Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-15. ← Back to Evidence Library
DSIP (delta sleep-inducing peptide): what the evidence says
At a glance
What it is: a 9-amino-acid peptide first isolated in 1977 from the blood of sleeping rabbits and named for the deep "delta" sleep it seemed to cause. FDA calls it emideltide. In Russia it is registered as an over-the-counter nasal medicine (Deltaran). On the gray market it is sold, mostly as an injection, for sleep, stress and recovery. R1, R9, R10
What the evidence says: small 1980s–90s trials tested it for chronic insomnia. Two placebo-controlled trials found no meaningful benefit; one 14-person trial reported strong benefit. Withdrawal and other uses rest on open trials and Russian studies we could read only as abstracts. R2, R3, R4, R5
Biggest risks: we found very little human safety data. In one study it sped up heart rate and lightened anesthesia. The Russian label lists allergic reactions and nasal irritation. Gray-market vials have no quality guarantees. R6, R9
| Claim | Rating |
|---|---|
| Human Chronic insomnia (sleep) | Very limited (mixed results): three tiny IV trials from 1987–1992 (human, into a vein). Two double-blind trials (16 people; one crossover whose size the abstract doesn't give UNVERIFIED) found no meaningful benefit over placebo; one 14-person trial reported benefit R2, R3, R4 |
| Human Opioid or alcohol withdrawal, stress (the Russian-approved uses) | Very limited: one open-label opioid detox trial (no control group) and Russian studies we've only seen as abstracts or titles R5, R11 |
| Unknown Injected under the skin for sleep, recovery, longevity, other uses | No human data for this route and these uses (nothing at all that we found; two of the three insomnia trials used IV injection; the third doesn't state the route) |
| Animal Animal evidence | Rat and mouse studies on sleep, seizures, stroke and alcohol withdrawal; not reviewed in detail for this page R12 |
| Regulatory | Russia: registered OTC (Deltaran) · US: not FDA-approved; on FDA's significant-safety-risks page (nomination withdrawn); FDA proposed it NOT be added to the 503A compounding list (July 2026) · WADA 2026: not named R7, R8, R9, R13 |
| Established human dose | Unknown None outside the Russian label; no Western regulator has reviewed a dose |
Evidence verdict: Chronic insomnia: Very limited (mixed results) · Withdrawal and stress: Very limited · Injected use for sleep, recovery, longevity and other uses: No human data Card verdict: Very limited (chronic insomnia, mixed results; alcohol/opioid withdrawal) · Injected sleep, recovery, longevity: No human data Card note: Varies by use, see page
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
What "No human data" means here: for subcutaneous (under-the-skin) use, and for recovery, longevity and other gray-market uses, we found nothing at all in people. Two of the human sleep trials gave it into a vein; the third gave injections by an unstated route.
What is it?
DSIP is a nonapeptide, a chain of 9 amino acids (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu). It was isolated in Switzerland in 1977. Despite the name, scientists have never found a DSIP gene or receptor (the "lock" on cells that a molecule fits). How it might work is unclear. Caution [UNVERIFIED: "no gene or receptor identified" from review literature, not re-checked in a primary source] R1, R12
Much of the later research was done in the Soviet Union and Russia, which led to the Deltaran registration. R9, R11
Does it work?
Human Chronic insomnia (all IV, short-term, 1987–1992): - Bes 1992 (Netherlands), 16 patients, double-blind, 3 nights: sleep efficiency and time to fall asleep looked slightly better, but the authors said the effects "were weak and in part could be due to an incidental change in the placebo group," and subjective sleep quality didn't change. They concluded DSIP "is not likely to be of major therapeutic benefit." R2 - Monti 1987 (Uruguay), double-blind crossover (each person got both DSIP and placebo, at different times), 4 nights: awakenings and waking time didn't differ significantly from placebo. Where differences appeared, they were already there at baseline. Conclusion: "of little clinical significance." R3 - Schneider-Helmert 1987 (Switzerland), 14 patients, placebo-controlled, double-blind, 7 nights (given as injections; the abstract doesn't say which route): reported clearly better sleep and daytime alertness. This was a small trial from the group most associated with DSIP research. Caution [UNVERIFIED: design details beyond the abstract] R4
The results point in different directions, and all three trials were tiny and short. That's why we rate insomnia Very limited (mixed results). We did not use "Tested, not shown": the trials were too small and inconsistent to count as a clear negative finding.
Human Opioid withdrawal: one open-label trial in Germany (everyone knew what they got, and there was no control group) reported on DSIP for detox. We have only the citation. There is no abstract. Caution [UNVERIFIED: results not read] R5
Human Russian-language research: CyberLeninka lists Russian clinical papers on Deltaran in psoriasis (2008), post-stroke cognitive problems (2012, with Semax), children's neurological disease (Deltalicin, 2012), and diabetic retinopathy (2014). We have read only titles and abstracts, not full texts or translations. None was placebo-controlled as far as the abstracts show. Caution [UNVERIFIED: designs, sizes and funding; eLibrary.ru not searched] R11
Human During anesthesia: in 24 women having surgery, DSIP raised heart rate and made anesthesia lighter, the opposite of a sleep effect. R6
Is it safe?
