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match">&#9664;</a><button id="jr-fip-matches">no matches yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">&#9654;</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK548556_"><span class="title" itemprop="name">Temazepam</span></h1><p class="fm-aai"><a href="#_NBK548556_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Temazepam.OVERVIEW"><h2 id="_Temazepam_OVERVIEW_">OVERVIEW</h2><div id="Temazepam.Introduction"><h3>Introduction</h3><p>Temazepam is an orally available benzodiazepine used in the therapy of insomnia. As with most benzodiazepines, temazepam has not been associated with serum aminotransferase or alkaline phosphatase elevations during therapy, and clinically apparent liver injury from temazepam has not been reported and must be very rare, if it occurs at all.</p></div><div id="Temazepam.Background"><h3>Background</h3><p>Temazepam (tem az' e pam) is a benzodiazepine that is used as a sleeping aid in the therapy of insomnia. The soporific activity of the benzodiazepines is mediated by their ability to enhance gamma-aminobutyric acid (GABA) mediated inhibition of synaptic transmission through binding to the GABA A receptor. Temazepam was approved in the United States in 1981 and is still widely used with more than 2 million prescriptions written yearly. Current indications are limited to the short term treatment of insomnia. Temazepam is available in capsules of 7.5, 15, 22.5 and 30 mg in several generic forms and under the brand name Restoril. The recommended initial dose for insomnia is 7.5 mg before bedtime, increasing as needed to a maximum dose of 30 mg. The most common side effects of temazepam are dose related and include daytime drowsiness, lethargy, ataxia, dysarthria and dizziness. Tolerance develops to these side effects, but tolerance may also develop to the effects on insomnia. Rare but severe adverse events include hallucinations, restlessness, agitation, and hypersensitivity reactions including angioedema. Temazepam like all oral benzodiazepines has a boxed warning in its product label stressing the risks of severe sedation and potentially fatal respiratory depression when combined with opiates, the risks of abuse, misuse, and addiction with prolonged use which can lead to overdose and death, and the risks of dependence with continued use and severe potentially life-threatening withdrawal symptoms if discontinued suddenly.</p></div><div id="Temazepam.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>Temazepam, like other benzodiazepines, is rarely associated with serum ALT elevations, and clinically apparent liver injury from temazepam is extremely rare, if it occurs at all. There have been no case reports of symptomatic, acute liver injury from temazepam. Isolated single cases of clinically apparent liver injury have been reported with other benzodiazepines including alprazolam, chlordiazepoxide, clonazepam, diazepam, flurazepam, lorazepam, and triazolam. The clinical pattern of acute liver injury from benzodiazepines is typically cholestatic and mild-to-moderate in severity with a latency of 1 to 6 months and rapid resolution with discontinuation. Fever and rash are uncommon as is autoantibody formation.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p></div><div id="Temazepam.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>Temazepam is metabolized by the liver to inactive metabolites. Liver injury from benzodiazepines is probably due to the toxic effects of a rarely produced intermediate metabolite.</p></div><div id="Temazepam.Outcome_and_Management"><h3>Outcome and Management</h3><p>The case reports of hepatic injury due to benzodiazepines were followed by prompt and complete recovery upon stopping the medication, without evidence of residual or chronic injury. No cases of acute liver failure or chronic liver injury due to temazepam have been described. There is no information about cross reactivity with other benzodiazepines, but some degree of cross sensitivity may occur.</p><p>Drug Class: <a href="/books/n/livertox/Sedatives_Hypnotics/?report=reader">Sedatives and Hypnotics</a>, <a href="/books/n/livertox/BenzodiazepineDrugs/?report=reader">Benzodiazepines</a></p></div></div><div id="Temazepam.PRODUCT_INFORMATION"><h2 id="_Temazepam_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
<b>REPRESENTATIVE TRADE NAMES</b>
</p><p>Temazepam &#x02013; Generic, Restoril&#x000ae;</p><p>
<b>DRUG CLASS</b>
</p><p>Sedatives and Hypnotics</p><p>
<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&#x00026;query=temazepam" ref="pagearea=body&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">COMPLETE LABELING</a>
