NOTE THAT ALL INFORMATION IS FOR ADULTS SINCE NO FDA INDICATIONS FOR UNDER AGE 18 YEARS
NOTE THAT ADVERSE EFFECTS (Boxed Warnings, Warnings and Precautions, and Adverse Reactions) ARE A GENERAL SUMMARY OF FDA PACKAGE INSERT FOR ADULTS
Melatonin is a hormone produced in the pineal gland and is available over the counter (OTC) but not by prescription. This is a problem because the FDA does not monitor quality control of such OTC preparations; thus, the actual dose in an OTC melatonin preparation may not be the same as the dose on the label. Also, there is no FDA-approved Package Insert for melatonin. Melatonin appears to be effective in reducing time to sleep onset in adults (and, based on considerably less data, in children) for initial insomnia. This effect appears to last for days to weeks but not long-term. Thus, melatonin is not recommended for long-term use. It may be helpful for short-term alleviation of initial insomnia, which is relatively common following severe trauma, during an episode of depression, or following travel that crosses multiple time zones. Melatonin’s primary, if not only, adverse effect is sedation.