Regulatory status

Status at a glance

503A compounding status

Not nominated

We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.

Status recorded · FDA source document

Also known as
Delta Sleep-Inducing Peptide
FDA approval
Not FDA-approved for any use
503B outsourcing
Not determined
Anti-doping (WADA)
Not on the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.

This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.

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Status as of

Key takeaway

DSIP (delta sleep-inducing peptide) is a naturally occurring peptide sold on the "research peptide" market for sleep and stress. Its human evidence is limited to a few small, dated, inconsistent studies, and no validated mechanism or reproducible benefit has been established. As of 2026 it is not FDA-approved and not approved as a drug anywhere.

At a glance

FDA status
Non-FDA-approved peptide sold in the wellness/gray market
What it is
Naturally occurring nine-amino acid peptide linked in early research to sleep
Research
Human evidence is sparse, old, and inconsistent; no mechanism is validated
Approval status
Not approved as a drug in any country
Evidence strength
Low research

Summary

DSIP is a naturally occurring nine-amino-acid peptide linked to sleep in early research. Learn its history, what studies show, and its unapproved status.

What is DSIP?

DSIP, delta sleep-inducing peptide, is a naturally occurring nine-amino acid peptide first isolated decades ago from the blood of sleeping rabbits. It is sold through wellness and "research peptide" channels for sleep and stress, though its role in the body is still not well understood. It is not an approved medicine.

What is the history of DSIP?

DSIP was discovered in the 1970s out of a long-standing question in sleep science: whether sleep is driven by a chemical that circulates in the blood. Working in Switzerland, the physiologist Marcel Monnier and colleagues ran cross-circulation experiments in rabbits, electrically stimulating a sleep-related region of the brain in one animal and passing its blood to a second, which then showed the slow, high-amplitude "delta" brain waves of deep sleep. That pointed to a sleep-promoting substance carried in the blood.

In 1977, Guido Schoenenberger, Monnier, and their co-workers isolated and synthesized that substance, a nine-amino-acid peptide they named delta sleep-inducing peptide after the delta-wave sleep it was linked to. Having a synthetic version made the peptide available for wider study.

Over the following decades, researchers looked beyond sleep, exploring possible roles in stress, body temperature, pain, and antioxidant activity, but the findings never converged into a validated mechanism or an approved therapy. DSIP was later shown to occur naturally in humans as well as animals. Despite nearly fifty years of study, it remains an experimental compound rather than a medicine, sold today through wellness and "research peptide" channels.

How does it work?

DSIP has been proposed to play roles in:

  • Regulating sleep
  • Modulating the body's stress (HPA-axis) responses
  • Acting as an antioxidant

It has no validated receptor or defined mechanism. The sleep association that gave it its name comes from early animal work that has not resolved into a clear understanding of how, or whether, it influences human sleep. This describes a proposed mechanism, separate from any demonstrated benefit.

Is it FDA-approved?

Safety note

Status: Non-FDA-approved peptide sold in the wellness/gray market

Category: Wellness and performance · Primary body area: Brain & sleep

No. DSIP is not approved by the FDA and is not approved as a drug in any country; it is sold only through research and gray-market channels and is not on FDA compounding lists. As a neutral regulatory note, a related sleep compound was reviewed at a 2026 FDA compounding advisory meeting and received an unfavorable vote.

What does the research show?

Editor’s note

Evidence strength: Low research

The human data are limited to sparse, dated, low-quality studies without reproducible efficacy, and no mechanism has been validated.

The human evidence is thin and old. A small number of studies from the 1980s and 1990s examined DSIP in insomnia, chronic pain, and withdrawal states and reported inconsistent findings; most were small and uncontrolled, and no modern, well-conducted trials have established a reproducible benefit. There is no sound human evidence that DSIP improves sleep or stress.

Sources: the small human studies of DSIP from the 1980s are indexed on PubMed, including a double-blind insomnia study (Schneider-Helmert & Schoenenberger, 1981, DOI 10.1007/BF01971753), a chronic-pain pilot study (Larbig et al., 1984, DOI 10.1159/000115716), and an open-label alcohol- and opiate-withdrawal study (Dick et al., 1984, DOI 10.1159/000115715); and reference literature on therapeutic peptides noting its preclinical status (Journal of the AAOS Global Research & Reviews, 2025, DOI: 10.5435/JAAOSGlobal-D-25-00236). This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.

Registered human trials

0 registered human trials on ClinicalTrials.gov that we reviewed

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