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Drugs demanded to have new warning

0 CommentsPrint E-mail Global Times, September 19, 2010
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The national State Food and Drug Administration (SFDA) has ordered pharmaceutical companies to amend the directions they put on packages of sedative-hypnotic prescription drugs and notify people that the drugs may trigger adverse reactions including sleepwalking, sleep driving, sleep cooking and sleep eating.

Sedative-hypnotic drugs are mainly used to reduce tension and anxiety and help induce sleep.

"Based on the adverse reactions and assessment of the results, the SFDA decided to amend the current directions of sedative-hypnotic drugs to minimize the risks," the administration said on its website.

In addition, the administration also wants manufacturers to include any adverse reactions to packages that first time users may develop anaphylactic shock (shock caused by drug hyper-sensitiveness) or angioedema.

Sedative-hypnotics include zolpidem, amobarbital, triazolam, estazolam and flurazepam hydrochloride, according to the notice.

The SFDA requested each local drug and food administration office to inform the phar-maceutical enterprises about the amendment immediately and notify medical facilities.

"Unlike people from Western countries who would turn to a psychologist for help if they find themselves with insomnia, many Chinese tend to take sleeping pills right away," said Han Haiying, a specialist in neurology at Beijing Anding Hospital.

She told the Global Times that adverse reactions vary from person to person and it does not necessarily mean that everyone who takes the medicine would experience sleepwalking.

"Patients who often follow the dosage direction would not face any serious side effects," she said.

Jiang Qian, 46, an accountant from Tianjin who has taken sleeping pills for more than five years, told the Global Times that she hasn't suffered from any of side effects.

Han said if people take sleeping pills for a long time they usually develop dependence.

"Insomnia is a kind of mental illness, if people suffer from insomnia continuously, they should see a doctor." Han said.

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