Melatonin & Vitamin B6

Melatonin and vitamin B6 reference formula at example amounts of 5 mg and 10 mg per serving, developed as a tablet or capsule.

Melatonin & Vitamin B6 is a reference formula for brands building a two-ingredient evening product that pairs melatonin with vitamin B6, around example amounts of 5 mg of melatonin and 10 mg of vitamin B6 per serving. The brand sets the final amounts for its market. Reference labels span melatonin from 1 to 10 mg and vitamin B6 from 335 mcg to 25 mg, so the example is a starting point rather than a standard.

Tablet is the lead format because a small, low-dose unit is typical for this pair, and capsule follows. The work centers on blending a few milligrams of two actives evenly into a unit that weighs a hundred times more.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Melatonin5 mg (example amount)Melatonin powder, synthetic, specified on a declared-weight basis; 5 mg per servingTime-release melatonin granules, if a sustained profile is chosen, with their own specification
Vitamin B610 mg (example amount)Pyridoxine hydrochloride, specified as pyridoxine; 10 mg vitamin B6 per servingPyridoxal 5′-phosphate, with the input recalculated for the form

Amounts are stated as mg of melatonin and mg of vitamin B6 as pyridoxine. Melatonin is C13H16N2O2, 232.28 g/mol (PubChem CID 896). Pyridoxine hydrochloride (C8H12ClNO3, 205.64 g/mol; PubChem CID 6019) weighs more than pyridoxine (C8H11NO3, 169.18 g/mol; PubChem CID 1054), so 10 mg of vitamin B6 as pyridoxine needs about 12.2 mg of the hydrochloride (10 × 205.64 ÷ 169.18).

Intended Benefits & Formula Rationale

This formula is designed for products positioned around evening routines and sleep nutrition. Melatonin is the lead ingredient and vitamin B6 is included as the partner vitamin.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Evening and sleep routineMelatoninA meta-analysis of 19 placebo-controlled studies in 1,683 subjects with primary sleep disorders reports that melatonin reduced sleep latency by a weighted mean difference of 7.06 minutes (95% CI 4.37 to 9.75) compared with placebo [1]. Evidence: Referenced
Vitamin B6 as a cofactorVitamin B6A review states that only pyridoxal 5′-phosphate functions as a cofactor for enzymes, and that pathways reliant on it include amino acid and neurotransmitter metabolism [2]. Evidence: Referenced

The amounts are examples. The studies in [1] and [2] cover melatonin and vitamin B6 separately and do not test this combination, so any claim on a finished product is reviewed for each market.

Available Formats

Reference labels are mostly tablets, with a smaller group of capsules; these two formats are developed here.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Tablet1 tabletMelatonin 5 mg, vitamin B6 10 mg60 or 120 tabletsDicalcium phosphate, cellulose, silica, magnesium stearate, stearic acidLead format; small compressed unit
Capsule1 capsuleMelatonin 5 mg, vitamin B6 10 mg60 or 120 capsulesVegetable capsule shell, cellulose, flow agentBlended fill without compression

Raw Material Input & Fill (Design Estimate)

Design estimates. Melatonin is taken at its declared weight and vitamin B6 is supplied as pyridoxine hydrochloride at 100% purity, so each unit needs 5 mg of melatonin and about 12.2 mg of the hydrochloride.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
TabletMelatonin 5 mg, pyridoxine hydrochloride 12.2 mg200 mg tablet weight182.8 mgContent uniformity of both actives, hardness, disintegration, assay
CapsuleMelatonin 5 mg, pyridoxine hydrochloride 12.2 mg200 mg per capsule182.8 mgBlend uniformity, fill weight variation, assay

Gummy, liquid and sublingual versions are separate projects, because melatonin in those systems brings its own dissolution and taste work.

Formulation Considerations

Low-dose uniformity. Five milligrams of melatonin in a 200 mg unit is a 2.5% blend. Geometric dilution or a premix, particle size control and a content uniformity test on units from the start, middle and end of the run decide whether each unit delivers the stated amount.
Assay against the label. A research letter measured the quantity of melatonin and CBD in melatonin gummies sold in the US [3]; assaying finished units against the label amount is built into the pilot run for this formula.
Vitamin B6 form and stability. Pyridoxine hydrochloride is stable in a dry blend but is sensitive to light and moisture over time. The pack, a desiccant and a stability assay of both actives are part of the plan.
Dose and market limits. Melatonin is regulated differently from market to market, and some markets cap it by serving. The 5 mg example sits inside the range of the reference labels, and the allowed amount is checked for each sales market before the formula is fixed.

Customization Options

Brands adjust the amounts, the B6 form, the format and the add-ons.

ParameterRangeNote
Melatonin per serving0.5, 1, 3, 5 or 10 mgExamples for the brand; the allowed amount depends on the market
Vitamin B6 per serving1, 10 or 25 mgExamples for the brand; input recalculated for the form
FormatTablet or capsuleGummy, liquid and sublingual are separate projects
ReleaseImmediate or time-releaseA time-release granule changes the tablet design
Add-onsMagnesium, L-theanineA third active shifts the tablet weight and the blend plan

The pilot run confirms content uniformity of both actives at the chosen amounts, tablet hardness and disintegration, and the assay after a short stability hold.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (Melatonin 5 mg + Vitamin B6 10 mg on the label of CF005842; example DSLD labels 35632, 63593, 65932). The label names the two ingredients by name; pyridoxine hydrochloride is set as the vitamin B6 form.
SpecificationSet in formulationMelatonin powder at 5 mg and pyridoxine hydrochloride at 10 mg as pyridoxine per serving; assays, moisture, microbial and heavy-metal limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Ferracioli-Oda E, Qawasmi A, Bloch MH. Meta-analysis: melatonin for the treatment of primary sleep disorders. PLoS One. 2013;8(5):e63773. DOI · PubMed<br>[2] Wilson MP, Plecko B, Mills PB, et al. Disorders affecting vitamin B6 metabolism. J Inherit Metab Dis. 2019;42(4):629-646. DOI · PubMed<br>[3] Cohen PA, Avula B, Wang YH, et al. Quantity of Melatonin and CBD in Melatonin Gummies Sold in the US. JAMA. 2023;329(16):1401-1402. DOI · PubMed

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