AI illustration · not actual product photoDetails from the source.
This catalogue entry records DSIP, 5 mg × 10 vials (SKU DS5), using the supplied source listing. The cited dossier describes: Research has focused on sleep physiology and disturbed sleep. FDA-reviewed investigations also examined insomnia and, in limited reports, opioid withdrawal; narcolepsy was another proposed use evaluated by FDA. It also distinguishes available human evidence, limitations, safety concerns, and regulatory context. It does not verify this supplier-specific item’s identity, formulation, lot quality, or approval. This is not medical advice, a treatment recommendation, or authorization for human use.
- Catalogue code
- DS5
- Source specification
- 5mg*10vials
- Source document
- PriceList(1).pdf, page 1
- Photograph
- AI-generated illustration only — not an actual product photo or verified molecular depiction; owner-approved product photo still pending.
Product information is presented from supplied source materials. Inclusion on this website does not state that a product is an approved medicine or authorize human use. This is educational content, not medical advice.
Compound-level research and safety context.
Evidence below concerns the research family associated with this listing. For blends, findings about individual components do not establish evidence for the combination. This does not verify the supplier-specific vial or lot. Reviewed 2026-10-30.
What it is
DSIP is a nine-amino-acid peptide (a nonapeptide). The supplied catalogue lists DSIP as SKU DS5 (*10vials; price 41 per 10 vials) and DS10 (*10vials; price 74 per 10 vials); currency is not stated. The listing does not identify chemical form, manufacturer, or vial contents. The FDA uses DSIP for emideltide but distinguishes free base from acetate, so this alias does not establish the precise identity of either catalogue item.
Biological mechanism
The mechanism is unresolved. FDA's review describes nonclinical evidence consistent with opioid-system-dependent sleep effects involving calcium-dependent endorphin release; it reports no direct opioid-receptor interaction. These animal/in-vitro findings are not an established mechanism in humans. A peer-reviewed review describes DSIP's natural occurrence and biological activity as obscure and its sleep-factor hypothesis as weakly documented.
Research focus
Research has focused on sleep physiology and disturbed sleep. FDA-reviewed investigations also examined insomnia and, in limited reports, opioid withdrawal; narcolepsy was another proposed use evaluated by FDA. Animal and in-vitro work has explored sleep-related, opioid-system, analgesic, and withdrawal-related effects. Such proposed or studied areas are not established uses.
Potential applications in the evidence
Only studied or proposed areas can be named: disturbed sleep/chronic insomnia, and limited investigation of opioid withdrawal and narcolepsy. Evidence does not establish DSIP as an effective treatment for these conditions. Animal and in-vitro results must not be represented as human benefits.
Human evidence
Human evidence is sparse, old, and inconsistent. A double-blind study of 16 people with chronic insomnia reported weak changes in some objective sleep measures, no change in other measures, and concluded short-term DSIP was unlikely to have major therapeutic benefit. An uncontrolled seven-person report cannot establish efficacy. FDA's 2026 review found insomnia evidence preliminary and inconclusive, with small samples and design limitations; it found no evidence supporting the proposed subcutaneous route and inadequate evidence for the reviewed uses of narcolepsy or opioid withdrawal. No human study establishes benefit, long-term outcomes, or safety for the DS5/DS10 catalogue vials.
Known and potential effects
Short, historical human studies reported variable sleep-related effects. In one withdrawal-syndrome study summarized by FDA, nine participants had minor transient effects such as sweating, headache, nausea, or vertigo; three had serious events including hypotension or repeated discomfort with sweating and nausea. These reports are sparse and do not define the effects of the listed vials. FDA also noted that nonclinical activation of opioid pathways raises a theoretical addiction-potential concern; the potential has not been adequately studied. Do not imply a complete adverse-effect profile.
Safety and contraindications
FDA found insufficient safety information for the proposed subcutaneous route and identified potential immunogenicity concerns for certain routes, including peptide-related impurities and difficulties characterizing the active ingredient. FDA's concern about compounded emideltide is not evidence that these catalogue vials are compounded. The provided listing does not establish identity, salt, purity, sterility, formulation, or quality; it cannot rule out product-specific risks, interactions, allergy, contamination, or contraindications. No product-specific contraindication profile is verified.
U.S. FDA / regulatory status
FDA's May 2026 briefing states that neither emideltide free base nor emideltide acetate is a component of an FDA-approved drug and recommends against their inclusion on the 503A Bulks List. Advisory committee input is non-binding; compounding-list status is distinct from drug approval. From the available documentation, no FDA approval can be verified for the exact DSIP-labelled DS5 or DS10 vial. The catalogue does not identify manufacturer, lot, formulation source, jurisdiction, certificate of analysis, or approval status. Do not label these items compounded or research-only without reliable product-specific evidence. A later final FDA action as of 2026-10-30 could not be verified in the opened sources.
Evidence limitations
The supplied PriceList(1).pdf is the sole source for the exact listing name, SKUs, strengths, and prices; the listed currency is unspecified. FDA distinguishes emideltide free base from acetate, but this supplier label does not identify which form (if either), amino-acid sequence, or formulation is present. Evidence consists mainly of small, decades-old human studies and nonclinical findings, with differences in material, route, design, and outcomes. FDA's bulk-substance assessment cannot establish the approval, identity, quality, efficacy, or safety of a specific unidentified vial. See the research note for field-ready copy and citations.
Supporting sources
- FDA Briefing Document: Emideltide-Related Bulk Drug Substances U.S. Food and Drug Administration · Regulatory briefing document. Supports: DSIP/emideltide identity and forms; nonclinical mechanism; assessment of human studies, adverse-effect reports, route-specific safety gaps, lack of approved-drug component, and FDA's recommendation on the 503A Bulks List.
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration · Regulatory safety communication. Supports: FDA's concerns for compounded emideltide, including potential immunogenicity, peptide-related impurities, API characterization complexity, and insufficient route-specific safety information.
- Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study PubMed / National Library of Medicine · Human clinical study record. Supports: The 16-person double-blind study's limited objective findings, lack of change in other outcomes, and authors' conclusion that short-term treatment was unlikely to have major therapeutic benefit.
- Delta sleep-inducing peptide (DSIP): a still unresolved riddle PubMed / National Library of Medicine; Journal of Neurochemistry · Peer-reviewed review. Supports: Unresolved biology, uncertain natural occurrence, lack of identified gene/protein/receptor, and limitations in the proposed sleep-factor hypothesis.
- A clinical trial with DSIP PubMed / National Library of Medicine; European Neurology · Human clinical study record. Supports: The small uncontrolled seven-person insomnia report, useful as an example of limited and non-confirmatory human evidence.
- July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee U.S. Food and Drug Administration · Advisory committee meeting notice and materials index. Supports: The committee's discussion of emideltide/DSIP-related bulk substances and FDA's statement that advisory committee recommendations are non-binding.