DSIP

Delta sleep-inducing peptide

Grade B: Human evidence, not approved for this use

TL;DR: DSIP (delta sleep-inducing peptide) is a nonapeptide isolated from rabbit brain in the 1970s; its physiological role in humans remains incompletely characterized. The primary human RCT cited in support of a sleep benefit (PMID 3622582, European Neurology, 1987) enrolled only 14 middle-aged participants with chronic insomnia under placebo-controlled, double-blind conditions over seven nights and reported subjective sleep improvements; this trial has not been replicated in a modern adequately powered controlled study. Additional human evidence is limited to small, older studies of heterogeneous quality, many conducted in the 1980s. The mechanistic basis for DSIP's reported sleep effects is not established, and the peptide's endogenous physiological function in humans is still debated in the literature. By the standard evidence-grading rubric, at least one human RCT places DSIP in Grade B; however, the evidence quality within Grade B is very low given the single trial's small sample, its age, and the complete absence of modern replication. DSIP should not be equated with compounds at the upper range of Grade B evidence.

Key Takeaways

Grade B: Human evidence, not approved for this use
Not FDA approved: Not FDA-approved; previously in 503A Category 2 (significant safety concerns); scheduled for PCAC review July 24, 2026 with no compounding authorization confirmed as of June 2026.
Compounding: The nomination to add DSIP to the FDA 503A or 503B bulk-substances list was withdrawn; it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding.

DSIP chemical structure — Structure via PubChem CID 68816

Mechanism

DSIP is proposed to promote slow-wave sleep and modulate circadian rhythms through actions on central neuroendocrine pathways, but the specific receptor target and mechanism are not conclusively established in humans.

Evidence

DSIP (delta sleep-inducing peptide) is a nonapeptide isolated from rabbit brain in the 1970s; its physiological role in humans remains incompletely characterized. The primary human RCT cited in support of a sleep benefit (PMID 3622582, European Neurology, 1987) enrolled only 14 middle-aged participants with chronic insomnia under placebo-controlled, double-blind conditions over seven nights and reported subjective sleep improvements; this trial has not been replicated in a modern adequately powered controlled study. Additional human evidence is limited to small, older studies of heterogeneous quality, many conducted in the 1980s. The mechanistic basis for DSIP's reported sleep effects is not established, and the peptide's endogenous physiological function in humans is still debated in the literature. By the standard evidence-grading rubric, at least one human RCT places DSIP in Grade B; however, the evidence quality within Grade B is very low given the single trial's small sample, its age, and the complete absence of modern replication. DSIP should not be equated with compounds at the upper range of Grade B evidence.

Safety and risks

No systematic human safety data exist for exogenous DSIP administration beyond very small and old studies. The FDA explicitly noted that 'no safety-related information regarding DSIP has been identified, so it is unknown whether it could be harmful to humans,' and cited immunogenicity as a specific concern: compounded DSIP may trigger an immune response, potentially life-threatening, because the body may perceive exogenous peptide as foreign. The peptide's influence on LH and GH release reported in preclinical studies raises the possibility of uncharacterized hormonal disruption at supraphysiologic doses, though human data are absent. Risks of long-term exogenous DSIP administration, drug interactions, effects in pregnant or immunocompromised individuals, and dose-response toxicity are entirely unknown. Compounded DSIP preparations carry the quality and contamination risks common to all unregulated peptide injectables, including microbial contamination and synthesis impurities. As of April 2026, DSIP (emideltide) was removed from FDA Category 2 of the 503A interim list pending PCAC review scheduled for July 24, 2026; this review has not yet concluded.

Interactions

No human interaction data exist. Theoretical additive CNS depression with sedative-hypnotic drugs, benzodiazepines, or opioids is plausible given the peptide's proposed sleep-promoting activity, but this has not been studied.

Federal compounding status

Nomination withdrawn (was Category 2) as of 2026-06-02.

This substance was nominated for the FDA 503A or 503B bulk-substances list and previously sat in the Category 2 (significant safety risk) group; the nomination was later withdrawn, so it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding. FDA source

Federal status only, from public FDA records. State pharmacy-board rules vary and are not covered here. This is regulatory reporting, not legal advice. All compounds.

Compounding legality

The nomination to add DSIP to the FDA 503A or 503B bulk-substances list was withdrawn; it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding.

Sources

DSIP is Not FDA approved. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 1, 2026 by PeptideGrids editorial team (independently audited).