvorexant to an infant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Following a 20\u2010mg dose, suvorexant exposures in breast milk were markedly lower than plasma exposures (in terms of both area\u2010under\u2010the\u2010plasma concentration\u2010over\u2010time\u2010curve [AUC] and\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      ) as indicated by the breast milk to plasma ratio of 0.077 to 0.080. The mean amount of suvorexant recovered in breast milk by 36\u2009h was 0.011\u2009mg. Approximately 82% of the suvorexant that was excreted in breast milk was excreted by 24\u2009h. The mean estimated theoretical infant daily dose was 0.0016\u2009mg\/kg\/day, reflecting a relative infant dose of approximately 0.7% of the body weight normalized maternal dose.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Following a 20\u2010mg dose in healthy lactating women, suvorexant exposure in breast milk was markedly lower than plasma exposure. The mean estimated theoretical infant daily dose was less than 1% of the maternal dose.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70775","type":"journal-article","created":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T04:29:01Z","timestamp":1787632141000},"source":"Crossref","is-referenced-by-count":0,"title":["Plasma and breast milk pharmacokinetics of suvorexant in healthy lactating women"],"prefix":"10.1002","author":[{"given":"Jacqueline","family":"McCrea","sequence":"first","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Litovsky","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prachi","family":"Wickremasingha","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nairita","family":"Ghosal","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brad","family":"Roadcap","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Valesky","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Lee","sequence":"additional","affiliation":[{"name":"QPS Bio\u2010Kinetic Clinical Applications  Springfield Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leea D.","family":"Reed","sequence":"additional","affiliation":[{"name":"QPS Bio\u2010Kinetic Clinical Applications  Springfield Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming","family":"Wang","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Fang","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Wrishko","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,24]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2020.00161"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00737\u2010013\u20100356\u20109"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2019.09.026"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14538"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00679778"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102125.1990.tb03774.x"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/00912709922008308"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.2455"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15880"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev\u2010pharmtox\u2010010716\u2010104837"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.3109\/00498254.2015.1129565"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261\u2010018\u20100650\u20104"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261\u2010019\u201000764\u2010x"},{"key":"e_1_2_10_15_1","unstructured":"Food and Drug Administration.Clinical lactation studies: considerations for study design guidance for industry. 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