Stilnox® 10 mg film-coated tablet (zolpidem): Restriction of indication


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The risk of developing abuse and dependence with zolpidem has been found to increase with a treatment duration above 28 days and in patients with previous or concomitant history of alcohol or drug abuse.

Following a safety review of all available data on abuse and dependence of zolpidem, the product packaging insert of Stilnox® has been updated with a new restriction of indication, strengthening of dosage administration and inclusion of new safety information in the warnings and precautions, including:


A Direct Healthcare Professional Communication (DHPC) letter has been issued by Sanofi-Aventis (Malaysia) Sdn. Bhd. in agreement with the NPRA to highlight this safety issue. Please refer to this DHPC for more information.