Other safety alerts
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| Singapore: STILNOX (zolpidem) – Measures taken to further mitigate the risk of dependence and abuse |
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Health Sciences Authority (HSA) announces that Sanofi-aventis would like to inform healthcare professionals about measures taken to further mitigate the risk of dependence and abuse with zolpidem. These measures will be implemented via restriction of indication and strengthening of safety information in the local package inserts (PI) for STILNOX (both immediate-release and extended-release formulations). Healthcare professionals are reminded of the information that is present or will be updated in the STILNOX PI, including restriction of indication to short-term treatment of insomnia, recommendations on treatment duration and warnings on risk of dependence and abuse.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../stilnox-zolpidemmeasurestakentofurthermitigatetheriskofdependenc.html
In Hong Kong, there are 19 registered pharmaceutical products containing zolpidem, and all products are prescription-only medicines. Recommendation on short-term use of the drug and the risk of dependence and abuse are documented in reputable drug references such as Martindale: The Complete Drug Reference. So far, the Department of Health (DH) has received three cases of adverse drug reaction related to zolpidem, of which one case was related to drug dependence. DH will remain vigilant on safety update of zolpidem issued by HSA and other overseas drug regulatory authorities.
Ends/Wednesday, May 16, 2018
Issued at HKT 15:00
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