Stilnox ® 10mg Film-Coated Tablet (zolpidem): Restriction of indication

User Rating: 5 / 5

Star ActiveStar ActiveStar ActiveStar ActiveStar Active
 

 

Description:

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:

  • The new restriction of indication of Stilnox ® is for short-term treatment of insomnia.
  • The usual dose is 10 mg per day; a lower starting dose of 5 mg is recommended for elderly and patients with hepatic impairment.
  • The duration of treatment of Stilnox ® should be as short as possible, not exceeding 4 weeks.

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.

 

 

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

DISCLAIMER

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.

Mobile Web :

© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA