The Sydney Morning Herald in Australia reported on 4 March 2007 that a woman who fell 30 metres to his death from a high-rise unit balcony may have been sleepwalking under the influence of Stilnox. The coverage prompted over 40 readers to contact the newspaper with their own accounts of Stilnox related automatism and the drug is now under review by the Adverse Drug Reactions Advisory Committee. (Wikipedia).
The updated warning released by the Therapeutic Goods Administration (TGA) now mentions less common side-effects as “rage reactions, worsened insomnia, confusion, agitation, hallucinations and other forms of unwanted behaviour”.
It also warns of “sleep walking, driving motor vehicles, preparing and eating food, making phone calls or having sexual intercourse” while asleep and on the drug. “People experiencing these effects have had no memory of the events,” the warning states. (The Sydney Morning Herald 28/11/2007).
Concerns are rising over the controversial sleeping drug Stilnox, with 300 callers swamping a consumer information line detailing dangerous side-effects, including sleep walking over high-rise balconies. Dr Moses, a pharmacist for 20 years, said she had never been so inundated with calls detailing adverse reactions relating to a single drug. (couriermail.com.au March 26, 2007).
Several sleeping pill users have moved to mount legal action after reports of bizarre and dangerous sleepwalking behaviour while taking the controversial drug Stilnox. The move comes as Stilnox complaints to the national drug hotline rose to 500, with fresh reports of sleepwalkers crashing cars, falling off balconies, smoking, painting and having sex after popping a pill. (theage.com.au, April 2, 2007).
The family of a Sydney woman, who died after plunging 20 metres from the Harbour Bridge, have blamed the controversial sleeping pill Stilnox for her death. Security footage shows 27-year-old Mairead Costigan walking groggily across the cycle path and climbing onto a ledge before she fell. (LIVENEWS.com.au).
Stilnox is sold as Ambien is the U.S.
“I have a number of clients who, the only way they get through the mediation or counselling sessions with their husbands is Ambien,” said a Manhattan divorce lawyer. “They knock themselves out and then they’re on automatic for the 45 minutes”.
At a recent party, actress Helen Hunt’s boyfriend, novelist Matthew Carnahan, remembered his Ambien-induced sleep: “You have strange dreams. If you try to stay awake, you make phone calls you don’t remember-it’s like living a horrible blackout.” (The New York Observer).
“The sleeping pill Ambien seems to unlock a primitive desire to eat in some patients, according to emerging medical case studies that describe how the drug’s users sometimes sleepwalk into their kitchens, claw through their refrigerators like animals and consume calories ranging into the thousands.” (The New York Times (March 14, 2006).
On a lighter note – from The New Yorker:
Sorpresa con Queso Ingredients: 7 bags Cheetos, 17 to 19 glasses tap water, 5 mg Ambien. Place Cheetos bags in cupboard. Take Ambien, fall asleep. Wait 2-3 hours, then sleepwalk to kitchen, tear cupboard doors off hinges in search of Cheetos…eat contents of all 7 bags… Icebox Melange…Take Ambien, fall asleep…sleepwalk to kitchen. Devour everything in refrigerator…(Paul Simms, Shouts & Murmurs, “The Ambien Cookbook,” The New Yorker, July 31, 2006, p. 34).
The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labelling to include stronger language concerning potential risks.
These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:
• Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
• Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.
The medications that are the focus of the revised labelling include the following 13 products:
Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)
FDA News, March 14, 2007. Accessed 20 February 2008.
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