FDA warns of sedative hypnotic effects.   ABC World News (3/14, story 5, 2:15, Gibson) reported, "We're going to turn, next, to some of the most widely-used and widely-advertised drugs in America, prescription sleeping pills. More than 35-million prescriptions were written for sleep aids in 2005. That represents a 55-percent increase in just four years." ABC (Stark) added, "The ads promise a restful night of sleep. But the FDA is warning the popular sleep aids can cause severe reactions and sleep walking -- everything from cooking meals, to making phone calls, all the way in a drug-induced sleep." Dr. Sandra Kweder deputy director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research, was shown saying, "One of the most frequent types of reports that we've seen is something that people call 'sleep driving,' where people, during the night, get out of bed and drive their car and actually go somewhere." Stark continued, "Drug manufacturers say patients can lower their risk, by sticking to the recommended dose and avoiding alcohol. But the FDA wants the companies to do additional studies to determine how common the side-effects are."
      The CBS Evening News (3/14, story 10, :25, Couric) reported, "The FDA today ordered tougher warning labels for sleeping pills, including [Sanofi Aventis's] Ambien (zoldipem tartrate) and [Sepracor's] Lunesta (eszopiclone). The agency wants users to know about two potential side effects -- severe allergic reactions and something called sleep driving."
      NBC Nightly News (3/14, lead story, 2:45, Brown) reported, "Doctors have written tens of millions of prescriptions for drugs like Ambien and Lunesta, and while the side effects are rare, they are serious." NBC (Costello) added, "The FDA says those side effects can include sleep driving, cooking while asleep...and there's also a very real concern about serious allergic reactions. And, they are among the most heavily advertised and prescribed medications in America. In 2005, doctors wrote 42-million prescriptions for sleeping pills, 26-million for Ambien, 3.2-million for Lunesta. For years, patients complained the medications caused strange side effects. ... Now the FDA wants full brochures inside the box warning doctors and patients of the risks." The Wall Street Journal (3/15, D9, Mathews, Dooren) adds "The new language will go in the 'warnings' and 'precautions' sections of the drugs' labels, rather than in a black box at the top, where the most serious safety concerns are placed."
      USA Today (3/15, Rubin) reports, "Ambien and other popular sleep aids will now carry warnings about risks of 'complex behaviors' such as driving or preparing food when not fully awake and potentially lethal allergic reactions, the FDA said Wednesday. Makers of the 13 affected drugs will begin sending letters to doctors this week to alert them to these risks, and the companies have until May to submit consumer-friendly 'Medication Guides' to the FDA, Russell Katz, M.D., director of the FDA division that reviews neurology drugs, said at a news conference. After the FDA approves the leaflets, they are to be distributed with every filled prescription."
      HealthDay (3/15, Reinberg) lists the 13 drugs, which are Ambien, Medpointe Pharm's Butisol (butabarbital), Parke-Davis's Carbrital (pentobarbital and carbromal), Valeant Pharm's Dalmane (flurazepam hydrochloride), Questcor Pharm's Doral (quazepam), Pharmacia & Upjohn's Halcion (triazolam), Lunesta, Placidyl (ethchlorvynol), Abbott's Prosom (estazolam); Tyco Healthcare's Restoril (temazepam), Takeda's Rozerem (ramelteon), Eli Lilly's Seconal (secobarbital), and King Pharmaceuticals's Sonata (zaleplon).
      The New York Times (3/15, Saul) reports "The FDA review was prompted, in part, by queries to the agency from the New York Times last year, after some users of the most widely prescribed drug, Ambien, started complaining online and to their doctors about unusual reactions ranging from fairly benign sleepwalking episodes to hallucinations, violent outbursts, nocturnal binge eating and -- most troubling of all -- driving while asleep. ... The reports gained credence from scientific studies. A forensic toxicologist in Wisconsin, Laura J. Liddicoat, gave a presentation at a national meeting on six instances of Ambien-impaired driving." The Los Angeles Times /AP (3/15) reports that the "FDA wouldn't say exactly how many cases of sleep-driving it uncovered, or if it knew of any car crashes."
      Bloomberg (3/15, Larkin, Zimm) quotes Michael Silber, president of the American Academy of Sleep Medicine, who said, "In an altered conscious state people perform acts with little memory of them afterwards. We don't know how frequent the behaviors are, but they are potentially serious and patients don't always relate them to the drug.'' The UPI (3/15) and the Washington Post /AP (3/15, A11) also report the FDA's announcement.
      Medpage Today (3/15, Peck) notes that Dr. Katz "repeatedly emphasized that the allergic reactions, including anaphylaxis and angioedema, and the complex sleep-related behaviors, are 'rare by any definition' and he said the FDA has not received any reports of death associated with either side effect."