CPMP RECOMMENDATIONS ON HYPNOTIC DRUGS
The European Community's Committee for Proprietary Medicinal Products has issued its recommendations on the relative risk/benefit ratio of seven short-acting hypnotics, and concluded that their use is only justified for short periods in cases where the sleep disorder is particularly severe, disabling or subjecting the patient to extreme distress.
The controversy over the use of these agents started in 1991 when France and the Netherlands requested an opinion from the CPMP on Upjohn's Halcion (triazolam), a hypnotic which had been linked to the development of psychotic reactions. The CPMP compiled a report on the matter in December 1991, in which a full assessment of the risk/benefits of short-acting hypnotics was requested, and as a result an ad hoc group, chaired by CPMP vice-chairman Prof J M Alexandre, was set up to expedite the review.
The review considered the following hypnotics - brotizolam, midazolam, triazolam, flunitrazepam, temazepam, zolpidem and zopiclone. The recommendations made by the ad hoc group are as follows:
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