- Caution Heart rate and anesthesia: DSIP increased heart rate, reduced heart rate variability (the natural beat-to-beat variation) and lightened anesthesia depth in one randomized study. R6
- Caution Russian label (Deltaran, nasal): possible allergic reactions and nasal irritation; not for use in pregnancy, breastfeeding, or under age 18. R9
- Unknown The insomnia trial abstracts don't report side effects or dropouts, so we can't compare dropouts with placebo. Caution [UNVERIFIED: full texts not checked]
- Caution FDA: "Compounded drugs containing emideltide may pose risk for immunogenicity [an immune reaction] for certain routes of administration and may have complexities with regard to peptide-related impurities." FDA says it "lacks sufficient information to know whether the drug would cause harm if administered to humans." R7
What we don't know
- Unknown Whether it improves sleep in any lasting, meaningful way
- Unknown Any human data for under-the-skin injection
- Unknown Long-term safety
- Unknown What the Russian trials found in full, and who funded them
Is it legal?
- Russia: Deltaran (DSIP, nasal), registration LP-003849, reissued as LP-№(016126)-(RG-RU) dated July 31, 2026 (unlimited term), holder NIC KOMKON; over the counter. Indications: as part of combined treatment for stress-related conditions, alcohol withdrawal and alcohol craving. Registration numbers, date, holder and OTC status confirmed on Vidal (Oct 15, 2026). Caution [UNVERIFIED in the government register GRLS, which we couldn't read automatically] R9
- FDA / EU / elsewhere: not FDA-approved, and we found no approval in the EU, China or Japan (not in the EMA's list of centrally authorised medicines, checked Oct 15, 2026; Caution [UNVERIFIED: China/Japan registries not searched directly]). FDA lists emideltide on its "significant safety risks" page under bulk substances "nominated but withdrawn" (content current Apr 22, 2026). It's not on the 503A bulks list and has no entry in the 503A nominations list (May 14, 2026). For the July 24, 2026 Pharmacy Compounding Advisory Committee meeting, FDA reviewed it for opioid withdrawal, chronic insomnia and narcolepsy and proposed that emideltide "NOT be included" on the 503A list. Reuters reported (July 24, 2026) that the committee voted 7 against and 6 for adding it, with 1 abstention. (vote count confirmed in the Reuters article; FDA's official minutes not yet found) FDA has not issued a final decision. R7, R8, R13
- Athletes: DSIP is not named on WADA's 2026 list. S0 bans substances "with no current approval by any governmental regulatory health authority for human therapeutic use." Because DSIP is a registered medicine in Russia, S0 likely doesn't apply. It could still fall under another section. Unknown This is our reading, not a WADA ruling. R14
What's in the vial?
Gray-market "DSIP" is not Deltaran (a nasal product made under Russian regulation), and no Western-approved version exists. Some people also make their own nasal spray by mixing gray-market DSIP powder with saline or with saline and bacteriostatic water. A home-mixed spray is not the same as regulated Deltaran: its strength, sterility and stability are unknown. Caution [UNVERIFIED: no source yet cited for home-mixed nasal use] A gray-market vial has no quality control and no guarantee of identity. It could hold the wrong compound or amount, impurities, bacterial toxins, or be fake (counterfeit). We test retail vials blind under the Open Peptide Standard. See results at /tests/. A passing test covers one batch, tested on one date. It does not mean the compound itself is safe.
What do users report?
Self-report, not evidence.
Unknown TBD. We'll only list this once we can cite a public source.
Study details
R2–R6 Human Human studies
Funding for the 1980s–90s trials is not stated in the abstracts. Caution [UNVERIFIED: funders and conflicts not checked against full texts]
| Study | People | Route | Dose used (study arm, not a recommendation) | Follow-up | Reported | Limitations | Citation |
|---|---|---|---|---|---|---|---|
| Bes 1992, chronic insomnia | 16, double-blind matched-pair parallel groups | IV, afternoon | 25 nmol/kg, 3 days | 5 lab nights | Weak objective effects, possibly due to placebo-group change; no change in subjective sleep | Tiny; 3 nights | PMID 1299794 |
| Monti 1987, chronic insomnia | Caution [UNVERIFIED: n], double-blind crossover | IV | 25 nmol/kg, 4 nights | Short | No significant differences vs placebo for awakenings/waking time; "little clinical significance" | Tiny; baseline imbalance | PMID 3583493 |
| Schneider-Helmert 1987, severe chronic insomnia | 14, placebo-controlled, double-blind | Injection, route not stated UNVERIFIED | UNVERIFIED | 7 nights + 1 placebo night | Better night sleep and daytime alertness | Tiny; single investigator group | PMID 3622582 |
| Backmund 1998, opioid detox | UNVERIFIED | UNVERIFIED | UNVERIFIED | UNVERIFIED | Caution [UNVERIFIED: no abstract] | Open-label, no control | PMID 9617990 |
| Pomfrett 2009, anesthesia (human) | 24 women (12 DSIP, 12 saline), randomized | IV | 25, 50 or 100 nmol/kg | During surgery | Heart rate up, HRV down, anesthesia lighter | Not a sleep study | PMID 19142086 |
| Kresiun 2014 (Russian; abstract in English only), diabetic retinopathy | 30 patients + 15 healthy controls | Nasal (Deltalicin) | 0.3 mg daily, 2 months | 2 mo | Faster visual recovery after light stress (an eye-test measure, not a vision benefit) | No placebo group described; abstract only | PMID 25739189 |
R7–R14 Regulatory and other sources (as of Oct 15, 2026)
- R1 Graf MV, Kastin AJ. Delta-sleep-inducing peptide (DSIP): an update. Peptides. 1986;7(6):1165-87. PMID 3550726 (background).
