Why isn't melatonin considered a drug? And should it be?

Key Points:

• Melatonin supplements are widely available in U.S. pharmacies as sleep aids, but experts warn that labeling can be misleading and the products are not strictly regulated like pharmaceuticals, leading to inconsistent dosages and limited safety information.
• The FDA classifies melatonin as a dietary supplement, unlike the U.K. and Australia where it is treated as a medication, resulting in less oversight and concerns about misuse, especially among children who often receive high doses without clear long-term safety data.
• Research indicates melatonin supplements often contain much higher doses than the body naturally produces, which can disrupt the circadian rhythm if taken improperly, causing side effects like daytime drowsiness, irritability, and insomnia.
• Calls to poison control centers for melatonin-related incidents in young children have increased, sometimes involving severe symptoms, partly due to accidental ingestion and potentially harmful additives like serotonin in some products.
• Some experts advocate for reclassifying melatonin as an over-the-counter drug to ensure accurate dosing and safety labeling, but industry resistance and concerns about reduced access and increased costs make this unlikely in the near future.