Imovane® (zopiclone): New restriction of the indication and additional warnings on abuse and dependence


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Zopiclone is a hypnotic agent, indicated for the treatment of insomnia. It is recommended to be used for the shortest duration possible, and not exceeding 4 weeks.

The risk of developing abuse and dependence with zopiclone increases with a treatment duration above 28 days and in patients with previous or concomitant history of alcohol or drug abuse. After reviewing all the available data on abuse and dependence of zopiclone, additional measures have been implemented to minimize these risks.


The package insert of Imovane® Tablet 7.5 mg has been updated with new information on indication, recommended dosage, and duration of treatment, as follows:


NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Sanofi–aventis (Malaysia) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.