</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="Temazepam.CHEMICAL_FORMULA_AND_STRUCTURE"><h2 id="_Temazepam_CHEMICAL_FORMULA_AND_STRUCTURE_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figTemazepamTc"><a href="/books/NBK548556/table/Temazepam.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figTemazepamTc" rid-ob="figobTemazepamTc"><img class="small-thumb" src="/books/NBK548556/table/Temazepam.Tc/?report=thumb" src-large="/books/NBK548556/table/Temazepam.Tc/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Temazepam.Tc"><a href="/books/NBK548556/table/Temazepam.Tc/?report=objectonly" target="object" rid-ob="figobTemazepamTc">Table</a></h4></div></div></div><div id="Temazepam.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Temazepam_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 22 June 2023</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Temazepam.REF.zimmerman.1999">Zimmerman HJ. Benzodiazepines. Psychotropic and anticonvulsant agents. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 491-3.<div><i>(Expert review of benzodiazepines and liver injury published in 1999; mentions rare instances of cholestatic hepatitis have been reported due to alprazolam, chlordiazepoxide, diazepam, flurazepam, and triazolam, and hepatocellular injury with clorazepate and clotiazepam, but no reports of hepatic injury with lorazepam, oxazepam or temazepam).</i></div></div></li><li><div class="bk_ref" id="Temazepam.REF.larrey.2007">Larrey D. Benzodiazepines. Hepatotoxicity of psychotropic drugs and drugs of abuse. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 2nd ed. New York: Informa Healthcare USA, 2007, pp. 517.<div><i>(Review of drug induced liver injury published in 2007; rare instances of acute liver injury [usually cholestatic] have been reported with alprazolam, chlordiazepoxide, diazepam, flurazepam, and triazolam; a hepatitis-like pattern has been reported with clonazepam and clorazepate).</i></div></div></li><li><div class="bk_ref" id="Temazepam.REF.mihic.2018">Mihic SJ, Mayfield J, Harris RA. Hypnotics and sedatives. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman &#x00026; Gilman&#x02019;s the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 339-53.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Temazepam.REF.davion.1985.117">Davion T, Capron-Chivrac D, Andrejak M, Capron JP. <span><span class="ref-journal">Gastroenterol Clin Biol. </span>1985;<span class="ref-vol">9</span>:117&ndash;26.</span> [Hepatitis due to antiepileptic agents] [<a href="https://pubmed.ncbi.nlm.nih.gov/3920108" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 3920108</span></a>]<div>
<i>(Review of hepatotoxicity of anticonvulsants; among benzodiazepines, cases of cholestatic hepatitis have been linked to chlordiazepoxide and diazepam, but liver injury from this class of drugs is exceptionally rare).</i>
</div></div></li><li><div class="bk_ref" id="Temazepam.REF.lewis.1999.433">Lewis JH, Zimmerman HJ. Drug- and chemical-induced cholestasis. <span><span class="ref-journal">Clin Liver Dis. </span>1999;<span class="ref-vol">3</span>:433&ndash;64.</span> vii. Erratum in: Clin Liver Dis 1999; 3: 917. [<a href="https://pubmed.ncbi.nlm.nih.gov/11291233" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 11291233</span></a>]<div>
<i>(Review of drug induced cholestatic syndromes, listing many causes including chlordiazepoxide and flurazepam; &#x0201c;Benzodiazepines may cause cholestatic injury, although this is rare&#x0201d;).</i>
</div></div></li><li><div class="bk_ref" id="Temazepam.REF.bj_rnsson.2008.281">Bj&#x000f6;rnsson E. Hepatotoxicity associated with antiepileptic drugs. <span><span class="ref-journal">Acta Neurol Scand. </span>2008;<span class="ref-vol">118</span>:281&ndash;90.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/18341684" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 18341684</span></a>]<div>
<i>(Review of hepatotoxicity of all anticonvulsants focusing upon phenytoin, valproate, carbamazepine; &#x0201c;Furthermore, hepatoxicity has not been convincingly shown to be associated with the use of benzodiazepines&#x0201d;).</i>
</div></div></li><li><div class="bk_ref" id="Temazepam.REF7">Drugs for insomnia. <span><span class="ref-journal">Treat Guidel Med Lett. </span>2012;<span class="ref-vol">10</span>(119):57&ndash;60.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/22777275" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 22777275</span></a>]<div>
<i>(Guidelines for therapy of insomnia mentions that benzodiazepines are controlled substances and, when used for sleep, may impair next day performance).</i>
