The review of zolpidem-containing medicines was initiated on 4 July 2013 at the request of the Italian Medicines Agency, after reports of impaired driving or road accidents the morning after patients took the medicine.
On the basis of its review, the PRAC has recommended that changes be made to the product information, including further highlighting the risks of impaired driving and mental alertness and strengthening warnings and precautions aimed at minimising these risks.
This is advice from the PRAC and final recommendations from the EMA are awaited. There is currently no related MHRA guidance available to assess implications for practice in the UK.