Sleep-related adverse events associated with zolpidem have been a concern in Australia for several years. 5–9 In 2008 the National Drugs and Poisons Schedule Committee considered whether zoldipem should be reclassified as a schedule 8 drug in Australia in response to reported incidents of bizarre and sometimes dangerous sleep-related behaviours such as sleep walking and sleep driving in some users of the drug. 7 The National Drugs and Poisons Schedule Committee considered that the current schedule 4 classification of zolpidem remained appropriate; 7 however, the TGA imposed a boxed safety warning on the PI of all zolpidem-containing medicines:
... while there is evidence of some extreme side effects in some people, the TGA has determined that used properly this is a medicine of value to some patients, particularly with severe insomnia, and should remain available in Australia.
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Date published: 23 January 2013 About this date.
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In the US, manufacturers of a number of zolpidem products will be required by the FDA to lower the recommended bedtime doses in order to lower drug levels in the blood the next morning. 1 The FDA recommends that doses for women should be lowered from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for extended-release products. 1 The FDA is also requiring label changes urging prescribers to consider these lower doses for men. 1 Lower doses are already recommended for elderly patients and patients with hepatic impairment, and zolpidem is contraindicated in patients with severe hepatic impairment.
This new evidence, along with data from clinical trials, driving simulation studies and about 700 reports linking zolpidem to ‘impaired driving ability and/or road traffic accidents’ 2 has led to the new US warning and recommendations. 1,2.
The TGA reports that the annual number of adverse events is decreasing since the introduction of the new warning in the PI. 8 In July 2012 the TGA published a statement explaining:
In addition to the warning, from December 2007 pack sizes have been limited to no more than 14 tablets. 6.
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New data show that in some patients blood levels of the insomnia drug zolpidem may be high enough after bedtime dosing to impair activities that require alertness the next morning. 1 The FDA has recommended that the bedtime dose should be lowered in women, and considered for lowering in men, to reduce residual blood levels the next morning. 1.
In Australia 1338 adverse events involving zolpidem medicines had been reported to the TGA by October 2012. 10 These events include 392 abnormal sleep-related events, 25 deaths and 20 road traffic accidents. 10 Between January 2009 and April 2012 zolpidem medicines were linked to 15% of road traffic accidents reported to the TGA. 9.
In pharmacokinetic trials: 1.
The US Food and Drug Administration (FDA) recently released a Drug Safety Communication announcement calling for a 50% reduction in bedtime doses of insomnia drug zolpidem, especially in women. Analysis of new safety data links bedtime doses with next-morning impairment of alertness sufficient to impair driving and other skills in some patients. For both men and women the FDA advise that controlled-release formulations of the drug are most likely to cause next-morning impairment after bedtime; women appear to be more susceptible to this risk because they eliminate zolpidem more slowly than men.
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... zolpidem may be associated with potentially complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS depressant drugs. Limit use to 4 weeks maximum under close medical supervision. 5.
and that ‘There is no specific new safety signal of concern to the TGA that would require the TGA to take further action at this time’. 8.
In Australia a number of sleep-related adverse events in people taking zolpidem have been reported to the Therapeutic Goods Administration (TGA), which continues to monitor the drug closely. In recent years safety warnings have been added to the product information (PI), and pack sizes have been reduced to 14 tablets in an attempt to reduce adverse events.
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The FDA is especially concerned about extended-release forms of zolpidem, 3 which the new data show are associated with the highest risk of next-morning impairment 1. Women appear to be more susceptible to this risk because they eliminate zolpidem more slowly than men. 1.
Date published: 23 Jan 2013 22 Jul 2014.
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A range of immediate-release and controlled-release zolpidem products is available in Australia (see Table 1). 4.