Human insomnia evidence is tiny, old and internally conflicting: a 1987 double-blind study reported substantial improvement, while a 1992 double-blind study found weak/inconsistent effects and considered major therapeutic benefit unlikely.
Regulatory status
Not FDA-approved; FDA lists DSIP/emideltide among substances with insufficient safety information.
Main limitations
Reliable insomnia efficacy, chronic safety, modern subcutaneous use or a validated treatment regimen.
Safety
Human safety data are sparse and dated; FDA says it lacks sufficient safety information for proposed compounded routes.
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Human insomnia evidence is tiny, old and internally conflicting: a 1987 double-blind study reported substantial improvement, while a 1992 double-blind study found weak/inconsistent effects and considered major therapeutic benefit unlikely.
What the evidence actually supports
✓DSIP should not be presented as an evidence-based sleep treatment.
✓The correct page conclusion is 'conflicting small human evidence', not 'proven sleep peptide'.
✓Pair the old insomnia literature with the current safety-information gap.
What is not established / key limitations
×No robust replicated modern clinical benefit.
×The later controlled study did not support a major therapeutic effect.
×No adequate route-specific modern safety framework.
Selected study & evidence records
Double-blind DSIP study in chronic insomnia
1992 · Double-blind controlled clinical study · n=16
Some objective signals occurred, but effects were weak/inconsistent and investigators considered major therapeutic benefit unlikely.
Route / formulation boundaryOlder IV research does not validate modern nasal/injectable commercial products.
Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.
Dosing evidence statusVerified dosing evidence added. Published human insomnia-study regimen. See dosing_evidence records for route, regimen, population, duration and source.
Identifiers & alternate namesDSIP · Emideltide
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.