DSIP

Delta sleep-inducing peptide (DSIP / emideltide) had small human sleep studies decades ago; it is not FDA-approved, and FDA lists it among nominated-but-withdrawn compounding substances with insufficient safety information.

A nonapeptide originally isolated in sleep research and studied as a putative sleep-promoting peptide (emideltide is the INN-style name used in FDA compounding documents) [R1][FDA-RISK].

Not FDA-approved. FDA lists Emideltide (DSIP) under "bulk drug substances nominated but withdrawn" from Category 2 interim-policy tables, stating compounded DSIP may pose immunogenicity and impurity-characterization concerns and that FDA has not identified sufficient safety information for the proposed route - so it lacks information to know whether the drug would cause harm in humans [FDA-RISK].

• Small 1980s clinical reports from Schneider-Helmert and colleagues described sleep EEG / insomnia effects of synthetic DSIP in limited samples [R1][R2][R3].
• These studies are old, small, and not equivalent to modern Phase 3 programs. Efficacy for contemporary insomnia care is not established by FDA-reviewed evidence.

Historical animal sleep and neuroendocrine work exists; it does not establish clinical benefit or safety for modern compounded products.

FDA: insufficient human safety characterization for proposed compounding routes [FDA-RISK]. Gray-market vials: identity, purity, sterility unverified. No modern large RCTs identified in this check.

No pending FDA approval identified. Watch interim peptide compounding policy developments [OIRA].