What isDSIPFDA Status, Evidence and Risks (2026)
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Panel said no. Off Category 2 since Apr 2026. Voted down 6 to 7 by FDA's advisory panel in Jul 2026. Not approved by FDA for any use. Not on the 503A bulks list 1,2,3.
Part of The Sommar Peptide Guide. DSIP gets sold online as a sleep peptide. FDA's advisory panel reviewed 7 peptides in Jul 2026 and turned down one. This one. Education only.
What DSIP is
DSIP stands for delta sleep-inducing peptide. Its official name is emideltide. It is nine amino acids long: Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu 3.
FDA reviewed two forms, emideltide free base and emideltide acetate. Neither has a USP or NF monograph (an official US quality standard) 3. FDA found both forms "not registered drugs in any country searched" 3.
In rabbits, cats and rats, it raised delta brain-wave activity and lengthened sleep. It reaches the brain, and its half-life in the body is under 10 minutes 3.
Where FDA stands
- Category 2, until Apr 2026. DSIP sat on FDA's list of compounding substances that may present significant safety risks. It came off in Apr 2026, one of 12 peptides removed after their nominators withdrew them 1,4.
- Removal approved nothing. DSIP is not approved by FDA for any use and is not on the 503A bulks list, the list a pharmacy needs to compound a substance that is not part of an approved drug 2. More in Are Peptides Legal?
- FDA staff said no. On Jul 24, 2026, FDA told its advisory committee: "FDA is proposing that emideltide (free base) and emideltide acetate NOT be included on the 503A Bulks List" 3.
- The panel agreed. The Pharmacy Compounding Advisory Committee voted 6 yes, 7 no, with 1 abstention. The other 6 peptides on the agenda got a yes 5,6.
- Still advice. The vote is advisory, and FDA makes the final call 5.
- Not in the HHS policy. On Oct 28, 2026, HHS filed an interim enforcement discretion policy covering six peptides: BPC-157, TB-500, MOTS-c, epitalon, semax and KPV 7. Those are the six the panel voted for. DSIP, the one it voted down, is not one of them and keeps its prior status, as of Oct 29, 2026.
What the research shows
Evidence type: small human studies, mostly 1981 to 1998, all given by IV. FDA reviewed them for the 3 nominated uses 3.
| Use | What FDA found 3 | Limits |
|---|---|---|
| Chronic insomnia | 6 trials, 1981 to 1992, 6 to 18 people each, mostly placebo-controlled | Mixed results. Two trials found no significant difference beyond a shorter time to fall asleep in one |
| Narcolepsy | 1 case report, one man | Too limited to show anything |
| Opioid withdrawal | 2 open-label studies: 107 people (alcohol or opioids, 1984) and 7 people (1998) | No control group. In 1998, only 2 of 7 got every dose and finished detox |
FDA flagged poor control groups, small samples and baselines that did not match 3.
The nominated product was a 1 mg/mL injection under the skin. FDA found no study of DSIP given that way. On insomnia it wrote "no data to support use of emideltide via the nominated SC route," and it judged the IV data insufficient too 3.
Together, the 6 insomnia trials enrolled fewer than 80 people, all given DSIP by IV.
Known risks and FDA's concerns
FDA's stated concerns first 1,3:
- No safety data for the proposed route. FDA "has not identified safety-related information regarding emideltide for the proposed route of administration."
- Immune reactions. FDA said compounded emideltide "may pose risk for immunogenicity," possibly higher by injection under the skin, with clumping and impurities adding to it.
- Hard to characterize. Neither form is "well characterized from a physical and chemical perspective."
- Low blood pressure. In the 1984 IV study of 107 people, 2 had low blood pressure at the first injection and 1 had repeated episodes of discomfort with sweating and nausea. Some reactions were blamed on vials that did not dissolve properly.
- No toxicity or addiction studies. None found.
FDA's adverse event database returned no DSIP reports. FDA said that does not mean it is safe 3. With studies this small, there is no reliable side effect list.
Why it's sold online anyway
DSIP is sold as injections and nasal sprays, often labeled "research use only." That label is the seller saying the product is not made for people. FDA noted most of those sites do not say which form they sell 3.
What those products skip: a prescriber reviewing your health history, a licensed pharmacy, and quality testing for human use. FDA's review also notes a compounding pharmacy and its owner were sentenced for unlawfully distributing compounded drugs that included emideltide 3. More on the difference: Prescription vs Research Peptides.
Other peptides on this shelf: semax, which the same panel voted for 8 to 5, and selank, which never got a panel review.
Asked a lot.
The sources.
- FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of Apr 22, 2026). Read it
- FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (content current as of May 14, 2026). Read it
- FDA. Presentation to the Pharmacy Compounding Advisory Committee, including emideltide (Jul 24, 2026). Read it
- Frier Levitt. FDA Peptides "Do Not Compound" List Update (Apr 16, 2026). Read it
- Bass Berry. FDA Advisory Committee Recommends Six Peptides for Compounding (Jul 31, 2026). Read it
- AJMC. FDA Panel Backs 6 Peptides for Compounding (Jul 31, 2026). Read it
- HHS. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Docket HHS-OASH-2026-0496, FR Doc 2026-22192 (filed for public inspection Oct 28, 2026; scheduled to publish in the Federal Register Oct 30, 2026). Read it
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