SgmlV1, Pmc, Corpus, bibRecord, 000179

Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012

Identifieur interne : 000179 ( Pmc/Corpus ); précédent : 000178; suivant : 000180

Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012

Auteurs : Carmen K. Wong ; Nathaniel S. Marshall ; Ronald R. Grunstein ; Samuel S. Ho ; Romano A. Fois ; David E. Hibbs ; Jane R. Hanrahan ; Bandana Saini

Source :

Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine [ 1550-9389 ] ; 2017.

RBID : PMC:5263078

Abstract

Study Objectives:

Stimulated reporting occurs when patients and healthcare professionals are influenced or “stimulated” by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006–2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored.

Methods:

Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012.

Results:

Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster.

Conclusions:

Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies.

Citation:

Wong CK, Marshall NS, Grunstein RR, Ho SS, Fois RA, Hibbs DE, Hanrahan JR, Saini B. Spontaneous adverse event reports associated with zolpidem in the United States 2003–2012. J Clin Sleep Med. 2017;13(2):223–234.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5263078

DOI: 10.5664/jcsm.6452
PubMed: 27784418
PubMed Central: 5263078

Links to Exploration step

PMC:5263078

Le document en format XML

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<author><name sortKey="Wong, Carmen K" sort="Wong, Carmen K" uniqKey="Wong C" first="Carmen K." last="Wong">Carmen K. Wong</name>
<affiliation><nlm:aff id="aff1">Faculty of Pharmacy, The University of Sydney, Sydney, Australia</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Marshall, Nathaniel S" sort="Marshall, Nathaniel S" uniqKey="Marshall N" first="Nathaniel S." last="Marshall">Nathaniel S. Marshall</name>
<affiliation><nlm:aff id="aff2">NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney, Australia</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="aff3">Sydney Nursing School, The University of Sydney, Sydney, Australia</nlm:aff>
</affiliation>
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<author><name sortKey="Grunstein, Ronald R" sort="Grunstein, Ronald R" uniqKey="Grunstein R" first="Ronald R." last="Grunstein">Ronald R. Grunstein</name>
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<author><name sortKey="Ho, Samuel S" sort="Ho, Samuel S" uniqKey="Ho S" first="Samuel S." last="Ho">Samuel S. Ho</name>
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<author><name sortKey="Fois, Romano A" sort="Fois, Romano A" uniqKey="Fois R" first="Romano A." last="Fois">Romano A. Fois</name>
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<author><name sortKey="Hibbs, David E" sort="Hibbs, David E" uniqKey="Hibbs D" first="David E." last="Hibbs">David E. Hibbs</name>
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<author><name sortKey="Hanrahan, Jane R" sort="Hanrahan, Jane R" uniqKey="Hanrahan J" first="Jane R." last="Hanrahan">Jane R. Hanrahan</name>
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<author><name sortKey="Saini, Bandana" sort="Saini, Bandana" uniqKey="Saini B" first="Bandana" last="Saini">Bandana Saini</name>
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<author><name sortKey="Marshall, Nathaniel S" sort="Marshall, Nathaniel S" uniqKey="Marshall N" first="Nathaniel S." last="Marshall">Nathaniel S. Marshall</name>
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<affiliation><nlm:aff id="aff3">Sydney Nursing School, The University of Sydney, Sydney, Australia</nlm:aff>
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<author><name sortKey="Grunstein, Ronald R" sort="Grunstein, Ronald R" uniqKey="Grunstein R" first="Ronald R." last="Grunstein">Ronald R. Grunstein</name>
<affiliation><nlm:aff id="aff2">NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney, Australia</nlm:aff>
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<author><name sortKey="Ho, Samuel S" sort="Ho, Samuel S" uniqKey="Ho S" first="Samuel S." last="Ho">Samuel S. Ho</name>
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</affiliation>
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<author><name sortKey="Fois, Romano A" sort="Fois, Romano A" uniqKey="Fois R" first="Romano A." last="Fois">Romano A. Fois</name>
<affiliation><nlm:aff id="aff1">Faculty of Pharmacy, The University of Sydney, Sydney, Australia</nlm:aff>
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<author><name sortKey="Hibbs, David E" sort="Hibbs, David E" uniqKey="Hibbs D" first="David E." last="Hibbs">David E. Hibbs</name>
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<author><name sortKey="Hanrahan, Jane R" sort="Hanrahan, Jane R" uniqKey="Hanrahan J" first="Jane R." last="Hanrahan">Jane R. Hanrahan</name>
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<author><name sortKey="Saini, Bandana" sort="Saini, Bandana" uniqKey="Saini B" first="Bandana" last="Saini">Bandana Saini</name>
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</affiliation>
<affiliation><nlm:aff id="aff2">NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney, Australia</nlm:aff>
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<idno type="ISSN">1550-9389</idno>
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<front><div type="abstract" xml:lang="en"><sec><title>Study Objectives:</title>
