Ministry warns on sale of sleep drug melatonin

The Ministry of Health and Welfare yesterday warned that melatonin, which is used to treat sleeping disorders, has never been approved in the nation, so purchasing it abroad and selling it in Taiwan is against the law.

According to a survey by the Taiwan Society of Sleep Medicine, about one in five, or 20.2 percent, of Taiwanese suffer from chronic sleep disorder.

Statistics released by the Food and Drug Administration (FDA) in February also showed that a total of 339 million sleeping pills were consumed in Taiwan in 2014.

While many people are worried about the side effects of taking sleeping pills regularly, such as dizziness or lightheadedness, prolonged drowsiness, headaches, gastrointestinal problems, severe allergic reactions or daytime memory and performance problems, some turn to melatonin to help them deal with insomnia.

In some countries like the US, melatonin is considered a dietary supplement and can be purchased over the counter. Some use it to adjust the body’s internal clock, such as when suffering from jet lag or shift-work disorder.

However, Chi Jo-feng , a senior technical specialist at the Food and Drug Administration, said melatonin has been listed as a controlled substance in Taiwan since 1996.

No local pharmaceutical company has ever applied for a drug manufacturing license, so production or selling of melatonin is illegal in the nation, Chi said.

According to the Pharmaceutical Affairs Act ), people who import or sell illegal drugs, such as melatonin, can face up to 10 years in prison or a fine of up to NT$50 million (US$1.55 million), the ministry said.

People can purchase melatonin for personal use, but are allowed to bring in only 12 bottles, it said, adding that selling them is strictly against the law.

“Taking melatonin regularly for an extended period can change the natural production and release of melatonin in the body,” Lin Chia-mo, chief director of the Sleep Research Center at Shin Kong Memorial Hospital, said yesterday, adding that the dosage and ingredients of these products are not universal and could be confusing to users.

Moreover, overseas studies have shown that a high dosage of melatonin can cause possible side effects, including nausea, vomiting, daytime sleepiness or even affect fertility.

Source: Taipei Times