Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

Avoid with known allergy or sensitivity to melatonin or related products. Melatonin has been linked to allergic skin reactions and autoimmune hepatitis (liver inflammation caused by immune cells attacking the liver).

Side Effects and Warnings

Melatonin is likely safe when taken by mouth in commonly studied doses for up to three months, typically 1-20 milligrams. In children, melatonin is likely safe for long-term use in recommended doses.

Melatonin may cause abnormal heartbeat, aggression, amnesia, bedwetting (in children), body pain, changes in body temperature or feeling cold, changes in cholesterol levels, changes in the immune system, chest pain, confusion, decreased sperm count, delusions, disorientation, dizziness, eye damage or glaucoma (increased eye pressure), fatigue or irregular sleep-wake schedule, fogginess, hallucinations, headache, hormonal effects, hyperactivity, increased heart rate, increased seizure risk (particularly in children), inflammation, insomnia, irritability, mood changes, muscle control problems or weakness, musculoskeletal disorders, nightmares, nighttime awakening, poor sleep quality, psychotic symptoms, skin reactions (flushing, itching, painful lumps, paleness, and rash), sleepwalking, slow reaction time, stomach or intestinal disorders (changes in appetite, cramping, diarrhea, esophagus inflammation, nausea, odd taste in the mouth, stomach pain, and vomiting), vivid dreaming, weakness, worsened behavior, and yawning.

Melatonin may affect blood pressure. Caution is advised in people taking drugs, herbs, or supplements that affect blood pressure.

Melatonin may affect blood sugar levels. Caution is advised in people with diabetes or low blood sugar and those taking drugs, herbs, or supplements that affect blood sugar. Blood sugar levels may need to be monitored by a qualified healthcare professional, including a pharmacist, and medication adjustments may be necessary.

Melatonin may affect the risk of clotting. Caution is advised in people with bleeding or clotting disorders and those taking drugs that may affect bleeding. Dosing adjustments may be necessary.

Drowsiness or sedation may occur. Use caution in people who are driving or operating heavy machinery (including aircraft) and those taking depressants, stimulants, or sedatives.

Melatonin may interfere with the way the body processes certain drugs using the liver's cytochrome P450 enzyme system.

Use cautiously in people who have or are at risk of changes in hormone levels, eye disorders, frequently feeling cold, genital or urinary disorders (including children with a history of bedwetting), heart disease, hyperactivity, immune disorders, inflammatory disorders, mental disorders, muscle control problems, nervous system disorders, seizures, skin disorders, and stomach and intestinal problems.

Use cautiously in people taking agents that affect the immune system, anti-inflammatory agents, or hormonal agents.

Use cautiously in breastfeeding women, due to a lack of safety information.

Avoid in women who are pregnant or trying to get pregnant. Melatonin may decrease sex drive, increase the risk of developmental disorders, and reduce ovarian function.

Avoid in people with known allergy or sensitivity to melatonin or related products.

Pregnancy and Breastfeeding

Overall, there is a lack of high quality scientific evidence on the use of melatonin during pregnancy or breastfeeding.

Use cautiously in breastfeeding women, due to a lack of safety information.

Avoid in women who are pregnant or trying to get pregnant. Melatonin may decrease sex drive, increase the risk of developmental disorders, and reduce ovarian function.

This evidence-based monograph was prepared by The Natural Standard Research Collaboration

www.naturalstandard.com