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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="Nitrazepam" /><meta name="citation_publisher" content="National Institute of Child Health and Human Development" /><meta name="citation_date" content="2024/01/15" /><meta name="citation_pmid" content="29999709" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK500650/" /><meta name="citation_keywords" content="nitrazepam" /><meta name="citation_keywords" content="Benzalin" /><meta name="citation_keywords" content="Neozepam" /><meta name="citation_keywords" content="Mogadon" /><meta name="citation_keywords" content="Imeson" /><meta name="citation_keywords" content="Remnos" /><meta name="citation_keywords" content="Neuchlonic" /><meta name="citation_keywords" content="Eunoctin" /><meta name="citation_keywords" content="Nitrados" /><meta name="citation_keywords" content="Radedorm" /><meta name="citation_keywords" content="Trazenin" /><meta name="citation_keywords" content="Apodorm" /><meta name="citation_keywords" content="Calsmin" /><meta name="citation_keywords" content="Imesont" /><meta name="citation_keywords" content="Sonebon" /><meta name="citation_keywords" content="Hipnax" /><meta name="citation_keywords" content="Hipsal" /><meta name="citation_keywords" content="Nelmat" /><meta name="citation_keywords" content="Surem" /><meta name="citation_keywords" content="Epibenzalin" /><meta name="citation_keywords" content="Epinelbon" /><meta name="citation_keywords" content="Nitrenpax" /><meta name="citation_keywords" content="Unisomnia" /><meta name="citation_keywords" content="Dormicum" /><meta name="citation_keywords" content="Somitran" /><meta name="citation_keywords" content="Sonnolin" /><meta name="citation_keywords" content="Dumolid" /><meta name="citation_keywords" content="Paxisyn" /><meta name="citation_keywords" content="Cerson" /><meta name="citation_keywords" content="Nelbon" /><meta name="citation_keywords" content="Pelson" /><meta name="citation_keywords" content="Relact" /><meta name="citation_keywords" content="Persopit" /><meta name="citation_keywords" content="Ibrovek" /><meta name="citation_keywords" content="Gerson" /><meta name="citation_keywords" content="Nitrazepamum" /><meta name="citation_keywords" content="Atempol" /><meta name="citation_keywords" content="Mitidin" /><meta name="citation_keywords" content="Dormo-Puren" /><meta name="citation_keywords" content="Dormin-5" /><meta name="citation_keywords" content="N-Desmethylnimetazepam" /><meta name="citation_keywords" content="Eatan N" /><meta name="citation_keywords" content="Nitrazepamum [INN-Latin]" /><meta name="citation_keywords" content="Dormicum (anticonvulsant)" /><meta name="citation_keywords" content="LA 1" /><meta name="citation_keywords" content="146-22-5" /><meta name="citation_keywords" content="LA 1 (VAN)" /><meta name="citation_keywords" content="UNII-9CLV70W7HS" /><meta name="citation_keywords" content="Ro 4-5360" /><meta name="citation_keywords" content="Ro 5-3059" /><meta name="citation_keywords" content="9CLV70W7HS" /><meta name="citation_keywords" content="CCRIS 1931" /><meta name="citation_keywords" content="NSC-58775" /><meta name="citation_keywords" content="1,3-Dihydro-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one" /><meta name="citation_keywords" content="DEA No. 2834" /><meta name="citation_keywords" content="EINECS 205-665-2" /><meta name="citation_keywords" content="NSC 58775" /><meta name="citation_keywords" content="7-Nitro-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-2-one" /><meta name="citation_keywords" content="S 2000" /><meta name="citation_keywords" content="BRN 0757185" /><meta name="citation_keywords" content="7-Nitro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one" /><meta name="citation_keywords" content="2,3-Dihydro-7-nitro-5-phenyl-1H-1,4-benzodiazepin-2-on" /><meta name="citation_keywords" content="2H-1,4-Benzodiazepin-2-one, 1,3-dihydro-7-nitro-5-phenyl-" /><meta name="citation_keywords" content="5-24-04-00344" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Nitrazepam" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="National Institute of Child Health and Human Development" /><meta name="DC.Date" content="2024/01/15" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK500650/" /><meta name="description" content="Nitrazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration. It is excreted into breastmilk in small amounts. Because of its long half-life of about 30 hours, it may accumulate in the serum of breastfed infants with repeated doses. Other agents are preferred, especially while nursing a newborn or preterm infant. If nitrazepam is used, monitor the infant for sedation, poor feeding and poor weight gain." /><meta name="og:title" content="Nitrazepam" /><meta name="og:type" content="book" /><meta name="og:description" content="Nitrazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration. It is excreted into breastmilk in small amounts. Because of its long half-life of about 30 hours, it may accumulate in the serum of breastfed infants with repeated doses. Other agents are preferred, especially while nursing a newborn or preterm infant. 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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="_NBK500650_"><span class="title" itemprop="name">Nitrazepam</span></h1><p class="small">Last Revision: <span itemprop="dateModified">January 15, 2024</span>.