DSIP (delta sleep-inducing peptide)

Summary

DSIP (delta sleep-inducing peptide) is a nine amino acid peptide isolated in 1977 from blood draining the brains of rabbits in induced sleep and later found in humans. Three small double blind trials (neither patients nor researchers knew who got the peptide) in chronic insomnia in the late 1980s and early 1990s gave inconsistent results, with modest changes in sleep on some measures and none on others, and a 2006 review concluded its role in the body is still unresolved. It is not FDA approved; FDA removed it from the 503A Category 2 list (compounding ingredients flagged for significant safety risks) on April 15, 2026, but the Pharmacy Compounding Advisory Committee (FDA's outside expert panel) voted against adding it to the 503A bulks list (ingredients pharmacies may use to compound drugs for individual patients) on July 23 to 24, 2026.

What is DSIP (delta sleep-inducing peptide)?

DSIP (delta sleep-inducing peptide) is an endogenous nonapeptide (9 amino acids) first isolated from the cerebral venous blood of rabbits during induced sleep. It is also known as Delta sleep-inducing peptide, Emideltide, DSIP peptide, Deltaran.

How does it work?

Uncertain. DSIP does not bind a known dedicated receptor. Proposed actions include modulation of GABAergic and glutamatergic transmission, effects on the hypothalamic pituitary axis (it lowers stress induced ACTH and cortisol release in some animal studies), and influence on the circadian regulation of slow wave sleep. Its very short plasma half life and poor blood brain barrier penetration raise doubts about how injected DSIP acts on the brain at all.

What does the evidence say about DSIP (delta sleep-inducing peptide)?

Evidence is limited to small double blind placebo controlled trials from 1987 to 1992 in chronic insomnia, none larger than a few dozen patients. Schneider-Helmert 1987 reported improved 24 hour sleep wake behavior in severe chronic insomnia; Monti 1987 found only short lived effects; Bes 1992 found effects that did not persist and were inconsistent across measures. No modern trial exists, and a 2006 review called DSIP an unresolved riddle. Human evidence is therefore graded as randomized but weak, old, and unreplicated.

Human evidence

Schneider-Helmert 1987: severe chronic insomnia patients given intravenous DSIP in a double blind crossover design showed improvements in sleep efficiency and daytime alertness. Monti 1987: chronic insomniacs given DSIP for several nights showed some improvement in sleep latency early in treatment that was not sustained. Bes 1992: double blind study in chronic insomnia found small effects on some polysomnographic measures with no consistent overall benefit. No dose response, long term, or oral study exists, and no trial has tested the subcutaneous form sold today.

Animal evidence

In rabbits and rats, DSIP infused into the brain or bloodstream increased delta (slow wave) EEG activity in some experiments and not in others; the original sleep inducing effect was difficult to replicate across laboratories. Rodent studies also report reduced stress hormone release, antioxidant effects, and anticonvulsant activity. The animal literature is decades old and contradictory.

Key studies

Conditions studied

Is DSIP (delta sleep-inducing peptide) legal in the United States?

FDA and compounding status

Not an FDA approved drug. DSIP was placed on the FDA 503A Category 2 list in 2023 and was one of the peptides FDA now lists as withdrawn from 503A Category 2 (page current as of April 22, 2026) after the nominations were withdrawn. At the July 23 to 24, 2026 Pharmacy Compounding Advisory Committee meeting the committee voted against adding DSIP to the 503A bulks list, citing inadequate evidence of safety and effectiveness. Pending FDA's final action, compounding pharmacies have no basis to compound it. Not eligible for 503B outsourcing.

WADA status

WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.

Regulatory timeline

1. Jul 24, 2026PCAC

   PCAC votes against adding DSIP to the 503A bulks list

   At the July 23 to 24, 2026 meeting, the Pharmacy Compounding Advisory Committee did not recommend delta sleep-inducing peptide (DSIP) for the 503A bulks list, citing the state of the evidence. FDA makes the final determination by rulemaking.

   Regulatory: Not eligible for compoundingSource: Pharmacy Compounding Advisory Committee
2. Apr 15, 2026FDA

   FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2

   FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.

   Regulatory: Removed from Category 2 (Apr 2026)Source: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)
3. Sep 2023FDA

   FDA places a batch of nominated peptides in 503A Category 2

   In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.

   Regulatory: Not eligible for compoundingSource: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

Full tracker for DSIP (delta sleep-inducing peptide) or the category-wide tracker.

What published studies of DSIP (delta sleep-inducing peptide) used

Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.

Human trials used intravenous DSIP at approximately 25 nmol/kg (about 0.02 mg/kg) given in the evening for a small number of nights (Schneider-Helmert 1987; Monti 1987). No subcutaneous, intranasal, or oral human dose has been studied.

Routes reported

What are the side effects and interactions of DSIP (delta sleep-inducing peptide)?

Side effects

Interactions

Contraindications

How do people access DSIP (delta sleep-inducing peptide) legally?

Typical cost: Products sold as research chemicals are not lawful for human use and are not verified for identity or purity. Not available through licensed compounding or telehealth channels.

• Rules by state
• Verified provider directory

What's actually offered, and what that means for you

Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make DSIP (delta sleep-inducing peptide) lawful. DSIP (delta sleep-inducing peptide) is not FDA approved and not on the 503A bulks list, so a pharmacy has no lawful basis to compound it. [5] [8]

Enforcement is uneven. FDA mostly acts through warning letters to compounders and online sellers, Category 2 safety listings, and import alerts that let it detain shipments, rather than stopping every pharmacy. State pharmacy boards oversee pharmacies day to day, and their rules differ. [8] [9] [10] [11] [12]

What changes for you

• No FDA review of the product: FDA does not check a compounded drug's safety, effectiveness, or quality before it is sold. [12]
• Identity, purity, sterility, and dose accuracy can vary from batch to batch. [8]
• Insurance rarely covers it, so you usually pay cash.
• For tested athletes, DSIP (delta sleep-inducing peptide) is prohibited at all times on the WADA list, whatever the source. [7]

What to check

These checks lower some risks, but they do not make an unlawfully compounded product lawful or safe. Check for:

• A 503A pharmacy licensed in your state (your state board of pharmacy publishes license lookups). [12]
• A real evaluation by a licensed prescriber, not just an online form.
• A certificate of analysis for the specific batch.

Frequently asked questions

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

From the blog

• PCAC recommended six peptides. What changes and what does not

  FDA's compounding advisory committee backed BPC-157, KPV, TB-500, MOTS-c, semax, and epitalon for the 503A bulks list and rejected DSIP. Here is what the vote does and does not do.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.