Hedonia Medical Food
Hedonia is a medical food for the dietary management of the nutritional requirements associated with depression, intended for use under medical supervision alongside a physician-directed treatment plan. It provides three nutrients in one capsule: EPA omega-3, L-methylfolate and SAMe. The directions are two capsules twice a day, i.e. four capsules daily.
Daily dose
4
capsules daily
Directions
2 + 2
twice daily with food
Category
Medical food
not a drug or supplement
DAILY FORMULATION
Three nutrients in one capsule
EPA omega-3
1,440 mg
from 1,800 mg total omega-3
L-methylfolate
15 mg
from 20 mg Quatrefolic®
SAMe
1,200 mg
as Adonat® Premium
What is in Hedonia?
Daily figures are for research comparisons. Per-capsule figures are for reading the label.
Nutrient
Per day (four capsules)
Per capsule (one capsule)
EPA omega-3
1,440 mg EPA, from 1,800 mg omega-3 triglycerides
360 mg EPA
L-methylfolate
15 mg L-methylfolate, from 20 mg Quatrefolic® L-methylfolate glucosamine
5 mg Quatrefolic®, providing 3.75 mg L-methylfolate
SAMe
1,200 mg SAMe, as Adonat® Premium SAMe
300 mg SAMe
Both columns describe the same product. The per-day figures are the ones to use when comparing Hedonia with the doses used in published trials, since trials report daily intake.
Other ingredients: purified omega-3 fish oil as OmegaTex®, S-adenosylmethionine as Adonat®, L-methylfolate glucosamine as Quatrefolic®, gellan gum, hypromellose, silicon dioxide, sodium copper chlorophyllin.
Quatrefolic® and Adonat® are registered trademarks of Gnosis S.p.A. Quatrefolic® is covered by US Patent No. 7,947,662.
How is it taken?
Two capsules twice a day, with food, or as directed by a physician. Hedonia is formulated for adults. It is intended for use under medical supervision, alongside rather than instead of a physician-directed treatment plan.
What regulatory category is it in?
Hedonia is a medical food, a category defined in the Orphan Drug Act at 21 USC 360ee(b)(3), with labelling requirements at 21 CFR 101.9(j)(8). Medical foods do not undergo FDA pre-market approval, which is a requirement that applies to drugs. They must comply with FDA requirements for the category, including current Good Manufacturing Practice and the applicable labelling rules.
Who should speak to a doctor first?
Anyone who is pregnant or nursing, anyone diagnosed with bipolar disorder, and anyone taking MAO inhibitors should consult a doctor before taking Hedonia. As a medical food, Hedonia is intended for use under medical supervision in any case.
The fuller safety wording lives on the science page and is with Hedonia’s regulatory reviewer.
The fuller safety wording lives on the science page and is with Hedonia’s regulatory reviewer.
Who makes it?
Manufactured for and distributed by HedoniaUSA Inc., 7475 Wisconsin Avenue, Suite 1100, Bethesda, MD 20814. Hedonia is protected by US Patent Nos. 8,372,451 and 9,662,359.
The evidence behind the formulation
Converging evidence
The three nutrients in Hedonia are the three that the adjunctive evidence converges on. A systematic review and meta-analyses in the American Journal of Psychiatry concluded that current evidence supports the adjunctive use of SAMe, methylfolate and omega-3 with antidepressants to reduce depressive symptoms.
Combination rationale
The rationale for combining the three, rather than using any of them alone, is set out in Tobin, Vuckovic and Sarris in Nutrients in 2024, which is a narrative review, i.e. a published statement of the rationale rather than a trial of the combination.
References
- Sarris J, Murphy J, Mischoulon D, Papakostas GI, Fava M, Berk M, Ng CH. Adjunctive nutraceuticals for depression: a systematic review and meta-analyses. Am J Psychiatry. 2016;173(6):575-587. PMID: 27113121. PubMed
- Sarris J, Ravindran A, Yatham LN, Marx W, Rucklidge JJ, McIntyre RS, et al. Clinician guidelines for the treatment of psychiatric disorders with nutraceuticals and phytoceuticals: the WFSBP and CANMAT Taskforce. World J Biol Psychiatry. 2022;23(6):424-455. PMID: 35311615. PubMed
- Tobin D, Vuckovic A, Sarris J. Targeting divergent pathways in the nutritional management of depression. Nutrients. 2024;16(16):2806. PMID: 39203943. Full text
- US Food and Drug Administration. Guidance for industry: frequently asked questions about medical foods, third edition. March 2023. Docket FDA-2013-D-0880. FDA guidance