§ Mr. Radice
To ask the Secretary of State for Health (1) what evidence she holds on the dependence risk of zoplicone in clinical usage;
(2) what representations have been made by her Department since 1989 to the manufacturers of Zimovane, in respect of their claims that there is no evidence of dependence in clinical use; and what was the outcome;
(3) what action she proposes to take against the manufacturers of Zimovane in respect of their claims that there is no evidence of dependence in clinical use.
§ Mr. Sackville
When zopiclone—Zimovane—was first marketed in 1989, there was no evidence from clincial studies that the drug could cause dependence. The safety data obtained post-marketing suggest that the drug has some dependence potential. These data indicate that the risk of dependence increases with dose and duration of treatment and is great in patients with a history of alcohol and drug abuse. There is little evidence of dependence if the drug is used at the licensed doses for no more than four weeks.
The manufacturers changed the prescribing information in 1990 and 1992 at the request of the Medicines Control Agency—MCA—to reflect post-marketing experience. The promotional material for zopiclone now states that the drug has minimal dependence potential when used in the short term; this claim is consistent with the available scientific evidence. The European Community Committee for Proprietary Medicinal Products is reviewing the dependence potential of all short-acting hypnotic drugs, including zopiclone. The prescribing information on dependence for all hypnotics may be amended by the MCA as a result of this review.