Now reading Entry 022 / 102 Last revised Sep 28, 2026 15 sources 2 comparisons Methodology →
A specimen of the Cognitive drawer Drawer E · Cognitive

DSIP

Research Only

DSIP (emideltide) is a nine-amino-acid peptide investigated for sleep. Small, older intravenous studies in people with insomnia produced conflicting results; benefit for insomnia has not been established. Animal findings do not establish effects in people.

Delta sleep-inducing peptide · Emideltide · WAGGDASGE

Research evidence
Very Low

Human insomnia results are small, old, conflicting, and limited to intravenous administration. Neither clinical benefit nor safety for other routes or combinations is established.

Preclinical
40%
Human research
47%

Based on 15 cited sources

Selected cited publications: seven individual human investigations, six preclinical reports, one overlapping human-program report, and one review. These are publications, not independent trials or unique participants; the 1983 program report describes five human studies and may overlap the individually cited papers. The sole confirmed open full text among these publications is PMID 265572 (PMCID PMC430668). The FDA briefing is a separate regulatory assessment, not another trial.

Evidence score pending review

Historical numeric evidence and effectiveness scores are withheld pending a documented, publication-deduplicated rubric reassessment. Small, conflicting intravenous insomnia studies and overlapping reports do not support a precise clinical-effectiveness number.

This is a limitation of the numeric assessment, not a measured absence of benefit. It does not re-review the separately recorded catalogue classification or establish efficacy or safety.

  • Study identity requires review
  • Assessment incomplete
  • Scoring method unresolved

Status date:

Scoring context and limitations
!!
Evidence Level
very low
FDA's July 2026 Pharmacy Compounding Advisory Committee materials evaluated emideltide free base and acetate for the 503A bulk-drug-substances list.
Research Only
Identity
SCALE · 1:1 N-TERMINUS C-TERMINUS 9 AA · 848.8 Da (free base)
Also Known As
Delta sleep-inducing peptide • Emideltide • WAGGDASGE
Class
Nonapeptide
Length
9 amino acids
Mol. weight
848.8 Da (free base)
Sequence
WAGGDASGE
Molecular Structure
W
A
G
G
D
A
S
G
E
Hydrophobic
Polar
Positive
Negative

DSIP’s name reflects an early hypothesis about sleep. It does not mean the peptide reliably induces delta sleep or treats insomnia. The original chemical characterization identified the nine-residue sequence in rabbit experiments (PMID 265572). A later review questioned whether DSIP itself is an endogenous sleep factor and described the evidence for that role as weak (PMID 16539679).

What have human sleep studies found?

An early experiment in six healthy volunteers reported changes in daytime and subsequent night sleep after intravenous DSIP (PMID 6895513). Another six-person study in chronic insomnia reported longer and less interrupted sleep (PMID 7028502). Later reports from the same research group described improvements in groups of 18 and 14 people with chronic insomnia (PMID 3792404; PMID 3622582). A 1983 paper summarizes five human studies; it must not be counted as five additional independent trials or participants (PMID 6689058).

The results did not replicate consistently. A double-blind crossover study by Monti and colleagues found that apparent sleep changes were of little clinical significance (PMID 3583493). A separate double-blind, placebo-controlled study of 16 people with chronic insomnia found weak objective signals, no improvement in subjective sleep quality, and concluded that short-term DSIP was unlikely to provide major therapeutic benefit (PMID 1299794). FDA’s 2026 review judged the overall intravenous insomnia evidence inconclusive and found no effectiveness study for the proposed subcutaneous route (FDA emideltide briefing, pp. 24–31). These findings do not justify a claim that DSIP normalizes sleep in people.

What do the other findings mean?

In rats, one experiment linked DSIP-related sleep signs to a response blocked by the serotonin antagonist methysergide; that is a mechanistic clue, not a validated human treatment pathway (PMID 6132892). A rabbit study found altered EEG activity (PMID 265572), while another study found no statistically significant sleep effect of the parent DSIP in rabbits even though some analogues did affect sleep (PMID 11525128).

Other animal experiments reported mitochondrial changes during hypoxia and altered oxidative markers during cold stress (PMID 12668217; PMID 11421812). Centrally administered DSIP changed pain-response tests in mice and rats; naloxone blocked that effect (PMID 2853064). None of those experiments establishes a sleep, pain, or stress-protection benefit in humans. In a separate 11-person human crossover study, ACTH-like immunoreactivity fell after intravenous DSIP, while plasma and urinary cortisol did not change; this was a hormone-marker study, not evidence of an insomnia or stress treatment (PMID 2554357).

Regulatory and safety context

FDA’s July 2026 briefing proposed against adding emideltide free base and acetate to the 503A bulks list, citing limited effectiveness and safety information and product-characterization concerns. It found no safety data for the proposed subcutaneous route. That proposal should not be described as a final rule or an approval (FDA briefing, pp. 52–55; FDA meeting page). The available studies also do not establish whether DSIP can be combined safely with Selank, Semax, Epithalon, melatonin, or other products.

This page summarizes research for education. It does not provide treatment, dosing, product-quality, or purchasing guidance.

  1. 001

    Human insomnia studies are small, old, and conflicting; some publications may report overlapping participants.

  2. 002

    The cited human sleep experiments used intravenous DSIP, so their findings do not transfer to another route.

  3. 003

    No validated clinical effect size, long-term benefit, or combination-safety evidence is established here.

  4. 004

    Animal sleep, pain, and oxidative-marker findings cannot establish patient outcomes.

15 Sources 7 Human 6 Preclinical

Use the source links in the research discussion above to inspect the referenced records.

This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength labels summarize the cited material for this entry and should be read alongside its population, model, and study limitations.

For complete methodology details, see our Methodology page.

Important Disclaimer

This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.

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Safety profile DSIP: adverse events, contraindications and monitoring →

Compared With

2 comparisons

Conditions Studied

3 entries

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