</div></div></li><li><div class="bk_ref" id="Temazepam.REF.bj_rnsson.2013.1419">Bj&#x000f6;rnsson ES, Bergmann OM, Bj&#x000f6;rnsson HK, Kvaran RB, Olafsson S. Incidence, presentation and outcomes in patients with drug-induced liver injury in the general population of Iceland. <span><span class="ref-journal">Gastroenterology. </span>2013;<span class="ref-vol">144</span>:1419&ndash;25.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/23419359" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 23419359</span></a>]<div>
<i>(In a population based study of drug induced liver injury from Iceland, 96 cases were identified over a 2 year period, but none were attributed to temazepam or any other benzodiazepine, despite the fact millions of prescriptions for them are filled yearly).</i>
</div></div></li><li><div class="bk_ref" id="Temazepam.REF.hern_ndez.2014.231">Hern&#x000e1;ndez N, Bessone F, S&#x000e1;nchez A, di Pace M, Brahm J, Zapata R, A, Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America. An analysis of published reports. <span><span class="ref-journal">Ann Hepatol. </span>2014;<span class="ref-vol">13</span>:231&ndash;9.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/24552865" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 24552865</span></a>]<div>
<i>(Systematic review of literature on drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases, none of which were attributed to a benzodiazepine).</i>
</div></div></li><li><div class="bk_ref" id="Temazepam.REF.chalasani.2015.1340">Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al. United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. <span><span class="ref-journal">Gastroenterology. </span>2015;<span class="ref-vol">148</span>:1340&ndash;1352.e7.</span> [<a href="/pmc/articles/PMC4446235/" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pmc">PMC free article<span class="bk_prnt">: PMC4446235</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25754159" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 25754159</span></a>]<div>
<i>(Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, no cases were attributed to temazepam or any other benzodiazepine).</i>
</div></div></li><li><div class="bk_ref" id="Temazepam.REF11">Drugs for chronic insomnia. <span><span class="ref-journal">Med Lett Drugs Ther. </span>2023;<span class="ref-vol">65</span>:1&ndash;6.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/36630579" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 36630579</span></a>]<div>
<i>(Concise review of drugs for chronic insomnia mentions that tolerance and dependence can occur with use of benzodiazepines and their use should be discouraged, and that benzodiazepines are CNS suppressants and can impair next day performance including driving and cause complex behavior disorders, retrograde amnesia, dependence, tolerance, abuse and rebound insomnia; no mention of ALT elevations or hepatotoxicity).</i>
</div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK548556_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">June 22, 2023</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a></div></div><h3>Publisher</h3><p><a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&amp;targetsite=external&amp;targetcat=link&amp;targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Temazepam. [Updated 2023 Jun 22].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Telotristat/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/livertox/Temozolomide/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="table-wrap" id="figobTemazepamTc"><div id="Temazepam.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548556/table/Temazepam.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Temazepam.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Temazepam.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Temazepam.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Temazepam.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Temazepam.Tc_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Temazepam.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Temazepam</td><td headers="hd_h_Temazepam.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/134979721" ref="pagearea=body&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubchem">846-50-4</a>
</td><td headers="hd_h_Temazepam.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C16-H13-Cl-N2-O2</td><td headers="hd_h_Temazepam.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/134979721" title="View this structure in PubChem" class="img_link" ref="pagearea=body&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&amp;sid=134979721" alt="image 134979721 in the ncbi pubchem database" /></a>
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