The Sleep Quandary: Is Melatonin Safe?

With all the recent issues with sleeping pills, Melatonin has shown to have a solid safety record.

Children
A review article in the March 1 issue of Natural Medicine Journal covers key studies on the use of melatonin in pediatrics, including its use for children’s sleep disorders, pediatric anesthesia, epilepsy and febrile seizures, adolescent idiopathic scoliosis, neonatal care, and the feeding of newborns.

Key Findings:
Melatonin use in children has been well-studied to date, and research suggests efficacy for several conditions. Melatonin has been most studied for its chronobiotic (sleep modulation) effects in various pediatric populations. No significant side effects of melatonin use in children have been reported.

Most interesting is the use of melatonin in children’s insomnia, a condition for which there are no approved pharmaceutical drugs. Most pediatricians and primary care physicians rely on behavioral treatments for insomnia, but a growing number of physicians are recommending melatonin. Administration of melatonin has been associated with faster sleep onset, as well as increased sleep duration. The greatest effect is seen with advancing sleep onset, and the most benefit is achieved when melatonin is dosed approximately 30–60 minutes before desired bedtime.

In the area of pediatric anesthesia, melatonin has been studied as an alternative to general anesthesia for diagnostic procedures such as MRI or brainstem audiology. It has also been studied as a premedication to general anesthesia for surgical procedures.

Most importantly, the body of evidence reviewed highly suggests that melatonin administration is very safe, even in the youngest children.

Melatonin Safe for Post-Menopausal Breast-Cancer Survivors
In the March issue of Cancer, Causes, and Control, researchers examined compliance with and the effects of melatonin supplementation on breast cancer biomarkers (estradiol, insulin-like growth factor I (IGF-1), insulin-like growth factor–binding protein 3 (IGFBP-3), and the IGF-1/IGFBP-3 ratio) in postmenopausal breast cancer survivors.

In a double-blind, placebo-controlled study, postmenopausal women with a prior history of stages 0-III breast cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned to either 3 mg oral melatonin or placebo daily for 4 months. Melatonin was well tolerated without any grade 3/4 toxicity. Overall, among postmenopausal women with a prior history of breast cancer, a 4-month course of 3 mg melatonin daily did not influence circulating estradiol, IGF-1, or IGFBP-3 levels.