Spontaneous adverse event reports associated with zolpidem in Australia 2001-2008

Abstract

SUMMAR Y A prominent media publicity cluster during [2007][2008] in Australia linked the common hypnotic zolpidem to adverse drug reaction reports of parasomnias, amnesia, hallucinations and suicidality. The collection of adverse drug reaction data through spontaneous reporting systems is a mainstay of drug safety monitoring, but a stimulated reporting event such as this often renders such data uninterpretable.As such, we aimed to investigate whether these associations were present before the media cluster and then to quantify the effect of stimulated reporting on those four specific outcomes. Using disproportionality analyses we compared zolpidem to all other drugs in the database, and then separately to each of all hypnotics, then all benzodiazepines, and then temazepam alone, and did so in every year from 2001 to 2008. Year-by-year analyses of Reporting odds ratios for zolpidem exposure and adverse events of interest, adjusted for a number of covariates, revealed an association between zolpidem exposure and parasomnias, amnesia and hallucination both before and after the cluster of media publicity beginning in early 2007. The odds ratios increased significantly after the media publicity for only parasomnias and amnesia. Suicidality was increased in some analyses, but limited data make this outcome difficult to interpret. We conclude that zolpidem adverse drug reaction reports have higher odds for parasomnia, amnesia, hallucination and perhaps suicidality compared to either all other drugs or hypnotics, even before the media publicity cluster. However, the extant literature and the limitations of these spontaneously reported adverse drug reaction data do not allow us to conclude that these events are related causally to zolpidem.k e y w o r d s insomnia, sleep, sleepdriving, sleepwalking

Time Trends in the Family Physician Management of Insomnia: The Australian Experience (2000–2015)

“…The apparent decrease in the management rate of "old" insomnia problems between 2006 to 2008 was not statistically significant using the nonoverlapping 95% CI rule. However, because of our previous observations about the stimulated reporting event year, 22,25 we then decided to apply the same z test to data pooled before and af- …”

“…20 Zolpidem-related side effects became the subject of intense media scrutiny in 2007-2008. 21,22 Later in 2008, the Australian Therapeutic Goods Administration imposed a black box warning in the product information for zolpidem. 23,24 Only the United States and Australia seem to have been subject to sustained media interest in these side effects.…”

“…Earlier cross-sectional analyses of these data (2006)(2007)(2008) 27 found that pharmacotherapy was prescribed by FPs at a rate of 95.2 medications per 100 insomnia problems. Since that report was published, significant changes in insomnia management are likely to have occurred due to the zolpidem-related stimulated reporting event 21,22,25,28 and the introduction of important new hypnotics such as slow-release melatonin (marketed as Circadin in Europe since 2007 and Australia since 2009). 29,30 In addition, there have been anecdotal reports of off-label prescriptions of low doses (50 mg) of the antipsychotic quetiapine (tradename: Seroquel) for insomnia.…”

Primary health care practitioner perspectives on the management of insomnia: a pilot study

“…It became by far the most prescribed nonbenzodiazepine GABA receptor ligand in 2006-07, with it being used for around 15% of insomnia problems (Charles et al 2009;Marshall et al 2011). Zolpidem prescriptions halved over the next 2 years following publicity concerning bizarre behaviours in some patients and a sustained media interest in the side-effect profile of zolpidem (Ben-Hamou et al 2011). Although the practicing environment and culture can affect the quality of health care delivery (Eisenberg et al 2001), it is unknown the extent to which these events have impacted on the routine management of insomnia among key primary care service providers.…”

Pharmacists' perceptions and communication of risk for alertness impairing medications

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