Melatonin Products with USP Verification Mark
Melatonin products with USP (United States Pharmacopeia) verification mark are recommended for consistent dosing and reliable formulation, as these have been confirmed to contain the amounts of melatonin stated on the label. 1
Why USP Verification Matters
The USP verification is particularly important for melatonin because:
- Melatonin is classified as a dietary supplement in the US, not regulated by the FDA, raising concerns about purity and reliability of stated doses 1
- Studies have shown significant quality issues with non-verified melatonin products, including:
- Failure to disintegrate and dissolve properly
- Excessive friability (tendency to crumble)
- Inconsistent hardness
- Poor formulation and quality control 2
- For conditions like REM sleep behavior disorder, the American Academy of Sleep Medicine specifically notes that different formulations could lead to varying efficacy between melatonin brands 1
Available USP-Verified Melatonin Products
While specific brand names may change over time, consumers should look for the USP Verification Mark on the label. This mark indicates the product:
- Contains the ingredients listed on the label
- Contains the declared amount of ingredients
- Will break down and release into the body within a specified timeframe
- Has been made according to FDA good manufacturing practices
- Is free from harmful levels of contaminants
Clinical Considerations When Using Melatonin
- Melatonin is generally considered safe for short-term use 1, 3
- The Mayo Clinic Proceedings guideline recommends continuing melatonin even perioperatively 1
- Low to moderate dosages (approximately 5-6 mg daily or less) appear safe for most adults 3
- Immediate-release melatonin has shown clinically significant improvements for conditions like REM sleep behavior disorder 1
Common Dosing Considerations
- For sleep onset issues: 0.5-5mg taken close to target bedtime (10pm-midnight) 4
- For circadian rhythm disorders: Timing of dose is critical - taking it at the wrong time can cause sleepiness and delay adaptation 4
- For REM sleep behavior disorder: Immediate-release formulations are recommended 1
Potential Side Effects and Precautions
- Common side effects include daytime sleepiness, headache, trouble thinking, and nausea 1
- Special caution advised for:
When selecting a melatonin product, the USP verification mark provides the most reliable assurance of quality and consistent dosing, which is particularly important given the lack of FDA regulation of melatonin as a dietary supplement.