BRIDGEWATER, N.J., March 20 (UPI) -- Amid recent reports of "sleep bingeing" and other alarming side effects allegedly caused by Ambien, its maker is speaking out.
Sanofi-Aventis said in a statement issued Monday, "Recent anecdotal reports in the media have focused on rare occurrences of sleepwalking and sleep-related eating in patients who may also be taking Ambien.
"The safety profile of Ambien is well established and reported in the Ambien Prescribing Information approved by the U.S. Food and Drug Administration (FDA)," the drug maker said.
The company added that, in its own "thorough analysis" it "has not observed any significant change in that safety profile of Ambien" but conceded that "somnambulism is a possible rare adverse event."
And just how rare?
Sanofi-Aventis said, "One source estimates the incidence of sleepwalking in the general adult population is approximately 4 (percent). Further, patients who experience sleep disorders have been shown to have an increased propensity of sleepwalking and sleep-related eating disorders.
"Thus, while events of sleepwalking have occurred during treatment with Ambien, these instances cannot be systematically linked to the product," the company argued.
Ambien has treated sleeplessness in 14 billion patients worldwide since its introduction in 1993, Sanofi-Aventis said.