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

User Rating: 4 / 5

Star ActiveStar ActiveStar ActiveStar ActiveStar Inactive



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 (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400




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 :

Site Last Modified

  • Last Modified: Thursday 18 July 2024, 17:26:10.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA


Main Menu English