Delta sleep-inducing peptide

Investigated uses

• Insomnia, narcolepsy and opioid withdrawal in old small studies.

Mechanism and hypotheses

• No validated clinically relevant receptor mechanism has been established for DSIP/emideltide.
• Hypothesized: Sleep, stress and neuroendocrine effects have been proposed, but old human studies were small, heterogeneous and inconclusive.

Human evidence

• Older small human studies used heterogeneous intravenous protocols for insomnia, narcolepsy or opioid withdrawal; FDA characterized the evidence as preliminary or inconclusive. Limitations: Very small samples, old methods, non-subcutaneous routes and incomplete safety characterization.

Safety highlights

• Old human reports are too small and heterogeneous to estimate incidence.
• Immunogenicity, impurities and CNS/endocrine effects remain inadequately characterized.

Regulatory context

No FDA-approved DSIP/emideltide drug was identified. In July 2026, PCAC did not recommend Emideltide-related bulk drug substances for inclusion on the 503A Bulks List for opioid withdrawal, chronic insomnia, and narcolepsy. The vote was advisory and not an FDA drug-approval decision.