OmniRayn · Claims Substantiation Dossier · Confidential Work Product

Calm & Recovery

Language calibrated to the human evidence — the strongest honest claim each ingredient supports.
Basis: the human clinical literature, aggregated and evidence-graded, cite-or-refuse.  Prepared at the direction of counsel.
Each ingredient is graded on a ladder (A–E) and given the strongest honest phrasing its human evidence supports — never a pass/fail. This is an evidence assessment, not marketing copy; you select the final wording and own DSHEA/FTC compliance. This document is an informational work product prepared for review at the direction of counsel. It is provided for informational purposes only, is NOT legal, regulatory, or medical advice, and may contain errors or omissions. All findings and citations must be independently verified. Consult qualified regulatory counsel before relying on this document or making any labeling, marketing, or substantiation decision. Verify with counsel before use.

Melatonin — restful sleep

RUNG B · Moderate / mixed human evidence
“May help support restful sleep”also usable: “Research suggests it may support restful sleep”
Mechanism of action
Melatonin receptor agonist (agonist) · target: Melatonin receptor  source
avoid at this rung: shown, proven, clinically proven, significant, effective, boosts
27 supporting vs 16 contrary of 39 qualifying human study arm(s) · 70% tier-weighted support (weighting key: SR/MA ×3, RCT ×2, observational ×1) · studied 0.3–20 mg · label not disclosed · contrary systematic review present
TierDirectionDose (studied)CitationFinding
TIER-1unclearPMID:33417003Effect of melatonin supplementation on sleep quality: a systematic review and meta-analysis of randomized co
TIER-1supportingPMID:38888087Optimizing the Time and Dose of Melatonin as a Sleep-Promoting Drug: A Systematic Review of Randomized Contr
TIER-1supportingPMID:36179487Efficacy of melatonin for chronic insomnia: Systematic reviews and meta-analyses.
TIER-1unclearPMID:36584862Melatonin for sleep disorders in people with autism: Systematic review and meta-analysis.
TIER-2supportingPMID:39534260Effects of magnesium and potassium supplementation on insomnia and sleep hormones in patients with diabetes
TIER-2unclearPMID:22038497Effect of tart cherry juice (Prunus cerasus) on melatonin levels and enhanced sleep quality.
T-COcontraryPMID:33189083Pharmacotherapies for sleep disturbances in dementia.
T-COsupportingPMID:38781520Interventions for insomnia in cancer patients and survivors-a comprehensive systematic review and meta-analy
TIER-2contraryPMID:35220473Prophylactic melatonin for delirium in intensive care (Pro-MEDIC): a randomized controlled trial.
TIER-1supportingPMID:37434463Efficacy of melatonin and ramelteon for the acute and long-term management of insomnia disorder in adults: A
TIER-2supportingPMID:35436355High dose melatonin increases sleep duration during nighttime and daytime sleep episodes in older adults.
TIER-2supportingPMID:31982581Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Dis
86 qualifying human record(s) assessed. Contrary reviews are surfaced, not buried; language is graded to the evidence, never inflated.

Magnesium — restful sleep

RUNG A · Strong, consistent human evidence
“Supports restful sleep”also usable: “Helps maintain restful sleep”
Preclinical mechanism (preclinical)
“Magnesium and calcium modulate neuronal excitability and melatonin synthesis (enhancing GABAergic tone and enzyme activity) to promote slow-wave sleep.”  source
avoid at this rung: proven, clinically proven, significant, effective, treats, cures, reduces symptoms
10 supporting vs 5 contrary of 16 qualifying human study arm(s) · 73% tier-weighted support (weighting key: SR/MA ×3, RCT ×2, observational ×1) · studied 200–500 mg · label not disclosed
TierDirectionDose (studied)CitationFinding
TIER-1unclearPMID:35184264The Role of Magnesium in Sleep Health: a Systematic Review of Available Literature.
TIER-1supportingPMID:33865376Oral magnesium supplementation for insomnia in older adults: a Systematic Review & Meta-Analysis.
TIER-2supportingPMID:39534260Effects of magnesium and potassium supplementation on insomnia and sleep hormones in patients with diabetes
TIER-3supportingPMID:36354243Effect of short-term magnesium supplementation on anxiety, depression and sleep quality in patients after op
TIER-2contraryPMID:21199787Magnesium supplementation improves indicators of low magnesium status and inflammatory stress in adults olde
TIER-2unclearPMID:38745424The effects of melatonin and magnesium in a novel supplement delivery system on sleep scores, body compositi
TIER-2supportingPMID:35565828Effect of a Combination of Magnesium, B Vitamins, Rhodiola, and Green Tea (L-Theanine) on Chronically Stress
TIER-2unclearPMID:41680812Secondary prevention of leg cramps using compression stockings or magnesium supplements: a three-arm randomi
T-COunclearPMID:38738598Magnesium citrate monotherapy improves restless legs syndrome symptoms and multiple suggested immobilization
TIER-1unclearPMID:24280947Effect of magnesium therapy on nocturnal leg cramps: a systematic review of randomized controlled trials wit
T-COsupportingPMID:40151031Effects of Coenzyme Q10, Tryptophan, and Magnesium Supplementation on Fatigue in Patients with Fibromyalgia
T-COunclearPMID:35710238Predictive role of modifiable factors in stroke: an umbrella review.
37 qualifying human record(s) assessed. Contrary reviews are surfaced, not buried; language is graded to the evidence, never inflated.

Ashwagandha — a healthy response to everyday stress

RUNG A · Strong, consistent human evidence
“Supports a healthy response to everyday stress”also usable: “Helps maintain a healthy response to everyday stress”
Mechanism (human study)
“Ashwagandha supplementation appears to modulate key hormonal pathways, particularly cortisol and sex hormones.”  source
avoid at this rung: proven, clinically proven, significant, effective, treats, cures, reduces symptoms
4 supporting vs 0 contrary of 5 qualifying human study arm(s) · 100% tier-weighted support (weighting key: SR/MA ×3, RCT ×2, observational ×1) · studied 150–600 mg · label not disclosed
TierDirectionDose (studied)CitationFinding
TIER-1unclearPMID:39348746Effects of Ashwagandha (Withania Somnifera) on stress and anxiety: A systematic review and meta-analysis.
TIER-1unclearPMID:38140274Effects of Withania somnifera on Cortisol Levels in Stressed Human Subjects: A Systematic Review.
TIER-1supportingPMID:41740946Hormonal Modulation with Withania somnifera: Systematic Review and Meta-Analysis of Randomized-controlled Tr
TIER-1supportingPMID:40746175Dual impact of Ashwagandha: Significant cortisol reduction but no effects on perceived stress - A systematic
T-COunclearPMID:42105298Safety and efficacy of ashwagen (a standardized withania somnifera extract) in stress and anxiety with hyper
TIER-2supportingPMID:41815853A proprietary herbal extract of ashwagandha root for stress and anxiety in healthy adults: a randomized, dou
T-COsupportingPMID:41824889Efficacy and safety of Ashwagandha root extract sustained-release (AshwaSR) capsules in healthy adult, stres
T-COunclearPMID:37543151A blend of Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit extracts relieves
8 qualifying human record(s) assessed. Contrary reviews are surfaced, not buried; language is graded to the evidence, never inflated.
Literature studied this at the ranges shown. OmniRayn reports studied ranges and does not recommend a dose or issue a product-adequacy verdict.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Verify with counsel before use.