</p><p><em>Estimated reading time: 2 minutes</em></p></div><div class="body-content whole_rhythm" itemprop="text"><p>CASRN: 146-22-5</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/134974781" 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=134974781" alt="image 134974781 in the ncbi pubchem database" /></a><div id="LM1086.Drug_Levels_and_Effects"><h2 id="_LM1086_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM1086.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Nitrazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration. It is excreted into breastmilk in small amounts. Because of its long half-life of about 30 hours, it may accumulate in the serum of breastfed infants with repeated doses. Other agents are preferred, especially while nursing a newborn or preterm infant. If nitrazepam is used, monitor the infant for sedation, poor feeding and poor weight gain.</p></div><div id="LM1086.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> Five women received radioactively tagged nitrazepam 5 mg at 8 pm daily for 5 days. Milk samples were collected daily at 9 am and 5:45 pm. The authors estimated that an infant would receive about 5 to 10 mcg/L of nitrazepam per 100 mL of milk ingested.[<a class="bk_pop" href="#LM1086.REF.1">1</a>]</p><p>Ten mothers were given oral nitrazepam 5 mg for sleep in the first 5 nights postpartum if they requested it. One of the mothers did not produce enough milk to measure the drug. Of the remaining 9 mothers, between 4 and 8 took the medication nightly. Milk nitrazepam levels were measured at 6 am the following day, 6 to 8 hours after the previous dose. Average milk concentrations were about 8.4 mcg/L on day 1 and 14 mcg/L on day 5. The authors calculated that a breastfed infant would receive an average of between 1 and 1.5 mcg per 100 mL of milk ingested or a maximum of 2 mcg per 100 mL.[<a class="bk_pop" href="#LM1086.REF.2">2</a>] This is equivalent to about 2.6% of the maternal weight-adjusted dose.[<a class="bk_pop" href="#LM1086.REF.3">3</a>]</p><p><i>Infant Levels.</i> One mother took nitrazepam 5 mg orally at bedtime for sleep nightly for 5 nights while breastfeeding her newborn. On day 5 of life, nitrazepam was undetectable (<2.8 mcg/L) in the infant's serum.[<a class="bk_pop" href="#LM1086.REF.2">2</a>]</p></div><div id="LM1086.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="LM1086.Effects_on_Lactation_and_Breastmi"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM1086.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p>(Anxiety) <a href="/books/n/lactmed/LM364/">Lorazepam</a>, <a href="/books/n/lactmed/LM377/">Oxazepam</a>, Temazepam (Seizure Disorder) <a href="/books/n/lactmed/LM400/">Carbamazepine</a>, <a href="/books/n/lactmed/LM437/">Divalproex</a>, <a href="/books/n/lactmed/LM358/">Gabapentin</a>, <a href="/books/n/lactmed/LM399/">Lamotrigine</a>, <a href="/books/n/lactmed/LM376/">Oxcarbazepine</a>, <a href="/books/n/lactmed/LM402/">Phenytoin</a>, <a href="/books/n/lactmed/LM403/">Valproic Acid</a> (Oral for Sleep) <a href="/books/n/lactmed/LM395/">Zaleplon</a>, <a href="/books/n/lactmed/LM396/">Zolpidem</a></p></div><div id="LM1086.References"><h3>References</h3><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="LM1086.REF.1">Rieder J, Wendt G. Pharmacokinetics and metabolism of the hypnotic nitrazepam. In: Garattini S ME, Randall LO, ed. The benzodiazepines. New York: Raven Press; 1973:99-127.</div></dd><dt>2.</dt><dd><div class="bk_ref" id="LM1086.REF.2">Matheson
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I, Lunde
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PKM, Bredesen
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JE. Midazolam and nitrazepam in the maternity ward: Milk concentrations and clinical effects.
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Br J Clin Pharmacol
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1990;30:787-93.
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[<a href="/pmc/articles/PMC1368298/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC1368298</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/2288825" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2288825</span></a>]</div></dd><dt>3.</dt><dd><div class="bk_ref" id="LM1086.REF.3">Hägg
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S, Spigset
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O. Anticonvulsant use during lactation.
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Drug Saf
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2000;22:425-40.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/10877037" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10877037</span></a>]</div></dd></dl></div></div><div id="LM1086.Substance_Identification"><h2 id="_LM1086_Substance_Identification_">Substance Identification</h2><div id="LM1086.Substance_Name"><h3>Substance Name</h3><p>Nitrazepam</p></div><div id="LM1086.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>146-22-5</p></div><div id="LM1086.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Hypnotics and Sedatives</p><p>Anti-Anxiety Agents</p><p>Benzodiazepines</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: NBK500650</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/29999709" title="PubMed record of this page" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">29999709</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/nitisinone/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/lactmed/LM201/" title="Next page in this title">Next ></a></div></div></div></div>
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