Doctors are warning parents that the dietary supplement melatonin should not be given to children as a sleep aide without careful consultation with a doctor or healthcare practitioner because the supplement has not been clinically proven to be a safe sleep agent in healthy children.
Melatonin is a hormone that is secreted in the brain. It is also a naturally occurring compound in plants and microbes. Manufactured melatonin supplements are thought to help people sleep through the night, and thus are an attractive option for parents whose children have trouble with sleep.
Melatonin supplements have been available over-the-counter in the United States since the mid-1990s. In many other countries, however, the sale of melatonin is prohibited or requires a prescription.
In the U.S., because the product is sold as a dietary supplement and not a drug, Food and Drug Administration (FDA) regulations that apply to medications are not applicable to melatonin. However, in June 2010, the FDA established new rules requiring companies that produce dietary supplement to comply with “current good manufacturing practices” with “controls that result in a consistent product free of contamination, with accurate labeling.” The industry is also required to report any adverse events associated with their dietary supplements.
Melatonin may be readily available in the United States, but medical professionals warn that the product does have side effects that may be more harmful to children. The product has been associated with vivid dreams and nightmares and can cause grogginess even hours after waking.
“It’s possibly thought to affect growth, to affect sexual development and puberty and a lot of other effects,” Dr. Johnson-Arbor told NBC Connecticut. “It is a hormone and it definitely can have these severe interactions that you might not think of just looking at the pill on the counter and buying it over the counter thinking it is safe.
While melatonin has been clinically proven to help children with specific disabilities such as autism, it has not yet been proven safe for children without disabilities. Instead, Dr. Tom Fromson told NBC Connecticut, parents should examine bedtime routines as well as a child’s lifestyle, diet and exercise.
“As a routine medication to help a child sleep, I think I should first have a better understanding of why a child is having trouble sleeping,” he said.