Ambien sleeping pill side effects 'rare': Sanofi

23rd March 2006, Comments 0 comments

WASHINGTON, March 23, 2006 (AFP) - French pharmaceutical group Sanofi-Aventis defended the safety of Ambien, the top selling sleeping pill in the world, which faces a class-action lawsuit that says it causes sleepwalking and eating disorders.

WASHINGTON, March 23, 2006 (AFP) - French pharmaceutical group Sanofi-Aventis defended the safety of Ambien, the top selling sleeping pill in the world, which faces a class-action lawsuit that says it causes sleepwalking and eating disorders.

Sanofi-Aventis said in a statement it has put the drug under a battery of clinical tests and reviewed all the data from 70,000 users who say there is nothing wrong with the dosage instructions and warning label it carries.

Four Ambien users in March filed a lawsuit against Sanofi-Aventis in a federal court in New York, claiming the sleeping pill drove them to eat excessively or drive while sleepwalking, leaving them with no memory of their actions.

They called on everybody who had similar experiences to join them in a class action suit.

Ambien, which sells under the name of Stilnox in France, does specify in its warning label that one of its rare side effects is somnambulism and increased appetite, the company said in its statement.

According to the US Food and Drug Administration, to be considered "rare" a side effect must occur less than one in 1,000 cases. The FDA approved Ambien for marketing in the United States in 1993. It generates US $1.8 billion in worldwide sales for the company.

In its statement, Sonofi-Aventis said it was "important that Ambien only be taken under a doctor's supervision, as outlined in the US Prescribing Information."

Lawyers for the company and the plaintiffs are scheduled to hold a preliminary meeting in June before going to trial.

Copyright AFP

Subject: French news

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