What is the risk of liver and kidney toxicity associated with melatonin (Sleepasil) supplementation?

From the Guidelines

Melatonin and Sleepasil are generally considered safe for most people when used as directed, with minimal risk of liver or kidney toxicity. Melatonin is a hormone naturally produced by the body that regulates sleep cycles, and when taken as a supplement, it's typically processed efficiently by the liver without causing damage 1. Sleepasil is a natural sleep supplement containing various ingredients including melatonin, valerian root, and other herbs. Neither melatonin nor Sleepasil has been strongly associated with liver or kidney damage when used at recommended dosages for short periods. However, individuals with pre-existing liver or kidney conditions should consult their healthcare provider before using these supplements.

Some key points to consider:

• A review by the National Academy of Sciences stated that short-term use of ≤ 10 mg/daily appears to be safe in healthy adults, but recommended caution in children/adolescents and women of reproductive age 1.
• Adverse effects such as headaches, somnolence, hypotension, hypertension, gastrointestinal upset, and exacerbation of alopecia areata have been reported at higher melatonin doses in healthy adults 1.
• Long-term use of any supplement without medical supervision is not recommended.
• If you experience symptoms like unusual fatigue, yellowing of skin or eyes, dark urine, or pain in your abdomen while taking these supplements, discontinue use and seek medical attention immediately.
• The body naturally clears melatonin efficiently, and most people can take standard doses (0.5-5mg) without concern for organ toxicity, though the lowest effective dose is always preferable 1.

It's essential to note that the quality of evidence from the analyses of the accepted/reviewed studies was LOW, and data regarding the sleep/circadian-related effects of melatonin were contradictory 1. Nevertheless, clinical experience suggests frequent acceptance of this treatment among adults versus no treatment. Therefore, it is crucial to weigh the benefits and harms of melatonin use, especially in pediatric/adolescent populations, and to consult a healthcare provider before using these supplements.

From the Research

Melatonin and Sleepasil: Liver and Kidney Toxicity

• There is limited research on the specific topic of melatonin Sleepasil liver and kidney toxicity, however, several studies have investigated the effects of melatonin on liver and kidney function.
• A study published in 2019 2 found that melatonin has a protective role in early-stage and end-stage liver cirrhosis, inhibiting oxidation, inflammation, and hepatocyte apoptosis.
• Another study from 2012 3 discussed the therapeutic benefits of melatonin treatment in sleep disorders related to chronic kidney disease, including its effects on blood pressure alterations and oxidative stress.
• A systematic review from 2019 4 assessed the adverse events associated with melatonin treatment for sleep disorders and found that melatonin was generally regarded as safe and well-tolerated, with few serious or clinically significant adverse events reported.
• Additionally, a review from 2017 5 highlighted the therapeutic functions of melatonin in sleep disorders, including its ability to synchronize circadian rhythms and improve sleep quality, with no obvious short- or long-term adverse effects.

Liver Toxicity

• The study from 2019 2 suggested that melatonin may have a protective effect against liver injury by inhibiting oxidation and inflammation, and may be a potential agent for reversing liver cirrhosis in its early stage.
• However, there is limited research on the specific topic of melatonin Sleepasil liver toxicity, and more studies are needed to fully understand its effects.

Kidney Toxicity

• The study from 2012 3 found that melatonin treatment may have beneficial effects on blood pressure alterations and oxidative stress in patients with chronic kidney disease.
• However, there is limited research on the specific topic of melatonin Sleepasil kidney toxicity, and more studies are needed to fully understand its effects.
• A review from 2015 6 discussed the physiological effects of melatonin in humans, including its role in regulating circadian rhythms and sleep-wake cycles, but did not specifically address kidney toxicity.