WC500165698

Discussion
The PRAC discussed the evidence on the risks of next-morning impaired driving ability and
somnambulism in the context of the use of zolpidem for the short-term treatment of insomnia. It was
agreed that to mitigate these risks the product information of zolpidem containing medicines should be
updated, to include strengthened warnings and precautions and enhanced information on interactions
with other medicinal products that can increase these risks. It was also recommended that there
should be a rest period of at least 8 hours after zolpidem administration before performing activities
that require mental alertness such as driving. The PRAC considered that the recommended daily dose
should remain at 10 mg of zolpidem, and that this dose must not be exceeded; zolpidem should be
taken as a single intake immediately at bedtime without being re-administered during the same night.
The PRAC agreed that the available efficacy data did not provide robust evidence that a lower dose was
effective on a population level. However, it also considered that there were some data indicating that
in some individual patients a lower dose could be effective and therefore patients should take the
lowest effective dose. This information should also be reflected in the product information. In elderly
patients and in patients with reduced liver function, the recommended dose remains 5 mg of zolpidem
per day.
Summary of recommendation(s)/conclusions
The PRAC adopted, by majority, the variation of the marketing authorisations for zolpidem-containing
medicines and adopted a recommendation to be considered by CMDh—see communication ‘PRAC
recommends product information of zolpidem be updated with new advice to minimise the risk of nextmorning
impaired driving ability and mental alertness’ EMA/129598/2014.
Thirty members, voted in favour of the variation together with Iceland and Norway, while one member
had a divergent view 2 .
3.4. Re-examination procedures
3.4.1. Diacerein (NAP)
Re-examination procedure of the PRAC recommendation following the review of the benefit-risk
balance following notification by France of a referral under Article 31 of Directive 2001/83/EC
based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Margarida Guimarães (PT)
PRAC Co-Rapporteur: Harald Herkner (AT)
Administrative details:
Procedure number: EMEA/H/A-31/1349
EPITT 15994 – Follow-up December 2013
MAH(s): Negma-Wockhardt, TRB Chemedica
Oral Explanation(s): Negma-Wockhardt, TRB Chemedica
Background
Following a request for a re-examination of the PRAC recommendation on diacerein-containing
medicines, provided under Article 31 of Directive 2001/83/EC ,and submission of grounds for this re-
2 The relevant AR containing the divergent views will be published on the EMA website once the procedure is fully
concluded.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 13/64