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

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Description:

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:

  • Restriction of the indication to short-term treatment of insomnia.
  • The recommended dose is 7.5 mg daily for adults, and a lower starting dose of 3.75 mg for elderly patients and patients with hepatic insufficiency, renal insufficiency or chronic respiratory insufficiency.
  • The duration of treatment should be as short as possible, not exceeding 4 weeks.
  • Strengthening of the wording in the Precautions section regarding the risk of dependence and abuse.

 

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.

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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