Melatonin with L-Theanine Sleep Tablets

This tablet carries two unrelated chemistries in one unit. Melatonin (CAS 73-31-4, C13H16N2O2, 232.28 g/mol) is an indoleamine made by chemical synthesis, an off-white to pale yellow crystalline powder melting near 117 degrees C. L-theanine (CAS 3081-61-6, C7H14N2O3, 174.20 g/mol) is (2S)-2-amino-5-(ethylamino)-5-oxopentanoic acid, the N5-ethyl amide of L-glutamine, a water-soluble amino acid that makes up roughly 1 to 2 per cent of the dry weight of green tea leaf. They behave differently in the press: melatonin is a microgram-to-milligram active that needs tight blend uniformity, while the theanine load is what actually sets tablet weight. The standard build is 3 mg melatonin with 200 mg L-theanine, and Thovek runs melatonin from 0.5 to 5 mg against L-theanine from 100 to 250 mg to the buyer's brief. The L-theanine is fermentation grade as standard, produced enzymatically from L-glutamine and ethylamine, which makes it vegan and caffeine-free by route; a Camellia sinensis-derived grade is available where the brand wants a tea provenance story, in which case a caffeine limit is written into the specification before the first lot ships. Only the L-enantiomer is accepted at goods-in, confirmed by optical rotation reported at about +8 degrees (c = 5, water); racemic DL-theanine is a known cheap substitute and is rejected. Each active is assayed on its own validated HPLC method and both figures appear on the lot certificate. Neither active brings a milk, egg, soy, fish, crustacean, gluten, peanut or tree-nut allergen with it, and the finished tablet is vegan when built on fermentation-derived theanine with vegetable-source magnesium stearate; a gelatin-containing coating or a bovine-tallow stearate would break that, so the excipient origins are locked in writing at brief. Note that the two actives do not share a regulatory position. L-theanine has been the subject of US GRAS notifications, including one covering use at up to 250 mg per serving, and Japan has permitted it in foods other than infant food since 1964. Melatonin is a dietary supplement in the United States but a licensed medicine in prolonged-release form in the EU, Israel, Australia and parts of Asia. The combination product therefore has to clear the stricter of the two positions in each destination, and on-pack wording remains the brand owner's responsibility.