Zolpidem-containing medicines
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh position
- European Commission final decision
Table of contents
Overview
New advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem
On 24 April 2014, the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 endorsed by majority new recommendations for zolpidem-containing medicines, used for the short-term treatment of insomnia (difficulty sleeping). The CMDh agreed that the benefit-risk balance of these medicines remains positive; however, some changes have been made to the product information to minimise the known risk of reduced mental alertness and impaired ability to drive and use machinery the morning after use.
These recommendations followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety of zolpidem with regards to the risk of impaired driving, somnambulism, and reduced mental alertness (such as drowsiness and slower reactions) after taking the medicine, and information on its effectiveness at lower doses.
Changes made to the product information of zolpidem-containing medicines include strengthened warnings and precautions. The normal recommended daily dose in adults, which must not be exceeded, remains at 10 mg, and for older patients and patients with reduced liver function it remains at 5 mg. Patients should take the lowest effective dose of zolpidem in a single intake just before going to bed and should not take another dose during the same night. Furthermore, patients should not drive or perform activities that require mental alertness for at least 8 hours after taking zolpidem. Since the risk of impaired driving seems to increase if zolpidem is taken together with other medicines that have an effect on the central nervous system (brain and spinal cord), or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.
As the CMDh position on zolpidem was adopted by majority vote, it was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 23 June 2014.
Key facts
About this medicine
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Approved name |
Zolpidem-containing medicines
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International non-proprietary name (INN) or common name |
zolpidem |
About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/A-31/1377
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Type | |
Decision making model |
PRAC-CMDh
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Authorisation model |
Nationally authorised product(s)
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Key dates and outcomes
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Procedure start date |
11/07/2013
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PRAC recommendation date |
06/03/2014
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CHMP opinion/CMDh position date |
24/04/2014
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EC decision date |
23/06/2014
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Zolpidem Article-31 referral - Annex I (PDF/736.13 KB)
First published: 12/07/2013
Last updated: 04/08/2014
EMA/428277/2013
Zolpidem Article-31 referral - Timetable for the procedure (PDF/70.39 KB)
First published: 12/07/2013
Last updated: 06/12/2013
EMA/PRAC/418739/2013 Rev. 1
Zolpidem Article-31 referral - Review started (PDF/75.27 KB)
First published: 12/07/2013
Last updated: 12/07/2013
EMA/417529/2013
Zolpidem Article-31 referral - PRAC list of questions (PDF/67.81 KB)
First published: 12/07/2013
Last updated: 12/07/2013
EMA/PRAC/418738/2013
Zolpidem Article-31 referral - Notification (PDF/30.55 KB)
First published: 12/07/2013
Last updated: 12/07/2013
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Zolpidem Article-31 referral - PRAC assessment report (PDF/222.23 KB)
First published: 04/08/2014
Last updated: 04/08/2014
EMA/418370/2014
PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness (PDF/69.43 KB)
First published: 07/03/2014
Last updated: 07/03/2014
EMA/129598/2014
Position provided by CMDh
CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem (PDF/78.82 KB)
First published: 25/04/2014
Last updated: 25/04/2014
EMA/240581/2014
Zolpidem Article-31 referral - Annex III (PDF/58.94 KB)
First published: 25/04/2014
Last updated: 04/08/2014
European Commission final decision
Zolpidem Article-31 - Annex II (PDF/44.17 KB)
First published: 04/08/2014
Last updated: 04/08/2014
Zolpidem Article-31 referral - CMDh divergent position (PDF/28.17 KB)
First published: 04/08/2014
Last updated: 04/08/2014
New advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem (PDF/98 KB)
First published: 04/08/2014
Last updated: 04/08/2014
EMA/427574/2014
Document description
- Annex I - List of the medicines affected by the referral
- Annex II - Scientific conclusions of the CHMP or CMDh
- Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
- Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
- Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
- Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
- PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
- PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
- PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated