Direct healthcare professional communications (DHPC)
STILNOX® 10 mg film-coated tablet (zolpidem): Restriction of indication
Written by Seksyen Farmakovigilans · 29 July 2018
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.