Product Information Sheet
Hedonia®
February 26, 2026 – Update
A medical food for the clinical dietary
management of depression.
DESCRIPTION
Each capsule contains:
Dietary Ingredients:
- EACH CAPSULE CONTAINS A TOTAL OF 450mg OF OMEGATEX8000 OMEGA-3 TRIGLYCERIDES OF WHICH EPA IS 360mg
- 81mg OTHER OMEGA-3 FATTY ACIDS
- 9mg DHA
- 300mg OF ADONAT PREMIUM SAMe STABILIZED POWDER
- 5.0mg OF L-METHYLFOLATE GLUCOSAMINE AS QUATREFOLIC.
Other Ingredients:
- Purified Omega 3 Fish Oil as Omegatex8000
- S-Adenosylmethionine (SAMe) as Adonat
- L-Methylfolate Glucosamine as Quatrefolic
- Gellum gum
- Hypromellose
- Aerosil 200F
- Sodium Copper Chlorophyllin.
INDICATIONS AND USAGE CLINICAL DIETARY MANAGEMENT OF MAJOR DEPRESSIVE DISORDER:
Hedonia® is formulated to meet the distinctive nutritional requirement of individuals who have suboptimal L-Methylfolate levels in the cerebrospinal fluid, plasma, and/or red blood cells and have major depressive disorder (MDD). Omega-3 EPA S-Adenosylmethionine (SAMe)
Please consult your medical provider for the use of Hedonia® concomitant to antidepressant drugs.
Hedonia® is a medical food for use under the supervision of a physician for the dietary management of depressive disorder (MDD) and is specially formulated to provide the distinctive nutritional requirements of this
condition.
It is recommended that you check with your doctor before taking or adding Hedonia® to your daily routine. If you are pregnant, nursing, diagnosed with bipolar disorder, and/or taking MAO Inhibitors, you should consult with your doctor first.
PRECAUTIONS
L-Methylfolate Glu Add is not interchangeable with folic acid. Folic acid is not effective in some patients in impacting cerebral folate levels due to low rates of folic acid transport across the bloodbrain barrier and/or low brain levels of the enzyme required to convert folic acid into a biological and functional form.
ADVERSE REACTIONS
Allergic reactions have been reported following the use of oral Quatrefolic, and Adonat.
CONTRAINDICATIONS
Hedonia® is contraindicated in patients with known hypersensitivity to any of the components contained in this product.
PATIENT INFORMATION
Hedonia® is a medical food for use under medical supervision.
PATENT INFORMATION
Hedonia® is Protected by U.S. Patent Nos. 8372451 & 9662359
RECOMMENDED USE
Usual adult dose is two Hedonia® capsules twice a day with food or as directed under medical supervision.
HOW SUPPLIED
Commercial Product (120 capsules) Available as a green capsule, size 00, with a white inner capsule. Hedonia® is not recommended for under 18 years old. Please consult your physician first.
STORAGE
Store in a cool, dry place out of the reach of children. Store in a controlled room temperature of 15˚C to 0˚C (59˚F to 86˚F) Protect from heat, light, and moisture Quatrefolic® is a registered trademark of Gnosis S.p.A., U.S. Patent No. 7,947,662. Adonat® is a registered trademark of Gnosis S.p.A.
Manufactured For: Hedonia® USA INC.
Distributed by: HedoniaUSA Inc. 7475 Wisconsin Ave, Suite 1100, Bethesda, MD 20814
Questions?
Email:customerservice@hedoniausa.com
REFERENCES
- Tobin, D.V., A.; Sarris, J., Targeting
Divergent Pathways in the Nutritional
Management of Depression. Nutrients
2024. 16. - Godfrey, P.S., et al., Enhancement of
recovery from psychiatric illness by
methylfolate. Lancet, 1990. 336(8712): p.
392-5. - Kelly, C.B., et al., The MTHFR C677T
polymorphism is associated with
depressive episodes in patients from
Northern Ireland. J Psychopharmacol,
2004. 18(4): p. 567-71. - Jiang, W., et al., Long-Chain Omega-3
Fatty Acid Supplements in Depressed
Heart Failure Patients: Results of the
OCEAN Trial. JACC Heart Fail, 2018. 6(10):
p. 833-843. - Keshavarz, S.A., et al., Omega-3
supplementation eLects on body weight
and depression among dieter women with
co-morbidity of depression and obesity
compared with the placebo: A randomized clinical trial. Clin Nutr ESPEN, 2018. 25: p. 37-43.
6. Sarris, J., et al., Adjunctive Nutraceuticals for Depression: A Systematic Review and Meta-Analyses. Focus (Am Psychiatr Publ), 2018. 16(3): p. 328-340.
7. Delle Chiaie, R., P. Pancheri, and P. Scapicchio, ELicacy and tolerability of oral and intramuscular S-adenosyl-Lmethionine 1,4-butanedisulfonate (SAMe) in the treatment of major depression: comparison with imipramine in 2 multicenter studies. Am J Clin Nutr, 2002. 76(5): p. 1172s-6s.
8. Gilbody, S., S. Lewis, and T. Lightfoot, Methylenetetrahydrofolate reductase (MTHFR) genetic polymorphisms and psychiatric disorders: a HuGE review. Am J Epidemiol, 2007. 165(1): p. 1-13.
9. Lewis, S.J., et al., The thermolabile variant of MTHFR is associated with depression in the British Women’s Heart and Health Study and a meta analysis. Mol Psychiatry, 2006. 11(4): p. 352-60.
10. Papakostas, G.I., et al., Effect of adjunctive L-methylfolate 15 mg among inadequate Responders to SSRIs in depressed patients who were stratified by biomarker levels and genotype: results from a randomized clinical trial. J Clin Psychiatry, 2014. 75(8): p. 855-63.
