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10 Mar 2014

PRAC Recommends Product Information of Zolpidem be Updated

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of zolpidem-containing medicines, used for the short-term treatment of insomnia (inability to sleep). The benefit–risk balance of these medicines remains positive, but the PRAC recommended changes to the product information, which are aimed at further minimising the known risks of next-morning impaired driving ability and mental alertness (including somnambulism).


The review of zolpidem was initiated after reports of impaired driving or road accidents the morning after patients took the medicine. It is well known that medicines such as zolpidem may cause drowsiness and slower reactions the day after taking the medicine, which could increase the risk of accidents during activities that require alertness such as driving, and the zolpidem product information already contains a warning of this risk. However, it was considered that a detailed review and analysis involving additional information on the benefits and risks of zolpidem, including information on its effectiveness and risks at lower doses, was needed to decide whether any changes should be made to the marketing authorisations of these products across the EU.


The PRAC has now recommended changes to the product information of zolpidem, including further highlighting the risks of impaired driving and mental alertness and strengthening warnings and precautions aimed at minimising these risks. The PRAC considered that the recommended daily dose should remain at 10 mg of zolpidem, and this dose must not be exceeded. Patients should take the lowest effective dose, in a single intake just before going to bed, and the medicine should not be taken again during the same night. In elderly patients and in patients with reduced liver function, the recommended dose remains 5 mg of zolpidem per day. Furthermore it is recommended not to drive or perform activities that require mental alertness until 8 hours after taking zolpidem. Zolpidem should not be taken together with other medicines that have an effect on the central nervous system (brain and spinal cord). Similarly, alcohol or other substances that affect mental function should not be used when taking zolpidem.


The PRAC recommendation will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration at its meeting on 22–24 April 2014.[1]


[1] The companies that market zolpidem have the right to ask for a re-examination of the PRAC recommendation within 15 days of receipt of the PRAC recommendation, which would delay the expected time of finalisation of this review.


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