Melatonin Tablet

Melatonin Tablets are sleep supplements that provide melatonin, the hormone the body naturally produces when it gets dark. Melatonin tells the body it is time to sleep, and supplements are used to help people fall asleep faster and to reduce the effects of jet lag.

Arizone International manufactures and supplies Melatonin Tablets in several strengths and formats, for sleep product brands and private label businesses, subject to the regulations of each market.

The Body's Night Signal

Melatonin is made by the pineal gland, a small gland deep in the brain. As light fades in the evening, melatonin levels rise, and they fall again in the morning. This rhythm helps set the body clock. Bright screens and artificial light at night, shift work and travel across time zones can disrupt this natural rhythm. Melatonin levels also tend to fall with age, which may partly explain why older adults often sleep less deeply.

Melatonin was first isolated in 1958 by an American dermatologist, Aaron Lerner, who was studying skin colour. Research on sleep came later.

Formats and Strengths

• Standard TabletsCommonly 1 mg, 3 mg, 5 mg and 10 mg, depending on market rules.
• Low-Dose Tablets0.3 mg to 0.5 mg, closer to natural levels, preferred in some research.
• Sublingual and Fast-Melt TabletsDissolve under the tongue for quick onset.
• Extended-Release TabletsRelease melatonin slowly to support staying asleep.
• Combination TabletsWith L-theanine, magnesium, chamomile or lemon balm.

Applications

• Occasional sleeplessness supplements
• Jet lag and travel sleep products
• Shift work sleep support
• Sleep blends with calming herbs and minerals
• Private label sleep ranges

Melatonin Regulations by Country

Melatonin is treated very differently around the world. It can be a food supplement in one country and a prescription-only medicine in the next, so the market decides the dose, format and even whether the product can be sold. Below is a general overview of the main export markets:

• IndiaMelatonin appears in both medicine and nutraceutical categories. Depending on dose and claims, products may fall under FSSAI's nutraceutical regulations or under CDSCO as a drug, so the route should be confirmed before launch.
• United StatesSold as a dietary supplement under DSHEA, widely available over the counter in strengths from 0.5 mg to 10 mg.
• CanadaSold as a licensed Natural Health Product. Each product needs a Natural Product Number (NPN) from Health Canada before sale.
• United KingdomA prescription-only medicine regulated by the MHRA. It cannot be sold as a food supplement.
• European UnionNo single rule. Some member states, such as France, Italy and Spain, allow low-dose melatonin in food supplements, while others, such as Denmark and the Czech Republic, treat it only as a medicine. Prolonged-release melatonin is generally a prescription medicine. The EU has authorised health claims for melatonin on falling asleep and jet lag at specific daily amounts.
• AustraliaRegulated by the TGA as a medicine, not a supplement. Most melatonin is prescription-only, with limited pharmacist-only access for certain prolonged-release products for older adults.
• New ZealandHistorically a prescription medicine. It has been reclassified so that adults can buy it from pharmacies without a prescription, while it remains prescription-only for children and teenagers.
• SingaporeRegulated by the HSA as a prescription-only therapeutic product.
• JapanTreated as a pharmaceutical ingredient rather than a food, with very limited approved products. Import and sale rules should be checked carefully.
• Saudi Arabia and UAESupplements must be registered with the SFDA in Saudi Arabia and with the relevant UAE authorities before sale. The SFDA has also issued public warnings against excessive melatonin use.

Regulations change over time, so this overview is a guide only. Before each export order, we check the latest rules with our client for the destination country and help set the correct dose, label wording and product category.

Safety Notes

Melatonin can cause drowsiness, so users should not drive or operate machinery after taking it. It may cause headaches, dizziness or vivid dreams. It can interact with blood thinners, sedatives, blood pressure medicines, diabetes medicines and immunosuppressants. It is not recommended for pregnant or breastfeeding women, and it should be given to children only on medical advice. Long-term use should be discussed with a doctor.

Quality Considerations

• Melatonin assay and content uniformity by HPLC, which is critical for low-dose tablets
• Purity and impurity profile
• Release profile for extended-release tablets
• Heavy metals and microbiology
• Batch consistency and Certificate of Analysis

Why Choose Arizone International?

We are an India-based manufacturer and exporter of nutraceutical products. We offer private label and contract manufacturing of Melatonin Tablets and sleep blends, with strict dose control and support on regulatory positioning.

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