- R7 FDA, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current 04/22/2026): emideltide (DSIP) under "Bulk drug substances nominated but withdrawn," with the statement quoted above. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R8 FDA 503A lists: 21 CFR 216.23; 503A nominations list (updated May 14, 2026; no emideltide entry): https://www.fda.gov/media/94155/download
- R13 FDA, PCAC meeting materials, July 23–24, 2026: "FDA is electing to proceed with the presentation of Emideltide-related bulk drug substances"; "FDA is proposing that Emideltide (free base) NOT be included" and same for emideltide acetate. https://www.fda.gov/media/193342/download ; Federal Register meeting notice, Apr 16, 2026 (uses evaluated: opioid withdrawal, chronic insomnia, narcolepsy): https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request
- R9 Russia, Deltaran label via Vidal drug reference (updated June 4, 2026): https://www.vidal.ru/drugs/deltaran ; RLS: https://www.rlsnet.ru/drugs/deltaran-78384 . Read in Russian; translation ours.
- R10 Name "emideltide" as used by FDA R7, R13.
- R11 CyberLeninka search (Russian), Oct 15, 2026: e.g. https://cyberleninka.ru/article/n/klinicheskaya-effektivnost-kompleksnoy-terapii-psoriaza-s-primeneniem-deltarana ; https://cyberleninka.ru/article/n/primenenie-peptida-delta-sna-i-semaksa-v-sochetanii-s-elektroneyromiostimulyatsiey-v-lechenii-postinsultnyh-kognitivnyh-rasstroystv ; https://cyberleninka.ru/article/n/effektivnost-delta-son-indutsiruyuschego-peptida-pri-narushenii-metabolizma-neyromediatorov . Titles/abstracts only.
- R12 Animal work, e.g. Shandra 1998, PMID 9762721 (rat stroke model); Stanojlović 2005, PMID 15911358 (rat seizures). Not reviewed in detail.
- [R13b] Reuters, July 24, 2026: "FDA panel votes to exclude peptide emideltide from pharmacy compounding list" (7 against, 6 for, 1 abstained). https://www.reuters.com/business/healthcare-pharmaceuticals/fda-panel-votes-exclude-peptide-emideltide-pharmacy-compounding-list-2026-07-24/ ; FDA voting questions: https://www.fda.gov/media/193711/download
- R14 WADA 2026 Prohibited List (official PDF text, saved copy; DSIP/emideltide not named; S0 wording quoted above). https://www.wada-ama.org/en/resources/world-anti-doping-code-and-international-standards/prohibited-list
Full reference list (PMIDs verified on PubMed, Oct 15, 2026)
- R2 Bes F, et al. Neuropsychobiology. 1992;26(4):193-7. doi:10.1159/000118919. PMID 1299794
- R3 Monti JM, et al. Int J Clin Pharmacol Res. 1987;7(2):105-10. PMID 3583493
- R4 Schneider-Helmert D. Eur Neurol. 1987;27(2):120-9. doi:10.1159/000116143. PMID 3622582
- R5 Backmund M, et al. J Clin Psychopharmacol. 1998;18(3):257-8. doi:10.1097/00004714-199806000-00016. PMID 9617990
- R6 Pomfrett CJ, et al. Eur J Anaesthesiol. 2009;26(2):128-34. doi:10.1097/EJA.0b013e32831c8644. PMID 19142086
- Kresiun NV, Godlevskiĭ LS. Eksp Klin Farmakol. 2014;77(12):22-5. PMID 25739189 (Russian; English abstract only)
Disclaimer
This page is for education and harm reduction. It is not medical advice and not a recommendation to use DSIP. Please talk to a clinician you trust, especially if you have a heart condition, are having surgery, are pregnant or breastfeeding, or are a tested athlete. Seek care right away for a serious reaction, and report it to FDA MedWatch (https://www.fda.gov/safety/medwatch).