Melatonin Safety Concerns and Dietary Supplements

Melatonin Safety Concerns and Dietary Supplements
Danica Grover, PharmD
Essentia Health

Per a JAMA article by Kuehn, insomnia rates have risen over the past 20 years with nearly one third of US adults experiencing it. With rising rates in sleep difficulties and poor sleep hygiene, many people have turned to melatonin as a quick fix. Recently, melatonin use has become more prevalent among adult and pediatric patients. The 2017 American Academy of Sleep Medicines (AASM) practice guidelines suggest to not use melatonin in adults for insomnia. AASM recommends cognitive behavioral therapy for insomnia as first-line therapy in children and adults. Although melatonin is generally well tolerated and safe, it doesn’t come without risks. There are very few long-term safety studies performed on melatonin. Additionally, the commonly used high doses of 5 mg or more may increase the risk of adverse effects. Common side effects include fatigue, dizziness, headache, and daytime sleepiness. An article by Lelak et al. reported that US poison control centers have noticed a 530% increase in calls about children ingesting melatonin between 2012 and 2021. Many of the melatonin products formulated as gummies are highly attractive to children and lack childproof packaging; however, melatonin is still a drug and should be kept out of the reach of children. Kuehn’s article mentions that for children, medications or supplements such as melatonin for sleep may not be appropriate and may not address underlying issues that are typically behavioral.

One resource that may help address the increasing safety concerns of melatonin and other supplements is a new education initiative developed by the US Food and Drug Administration (FDA). “Supplement Your Knowledge” is a program that strives towards educating consumers, educators, and healthcare professionals about dietary supplements. The website provides patient- and educator-friendly fact sheets and infographics that can be downloaded in English and Spanish. There are educational videos that provide overviews of dietary supplements, dietary supplement interactions with medications, adverse effects and more. This website can be a quick and easy resource for patients with reliable information. Additionally, the website serves as an opportunity for free continuing medical education program for healthcare professionals.


  1. Kuehn, BM. Climbing Melatonin Use for Insomnia Raises Safety Concerns. JAMA. 2022;328(7):605-607. doi: 10.1001/jama.2022.11506.
  2. Edinger, JD, Arnedt, JT, Bertisch, SM, Carney, CE, Harrington, JJ, Lichstein, KL, Martin, JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. Journal of Clinical Sleep Medicine, 17(2), 255-262.
  3. Lelak K, Vohra V, Neuman MI, Toce MS, Sethuraman U. Pediatric Melatonin Ingestions — United States, 2012–2021. MMWR Morb Mortal Wkly Rep 2022;71:725–729. doi: 10.15585/mmwr.mm7122a1
  4. United States Food and Drug Administration. Supplement Your Knowledge. 2022. Updated May 25, 2022. Accessed September 24, 2022.