Zolpidem-containing medicines

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision
Current status:
European Commission final decision

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
Approved name
Zolpidem-containing medicines
International non-proprietary name (INN) or common name
zolpidem
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1377
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
11/07/2013
PRAC recommendation date
06/03/2014
CHMP opinion/CMDh position date
24/04/2014
EC decision date
23/06/2014
Outcome
Risk minimisation measures

All documents

Procedure started

  • List item

    Zolpidem Article-31 referral - Annex I (PDF/736.13 KB)


    First published: 12/07/2013
    Last updated: 04/08/2014
    EMA/428277/2013

  • List item

    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

  • List item

    Zolpidem Article-31 referral - Review started (PDF/75.27 KB)


    First published: 12/07/2013
    Last updated: 12/07/2013
    EMA/417529/2013

  • List item

    Zolpidem Article-31 referral - PRAC list of questions (PDF/67.81 KB)

    Adopted

    First published: 12/07/2013
    Last updated: 12/07/2013
    EMA/PRAC/418738/2013

  • List item

    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

    Position provided by CMDh

  • List item

    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

  • List item

    Zolpidem Article-31 referral - Annex III (PDF/58.94 KB)


    First published: 25/04/2014
    Last updated: 04/08/2014

  • European Commission final decision

  • List item

    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

  • List item

    Zolpidem Article-31 - Annex II (PDF/44.17 KB)


    First published: 04/08/2014
    Last updated: 04/08/2014

  • List item

    Zolpidem Article-31 referral - CMDh divergent position (PDF/28.17 KB)


    First published: 04/08/2014
    Last updated: 04/08/2014

  • List item

    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

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