Melatonin is a hormone that helps regulate sleep, but it is not a recommended treatment for chronic insomnia, according to information released on Jul. 23. Melatonin supplements lack an established dosage range and are not regulated by the Food and Drug Administration.
The American Academy of Sleep Medicine Practice Guidelines do not recommend melatonin as a treatment for insomnia due to limited data on its effectiveness and potential side effects. "Melatonin currently isn’t a recommended treatment for insomnia, according to the American Academy of Sleep Medicine (AASM) Practice Guidelines. That’s because there’s generally a lack of data regarding effectiveness and potential side effects," the source said.
There is an FDA-approved melatonin receptor agonist called ramelteon (Rozerem), which binds and activates melatonin receptors and has shown some benefits for insomnia. Ramelteon is available only by prescription. Melatonin does have stronger evidence supporting its use in certain circadian rhythm disorders and in children with neurodevelopmental disorders; specifically, it may be recommended three to six hours before bed for delayed circadian rhythm disorders.
Since melatonin is classified as a dietary supplement, it can be purchased over the counter without a prescription. However, concentrations and dosages in these formulations may vary due to less stringent regulation by the FDA. The article said, "It’s important to know that there isn’t a firmly established dosage range for insomnia... These preparations may also contain other additives that have their own potential side effects." Other supplements such as tryptophan and valerian are also not recommended treatments for insomnia under current guidelines.
The article advises consulting with a doctor before using any sleep supplements due to possible risks of side effects or interactions with prescribed medications. Psychological and behavioral treatments such as cognitive behavioral therapy are currently considered the best treatments for insomnia.
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