FDA REQUESTS SAFETY TRIALS FOR SLEEPING PILLS

The FDA has recommended that manufactures of sleep agents initiate clinical studies to determine the incidences of sleep-driving and other complex sleep behaviors that have been observed in postmarketing reports, the agency said March 14.

The recommendation is part of the agency's initiative to add warnings to labeling for 13 sleep agents based on adverse event reports, including reports of severe allergic reactions.

In noting that not one manufacturer has responded to the agency's request to undertake the studies, the FDA's Division of Neurology Director Russell Katz said, "It's easier for sponsors to adopt labeling than conduct trials, but we hope to be in discussions with sponsors to try and get them to do this. So we'll be working with them, but whether or not we will get any of these trials, I just don't know."

The FDA sent letters to manufacturers requesting the label warnings in December 2006, which should note "complex sleep-related behaviors, which may include sleep-driving, making phone calls and preparing and eating food (while asleep)."

In addition, the warnings should include a statement on "anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken," the agency said.

"Pretty much all [manufacturers] have agreed to the changes. The language that they adopt may be slightly different depending on whether they have a case reported of one of these events," Katz said.

The FDA first noticed a potential safety signal for severe allergic reactions following receipt of adverse event reports regarding Takeda's Rozerem (ramelteon) after the drug was on the market for a brief period, Katz said. The agency then studied the entire class of agents and concluded that the labels for all sedative-hypnotic sleep agents should be updated.

The agency first became aware of the sleep-driving safety signal last year following press reports. Other behaviors include eating, cooking, making telephone calls and engaging in sexual behavior during sleep.

( http://www.fdanews.com/did/6_53/ )