<p>Stimulated reporting occurs when patients and healthcare professionals are influenced or “stimulated” by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006–2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored.</p>
</sec>
<sec><title>Methods:</title>
<p>Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012.</p>
</sec>
<sec><title>Results:</title>
<p>Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster.</p>
</sec>
<sec><title>Conclusions:</title>
<p>Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies.</p>
</sec>
<sec><title>Citation:</title>
<p>Wong CK, Marshall NS, Grunstein RR, Ho SS, Fois RA, Hibbs DE, Hanrahan JR, Saini B. Spontaneous adverse event reports associated with zolpidem in the United States 2003–2012. <italic>J Clin Sleep Med.</italic>
 2017;13(2):223–234.</p>
</sec>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
  <front><journal-meta><journal-id journal-id-type="nlm-ta">J Clin Sleep Med</journal-id>
<journal-id journal-id-type="iso-abbrev">J Clin Sleep Med</journal-id>
<journal-id journal-id-type="publisher-id">JCSM</journal-id>
<journal-title-group><journal-title>Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine</journal-title>
</journal-title-group>
<issn pub-type="ppub">1550-9389</issn>
<issn pub-type="epub">1550-9397</issn>
<publisher><publisher-name>American Academy of Sleep Medicine</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">27784418</article-id>
<article-id pub-id-type="pmc">5263078</article-id>
<article-id pub-id-type="publisher-id">jc-00280-16</article-id>
<article-id pub-id-type="doi">10.5664/jcsm.6452</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Scientific Investigations</subject>
</subj-group>
</article-categories>
<title-group><article-title>Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Wong</surname>
<given-names>Carmen K.</given-names>
</name>
<degrees>BPharm</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Marshall</surname>
<given-names>Nathaniel S.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="aff2"><sup>2</sup>
</xref>
<xref ref-type="aff" rid="aff3"><sup>3</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Grunstein</surname>
<given-names>Ronald R.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff2"><sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Ho</surname>
<given-names>Samuel S.</given-names>
</name>
<degrees>BPharm</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Fois</surname>
<given-names>Romano A.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hibbs</surname>
<given-names>David E.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hanrahan</surname>
<given-names>Jane R.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Saini</surname>
<given-names>Bandana</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
<xref ref-type="aff" rid="aff2"><sup>2</sup>
</xref>
<xref ref-type="corresp" rid="cor1"></xref>
</contrib>
<aff id="aff1"><label>1</label>
Faculty of Pharmacy, The University of Sydney, Sydney, Australia</aff>
<aff id="aff2"><label>2</label>
NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney, Australia</aff>
<aff id="aff3"><label>3</label>
Sydney Nursing School, The University of Sydney, Sydney, Australia</aff>
</contrib-group>
<author-notes><corresp id="cor1">Address correspondence to: Bandana Saini, <addr-line>Faculty of Pharmacy, Room S303, Pharmacy Building A15, Science Road, The University of Sydney, Sydney, NSW 2006, Australia</addr-line>
<phone>+61 2 9351 6789</phone>
<fax>+61 2 9351 4391</fax>
<email>bandana.saini@sydney.edu.au</email>
</corresp>
</author-notes>
<pub-date pub-type="epub"><day>15</day>
<month>2</month>
<year>2017</year>
</pub-date>
<volume>13</volume>
<issue>2</issue>
<fpage>223</fpage>
<lpage>234</lpage>
<history><date date-type="received"><month>7</month>
<year>2016</year>
</date>
<date date-type="rev-recd"><month>9</month>
<year>2016</year>
</date>
<date date-type="accepted"><month>9</month>
<year>2016</year>
</date>
</history>
<permissions><copyright-statement>© 2017 American Academy of Sleep Medicine</copyright-statement>
<copyright-year>2017</copyright-year>
</permissions>
<abstract><sec><title>Study Objectives:</title>
<p>Stimulated reporting occurs when patients and healthcare professionals are influenced or “stimulated” by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006–2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored.</p>
</sec>
<sec><title>Methods:</title>
<p>Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012.</p>
</sec>
<sec><title>Results:</title>
<p>Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster.</p>
</sec>
<sec><title>Conclusions:</title>
<p>Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies.</p>
</sec>
<sec><title>Citation:</title>
<p>Wong CK, Marshall NS, Grunstein RR, Ho SS, Fois RA, Hibbs DE, Hanrahan JR, Saini B. Spontaneous adverse event reports associated with zolpidem in the United States 2003–2012. <italic>J Clin Sleep Med.</italic>
 2017;13(2):223–234.</p>
</sec>
</abstract>
<kwd-group><kwd>zolpidem</kwd>
<kwd>sleepwalking</kwd>
<kwd>sleep-driving</kwd>
<kwd>parasomnia</kwd>
<kwd>media publicity</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>

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Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012

Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012

Source :

Abstract

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki