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yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</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="_NBK548924_"><span class="title" itemprop="name">Zaleplon</span></h1><p class="fm-aai"><a href="#_NBK548924_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Zaleplon.OVERVIEW"><h2 id="_Zaleplon_OVERVIEW_">OVERVIEW</h2><div id="Zaleplon.Introduction"><h3>Introduction</h3><p>Zaleplon is a benzodiazepine receptor agonist and hypnotic that is used as a sleeping pill. Zaleplon has not been implicated in causing serum enzyme elevations or clinically apparent liver injury.</p></div><div id="Zaleplon.Background"><h3>Background</h3><p>Zaleplon (zal' e plon) is a non-benzodiazepine, benzodiazepine receptor agonist of the pyrazolopyrimide class that acts by binding to the benzodiazepine (BZ) site on the GABA receptor complex, causing neural inhibition and helping to induce sleep. Zaleplon has selectivity for certain BZ receptor subtypes and does not have the neuromuscular relaxation or anticonvulsant effects of the standard benzodiazepines. Zaleplon has a short half life and rapid onset of action. In multiple placebo-controlled trials, zaleplon was shown to decrease the latency to onset of sleep and improve perceived sleep quality with few next day residual effects and little evidence of rebound insomnia after withdrawal. Zaleplon was approved for use in the United States in 1999 for the short term treatment of insomnia and it remains in wide use. Zaleplon is available in 5 and 10 mg capsules generically and under the brand name Sonata. The recommended dose is one 5 or 10 mg tablet taken orally immediately before bedtime. Like the other benzodiazepine receptor agonists, zaleplon is classified as a Schedule IV controlled substance (low potential for abuse and limited physical or psychological dependence). Side effects are uncommon, usually mild and may include headache, nausea, dizziness and drowsiness.</p></div><div id="Zaleplon.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In multiple premarketing randomized controlled trials, zaleplon was not associated with an increased rate of serum enzyme elevations in comparison to placebo therapy, and no instance of clinically apparent liver injury was reported. Since its approval and widescale use, zaleplon has not been implicated in causing clinically apparent liver disease. Nevertheless, zaleplon is metabolized in the liver by the cytochrome P450 system (predominantly CYP 3A4) and can cause drug-drug interactions, although such interactions appear to be rare. Thus, zaleplon induced liver injury must be rare, if it occurs at all.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p><p>Drug Class: <a href="/books/n/livertox/Sedatives_Hypnotics/?report=reader">Sedatives and Hypnotics</a></p><p>Other Drugs in the Subclass, Benzodiazepine Receptor Agonists: <a href="/books/n/livertox/Eszopiclone/?report=reader">Eszopiclone</a>, <a href="/books/n/livertox/Zolpidem/?report=reader">Zolpidem</a></p></div></div><div id="Zaleplon.PRODUCT_INFORMATION"><h2 id="_Zaleplon_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div id="Zaleplon.BPI" class="box boxed-text-box whole_rhythm hide-overflow"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Zaleplon – Generic, Sonata®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Sedatives and Hypnotics</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Zaleplon" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div></div><div id="Zaleplon.CHEMICAL_FORMULA_AND_STRUCTURE"><h2 id="_Zaleplon_CHEMICAL_FORMULA_AND_STRUCTURE_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figZaleplonT1"><a href="/books/NBK548924/table/Zaleplon.T1/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figZaleplonT1" rid-ob="figobZaleplonT1"><img class="small-thumb" src="/books/NBK548924/table/Zaleplon.T1/?report=thumb" src-large="/books/NBK548924/table/Zaleplon.T1/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Zaleplon.T1"><a href="/books/NBK548924/table/Zaleplon.T1/?report=objectonly" target="object" rid-ob="figobZaleplonT1">Table</a></h4></div></div></div><div id="Zaleplon.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Zaleplon_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 20 February 2018</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Zaleplon.R1">Zimmerman HJ. Anxiolytic 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 hepatotoxicity published in 1999 discusses benzodiazepines and minor tranquilizers, but not the benzodiazepine receptor agonists; "In general, the hepatotoxic potential of this widely used group of compounds seems low").</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R2">Larrey D, Ripault MP. Anxiolytic agents. Hepatotoxicity of psychotropic drugs and drugs of abuse. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, p. 455-6.<div><i>(Review of hepatotoxicity of hypnotics and sedatives discusses benzodiazepines, buspirone and valerian all of which have been linked to rare cases of liver injury; no discussion of zaleplon).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R3">Mihic SJ, Harris RA. Hypnotics and sedatives. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 457-80.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R4">Israel AG, Kramer JA. Safety of zaleplon in the treatment of insomnia. Ann Pharmacother 2002; 36: 852-9. [<a href="https://pubmed.ncbi.nlm.nih.gov/11978165" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11978165</span></a>]<div><i>(Review of side effects and safety of both short and long term use of zaleplon in treatment of insomnia; no mention of ALT elevations or clinically apparent liver injury).