Quick answer: there is no approved or established epitalon dosage. The only well-described human dose is a sublingual spray giving about 0.5 mg a day for 20 days, tested in 20 women working night shifts.[1][2] The 5 to 10 mg a day figures common online come from clinic websites, and from older studies of a different substance, the pineal extract epithalamin, not from trials of epitalon.[1][4]
This guide sets out every epitalon dose we could verify in published research, separates it from epithalamin doses, and explains why no safe human dose has been established. For the full background, see our epitalon profile, the Khavinson peptide bioregulators guide and the longevity peptides hub.
Epitalon vs epithalamin: why the difference matters for dosing
Epitalon (also spelled epithalon) is a synthetic peptide of four amino acids: alanine, glutamic acid, aspartic acid and glycine (AEDG). Epithalamin is a crude mixture of peptides extracted from cow pineal glands. FDA treats them as different substances, and noted that the human studies submitted with the compounding nominations were about epithalamin, not epitalon.[1]
That matters because many online dosing guides borrow epithalamin doses. A milligram of a crude extract is not the same as a milligram of a pure four-amino-acid peptide.
Epitalon dosage chart: human studies
FDA’s 2026 review found only three published studies in which people received epitalon.[1]
| Study | Who | Route and dose | Length | What was measured |
|---|---|---|---|---|
| Ivko and colleagues (St. Petersburg) | 20 women aged 40 to 50 on night shifts, vs 20 on placebo | Sublingual spray, 3 sprays twice a day; about 0.5 mg a day | 20 days | A urine melatonin marker and clock genes; not sleep |
| Khavinson and colleagues (circadian genes) | Night-shift workers | Sublingual | Not detailed by FDA | Clock gene expression |
| Khavinson and colleagues, 2002 | People with retinitis pigmentosa | Injection next to the eyeball (parabulbar) | Not stated in the abstract | Retinal function |
Sources: FDA briefing,[1] Ivko study[2] and retinitis pigmentosa study.[3]
- Sublingual study: the urine melatonin marker rose 1.7-fold, but FDA noted the paper did not describe blinding, did not measure sleep, and did not report safety data.[1][2]
- Retinitis pigmentosa: the authors reported a positive effect in 90% of patients.[3] The abstract gives no dose, and FDA could not tell whether a compounded product was used. Epitalon received a US orphan drug designation for retinitis pigmentosa in 2010, which was revoked in 2016.[1]
Epithalamin doses (not epitalon)
These are the doses most often repeated online. They come from Russian studies of the extract:
- Intramuscular injection: 5 to 10 mg a day for 10 to 20 days was a common schedule, according to an Alzheimer’s Drug Discovery Foundation review.[4]
- Intranasal: 10 to 30 mg a day for 20 to 30 days.[4]
- Repeat courses: most courses were followed by a 4- to 6-month pause before the next.[4]
- One long-term trial: older adults with heart disease received five intramuscular injections of 10 mg epithalamin, 3 days apart, every 6 months for 3 years.[4] The authors reported 28% fewer deaths over 12 years.[5]
The same review stressed that every study came from one research network, with no independent confirmation.[4]
Animal and cell doses
| Model | Dose | Schedule |
|---|---|---|
| Female mice, lifespan study | 1 microgram per mouse (about 30 to 40 micrograms per kg), under the skin | 5 days each month, from 3 months of age for life[6] |
| Cancer-prone mice | 1 microgram per mouse, under the skin | 5 days each month[7] |
| Older female mice | 0.1 microgram per injection | 5 times a week for about 6.5 months[8] |
| Older female monkeys | 2 micrograms per kg, into the muscle | Daily for 10 days[1][9] |
| Human cells in a dish | Dose-dependent effects reported | Lab exposure[10] |
These animal doses are tiny compared with the milligram amounts sold online. FDA also criticized the mouse studies for using a single fixed dose, female mice only and short total exposure, so they say little about how dose relates to effect or harm.[1]
Where the 5 to 10 mg a day figure comes from
FDA looked at how epitalon is marketed. It found wellness clinic and concierge medicine websites describing epitalon as an injection under the skin or an oral supplement, at 5 to 10 mg a day, often in cycles, with one site recommending a course every 4 months.[1] It also found products sold as 10, 20, 25 and 50 mg vials, 3 to 3.3 mg capsules and an oral spray, several labeled for research use only.[1]
The compounding nominations FDA reviewed proposed injections under the skin at 10 mg/mL and 3,000 mcg/mL. Those were product strengths, not tested doses.[1]
Epitalon dose per day: what can be said
- Studied in people: about 0.5 mg a day under the tongue for 20 days, in one small study.[1]
- Not studied in people: any dose injected under the skin, any oral capsule dose, and any dose above about 0.5 mg a day.[1]
- Not established: how long a course should last, how often to repeat it, or a maximum safe dose.
Route matters too. The human study used a spray under the tongue, while the nominations FDA reviewed were for injections under the skin. FDA found no clinical study of epitalon given by that route, for insomnia or anything else, so a sublingual dose cannot simply be reused as an injected one.[1]
A 2026 independent review concluded that epitalon’s pharmacokinetic, dose-ranging and long-term safety data remain inadequate, and called it “biologically active but clinically unproven.”[11]
If you need to convert a vial’s milligrams into syringe units for a dose a clinician has set, our peptide calculator shows the arithmetic. It cannot tell you whether a dose is appropriate.
Why no safe dose has been set
FDA found no human pharmacokinetic data, meaning nobody has measured how epitalon is absorbed or cleared in people. It found no acute or repeat-dose toxicity studies, no reproductive studies and no standard 2-year cancer studies.[1] Those are the studies normally used to pick a starting dose and a ceiling. FDA also raised a theoretical concern that continuous telomerase activation could promote cancer.[1] Our epitalon side effects guide covers these risks in detail.
Legal status
Epitalon is not approved in the US. It previously appeared on FDA’s list of compounding substances that may pose safety risks and now sits in the section for withdrawn nominations.[13] In July 2026, FDA staff recommended against allowing it in compounding for insomnia, but the advisory committee voted 7 to 5, with one abstention, in favor.[1][12] FDA had not made a final decision as of our last review.
Questions to ask a clinician
- What would I hope to gain, and how would we measure it?
- Is a sleep problem better explained by something treatable, such as sleep apnea or insomnia that responds to approved therapy?
- Do I have a personal or family history of cancer that changes the risk?
- How would we know whether a product contains what its label says?
For related reading, see epitalon vs TA-65, the best peptides for longevity and the best peptides for sleep.
This is general information, not medical advice.
