Posted on February 1, 2010.
Sleep Aids: Know the latest warnings on their labels? You would have been bombarded by television commercials and print ads on the wonders of the new sleeping pills. However, you could not cope with strong warnings either of their potential risks.
Several negative reports have appeared since the introduction of non-benzodiazepines (NBZ) class of drugs in the 1990s. These include the highly advertised Ambien, Lunesta, Sonata and Remeron. Although NBZs finally replaced the old class of drugs that the first-line treatment for insomnia, they seem just as likely to cause amnesia and erratic behavior. It seems that reports of sleep-eating and sleep driving on Ambien evoke problems of nearly 20 years with Halcion, which was banned in some countries.
Like last year, U.S. Food and Drug Administration (FDA) required manufacturers to include warnings not only strong in the labels but also to develop warning guides for distribution with virtually all hypnotic sedative hypnotics. These Guides are documents patient medication given to patients, families and caregivers when the drug is dispensed from sleeping.
"There are a number of prescription sleep aids available that are well tolerated and effective for many people," said Steven Galson, MD, MPH, director of the FDA for Drug Evaluation and Research. "However, after reviewing the available post marketing information side effects of these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."
The warnings are the following adverse events:
- Anaphylaxis (severe allergic reaction).
- Angioedema (swelling of face severe).
- Sleep at the wheel.
- Preparing and eating food while asleep.
- Making phone calls during sleep.
Allergic reactions may occur the first time the drug is taken sleeping.
Sleeping pills that are subject to the revised labeling include the 13 following products:
-Ambien/Ambien CR (Sanofi Aventis)
Butisol sodium (MedPointe Pharm HLC)
-Carbrital (Parke-Davis)
, Dalmane (Valeant Pharm)
, Doral (Questcor Pharma)
, Halcion (Pharmacia & Upjohn)
-Lunesta (Sepracor)
-Placidyl (Abbott)
-Prosoma (Abbott)
, Restoril (Tyco Healthcare)
-Rozerem (Takeda)
-Seconal (Lilly)
, Sonata (King Pharmaceuticals)
The problems that arise in the world have been. The World Health Organization (WHO) Collaborating Centre for International Drug Monitoring received 867 reports from 24 countries of people encountering amnesia, often coupled with confusion, agitation and other behavioral disorders, taking sleep medication news, such as Ambien and Lunesta, to March, 2007.
A graphic designer in New London, Wis., said she thought she was sleeping well on Ambien but woke to find her wrist broken, apparently in a fall while sleepwalking, she wrote to an exchange of e-mail. There were others who went on the binge eating as in the case of a woman who gained 23 kg more than seven months while taking zolpidem. "Only when it was discovered before an open refrigerator while asleep that the problem has been resolved," the report said.
Others brought their cars and engaged in activities other than their side does not remember. The Wall Street Journal reported the story of a woman who painted her front door in his sleep, and in some cases, people have had car accidents and even set fire to their homes while in the hypnotic state seems sometimes caused by drugs.
Although all sedative-hypnotic sleeping pills have these risks, there may be differences between the products in their frequency. For.