Neuropeptides
DSIP
Delta sleep-inducing peptide; emideltide
- US status
- No lawful route
- Class
- Neuropeptides
- Approved product
- None
- Route
- None lawful; sold as research-use-only material
Regulatory record
- April 2026
- Removed from Category 2 without Category 1 listing.
- July 2026
- PCAC votes 6–7 (one abstention) against recommending 503A listing — the panel's only rejection. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
- FDA final action
- None as of August 2026.
Every entry above is dated; the record is current as of the review date.
Definition
Delta sleep-inducing peptide is a nonapeptide isolated in 1977 from the cerebral venous blood of rabbits in induced sleep [1]. The name records the hypothesis of its discoverers, not an established function: nearly fifty years on, the DSIP gene, precursor protein, and receptor have never been identified.
That unresolved biology is the molecule's defining feature. A 2006 review from within the field's own literature calls the sleep-factor hypothesis “extremely poorly documented and still weak” [2].
Evidence
The human record is small, old, and equivocal. A 1981 report described improved sleep in insomniacs given the synthetic peptide [3]; a 1992 double-blind study of sixteen chronic insomniac patients found higher objective sleep efficiency and shorter sleep latency against placebo across three nights of intravenous dosing — effects its own authors judged weak, possibly an artifact of change in the placebo group, and unlikely to carry major therapeutic benefit [4].
The literature then largely stopped. No modern trial exists, and the compound is sold today for sleep and stress on the strength of a four-decade-old hypothesis its own field has not confirmed.
Lawful access
DSIP was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing, and in July 2026 the Pharmacy Compounding Advisory Committee voted against recommending it for the section 503A list — the only molecule the panel rejected at that meeting. The margin is reported as 6–7 with one abstention by McDermott Will & Schulte and by LumaLex Law, whose separate accounts agree substance by substance [5, 6]; the FDA has published no minutes, transcript or vote summary for the meeting, so that figure is secondary and this page says so wherever it appears. The committee's stated concerns tracked the record above: no established mechanism, no adequate human evidence.
No lawful US supply route exists, none is pending, and material sold online is research-use-only supply outside pharmacy oversight. The research-only page explains why removal from a list is not permission.
The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names DSIP among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [7].
Supply
No lawful US supply route exists for this molecule today. Lawfully available alternatives are recorded in the molecule index; the regulatory record on this page tracks the rulemaking that could change this.
Elsewhere in this index
Filed under
- Research-onlyNo lawful route
- Neuropeptides6 molecules in this class
- The molecule indexEvery molecule, filterable by status and class
Evidence reviews
- DSIP: The Committee's Only RejectionWhy was DSIP the only peptide the July 2026 committee refused to recommend?
Reference tables
- The July 2026 vote ledgerHow did the advisory committee vote on each peptide, and what does a vote do?
- The 2026 recordWhat happened to United States peptide compounding law in 2026, in order?
- The nomination trackerWhat became of each peptide's nomination to the 503A bulks list?
- Removal is not permissionThe peptides removed from Category 2 in April 2026 — are they lawful now?
- The human trial record, by moleculeHow many human clinical trials exist for each peptide in this index?
- The WADA Prohibited ListWhich peptides in this index are prohibited in sport, and under which class?
- Final-action watchHas the FDA finalized anything on the peptides recommended in July 2026?
Same class
- SemaxPCAC-recommended · pending
- DihexaNo lawful route
- CerebrolysinNo lawful route
- Kisspeptin-10No lawful route
- SelankNomination withdrawn
References
- Schoenenberger GA, Monnier M. Characterization of a delta-electroencephalogram (-sleep)-inducing peptide. Proc Natl Acad Sci U S A. 1977;74(3):1282–1286. PMID 265572
- Kovalzon VM, Strekalova TV. Delta sleep-inducing peptide (DSIP): a still unresolved riddle. J Neurochem. 2006;97(2):303–309. PMID 16539679
- Schneider-Helmert D, Graf M, Schoenenberger GA. Synthetic delta-sleep-inducing peptide improves sleep in insomniacs. Lancet. 1981;1(8232):1256–1257. PMID 6112579
- Bes F, Hofman W, Schuur J, Van Boxtel C. Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study. Neuropsychobiology. 1992;26(4):193–197. PMID 1299794
- McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. This report gives the tally for each substance and states that FDA scientists recommended against inclusion in each instance. Source
- LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance. Source
- US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. Source