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Published on: March 11, 2023, 7:40 p.m.
Day of the Melatonin makers
  • Selling sleep? Companies produce synthetic Melatonin, which they claim, induce sleep; Pix courtesy: Pixabay

By Business India Editorial

"Sleep that soothes away all our worries. Sleep that puts each day to rest. Sleep that relieves the weary laborer and heals hurt minds," wrote Shakespeare in Macbeth. No wonder the market is flooding with Melatonin products.

Arround mid-January this year, Procter & Gamble (India), launched Vicks Zzzquil Natura, which contains Melatonin, a sleep inducer. P&G joins a long list of companies, which have introduced this product, the others being Himalaya Organics, Nutritionalab, Setu and Tata 1mg Healthcare Solutions, to name a few. 

Melatonin, a hormone made by the human body, is produced by animals and plants too. It is not a patentable product. Melatonin helps in inducing sleep. Products containing synthetic melatonin seek to replicate the function of the naturally produced melatonin.

Synthetic melatonin falls under the jurisdiction of The Food Safety & Standards Authority of India (FSSAI). The food regulator has classified this product as a nutraceutical, with a permitted range of 2-10 mg/day. 

No prescriptions needed  

In effect, this product is not a medicine and, hence, does not require a doctor’s prescription. A similar situation exists in the US, where it is considered a supplement (food) and the Food and Drug Administration (FDA) does not test what these supplements contain. It is one of the most popular products amongst kids. Countries like Singapore and Hong Kong too sell them without doctors’ prescription.

In Australia, there has been some relaxation since June 2021. For those above 55 years, they can buy this product without a doctor’s prescription. But, in countries like the UK, Canada and Japan, a doctor’s prescription is needed to buy this product.  And, in October last, the UK had even permitted children to have this product, subject to a doctor’s prescription.

P & G India is selling a sheet of 24 (the company calls them gummies, which has per unit cost of Rs18.71) for Rs449. For 30 (called capsules, with a per unit cost of Rs9.03), Tata 1mg Healthcare Solutions charges Rs271.  P&G India’s product has 2 mg of melatonin, while Tata 1mg Healthcare Solutions’ product has 10 mg of melatonin.

Clearly, there is a substantial difference in pricing and also the dosage of melatonin. While FSSAI has permitted a maximum range at 2-10 mg/day, P&G India and Tata 1mg are standing at the two ends of the spectrum, both having positioned the product as non-addictive. Both of them have also added vitamin B6 to it. 

  • A wide range of Melatonin products are available in the market

These companies make synthetic melatonin in chewable form, but there are others, like Arlak Biotech, Novus Life Sciences and NRD Enterprises, which have introduced melatonin in oral form too. It has to be sprayed under the tongue. NRD Enterprises, which claims that the product also contains L-Trytophan, sells them under the name Nutri Sharks, pricing a 30 ml bottle for Rs399. Arlak sells a similar sized spray for Rs401. It is an amino acid, which can have side effects. 

Consuming synthetic melatonin can have side effects. The most commonly reported side effects are drowsiness, dizziness, headache and nausea. In the US, it has been found that some companies mix serotonin with melatonin. Serotonin too is a hormone, which is produced by the human body. But synthetic serotonin, even in small quantities, can be harmful. L-Trytophan, an amino acid, is eventually converted into serotonin.

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