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R5">Roblin X, Boudemaghe T, Paris F, Pellissier L, Le Gall S. [Unexplained increase in aminotransferases and obstructive sleep apnea syndrome]. Gastroenterol Clin Biol 2002; 26: 416-7. French. [<a href="https://pubmed.ncbi.nlm.nih.gov/12070418" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12070418</span></a>]<div><i>(45 year old woman found to have minor serum ALT elevations [1.5-3 times ULN] without jaundice or symptoms while taking zolpidem, which improved on stopping, but which were subsequently shown to be due to severe sleep apnea).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R6">Moore KA, Zemrus TL, Ramcharitar V, Levine B, Fowler DR. Mixed drug intoxication involving zaleplon ("Sonata"). Forensic Sci Int 2003; 134: 120-2. [<a href="https://pubmed.ncbi.nlm.nih.gov/12850405" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12850405</span></a>]<div><i>(41 year old woman died of overdose of multiple agents including zaleplon; liver histology not mentioned).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R7">Drover DR. Comparative pharmacokinetics and pharmacodynamics of short-acting hypnosedatives: zaleplon, zolpidem and zopiclone. Clin Pharmacokinet 2004; 43: 227-38. [<a href="https://pubmed.ncbi.nlm.nih.gov/15005637" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15005637</span></a>]<div><i>(Review of mechanism of action, pharmacology, efficacy and adverse effects of 3 non-benzodiazepine hypnotic agents: zaleplon, zolpidem and zopiclone).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R8">Drugs for insomnia. Treat Guidel Med Lett 2012; 10 (119): 57-60. [<a href="https://pubmed.ncbi.nlm.nih.gov/22777275" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22777275</span></a>]<div><i>(Guidelines for therapy of insomnia; mentions that benzodiazepine receptor agonists such as zaleplon, benzodiazepines, ramelteon and low doses of doxepin are effective and generally safe; in discussing adverse events, makes no mention of ALT elevations or hepatotoxicity of any of the recommended agents).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R9">Björnsson ES, Bergmann OM, Björnsson HK, Kvaran RB, Olafsson S. Incidence, presentation and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology 2013; 144: 1419-25. [<a href="https://pubmed.ncbi.nlm.nih.gov/23419359" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&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 a sleeping aid, despite the fact that zopiclone and zolpidem are among the 25 most commonly prescribed drugs in Iceland).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R10">Hernández N, Bessone F, Sánchez 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. Ann Hepatol 2014; 13: 231-9. [<a href="https://pubmed.ncbi.nlm.nih.gov/24552865" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24552865</span></a>]<div><i> (Systematic review of literature of drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases, but none were attributed to zaleplon or other sedatives or sleeping aids).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R11">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. Gastroenterology 2015; 148: 1340-52.e7. [<a href="/pmc/articles/PMC4446235/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&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&targetsite=entrez&targetcat=link&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, 82 [9%] were attributed to agents active in the central nervous system, but none were due to zaleplon or other sedatives or sleeping aids).</i></div></div></li><li><div class="bk_ref" id="Zaleplon.R12">Drugs for insomnia. Med Lett Drugs Ther 2015; 57 (1472): 95-8. [<a href="https://pubmed.ncbi.nlm.nih.gov/26147892" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26147892</span></a>]<div><i> (Concise review of the mechanism of action, efficacy, safety and costs of drugs for insomnia including benzodiazepine receptor agonists including zaleplon as well as benzodiazepines, melatonin receptor agonists, orexin receptor antagonists and other agents including nonprescription and herbal products; 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="_NBK548924_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">February 20, 2018</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&targetsite=external&targetcat=link&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-. Zaleplon. [Updated 2018 Feb 20].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Zafirlukast/?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/Zanamivir/?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="boxed-text" id="figobZaleplonBPI"><div id="Zaleplon.BPI" class="box boxed-text-box whole_rhythm hide-overflow"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Zaleplon – Generic, Sonata®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Sedatives and Hypnotics</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Zaleplon" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div></article><article data-type="table-wrap" id="figobZaleplonT1"><div id="Zaleplon.T1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548924/table/Zaleplon.T1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Zaleplon.T1_lrgtbl__"><table><thead><tr><th id="hd_h_Zaleplon.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">DRUG</th><th id="hd_h_Zaleplon.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Zaleplon.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Zaleplon.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Zaleplon.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Zaleplon</td><td headers="hd_h_Zaleplon.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">151319-34-5</td><td headers="hd_h_Zaleplon.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">C17-H15-N5-O</td><td headers="hd_h_Zaleplon.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">
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<div class="graphic"><img src="/books/NBK548924/bin/Zaleplon_Structure.jpg" alt="Zaleplon Chemical Structure" /></div>
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