Investigational — Not FDA-Approved Authoritative Evidence Reference Research only (not FDA-approved)

DSIP (Delta Sleep-Inducing Peptide)

Nonapeptide first isolated from rabbit brain during induced sleep (emideltide); not approved; small human studies from the 1980s-1990s; FDA compounding-risk list: immunogenicity, no safety information for the proposed route.

Language: English العربية (Arabic) →
Drug Class Neuropeptide (nonapeptide); investigational research compound.
FDA Regulatory Status Investigational — Not FDA-Approved
Clinical Stage Research only (not FDA-approved)
Evidence Verification Active Reference Standards
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60-Second Scientific Briefing

DSIP (delta sleep-inducing peptide, emideltide) is a nine-amino-acid peptide first described in the 1970s for its link with deep sleep. It is not approved as a medicine anywhere. Human research is limited to small studies from the 1980s and 1990s; controlled studies in healthy volunteers found no effect on stimulated ACTH and cortisol or on growth hormone and prolactin. The FDA cites a risk of immunogenicity and no safety information for its proposed routes.

What is DSIP (Delta Sleep-Inducing Peptide)?

Pharmacological Classification & Molecular Identity

DSIP (emideltide) is a nine-amino-acid peptide described in the 1970s in connection with deep (delta) sleep. It has also been described as a possible inhibitor of pituitary ACTH release. [1] Psychoneuroendocrinology, 1995 ↗

Verified Chemical & Regulatory Registry Identifiers

Documented Aliases & Research Codes:
Emideltide Delta sleep-inducing peptide

Mechanism of Action & Receptor Targets

Biological Pathway and Target Binding

Receptor Selectivity: No specific receptor has been established. Human studies tested whether it changes pituitary hormones: one study in 8 men reported a fall in ACTH without a change in vasopressin, while another in healthy men found no effect on CRH-stimulated or meal-related ACTH and cortisol. [1] Psychoneuroendocrinology, 1995 ↗ [2] Horm Res, 1994 ↗

Regulatory & FDA Approval Status

Legal and Regulatory Classifications
⚠️ STRICT REGULATORY NOTICE: UNAPPROVED INVESTIGATIONAL DRUG

Not approved by the US FDA or any other regulator. In its 2026 compounding-risk list the FDA cites a risk of immunogenicity and no safety information for the proposed route of administration for emideltide (DSIP). [1] U.S. Food and Drug Administration, 2026 ↗

DSIP (Delta Sleep-Inducing Peptide) is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.

Human Evidence & Clinical Trials

Clinical Study Readouts and Evidence Syntheses

Human data are small and old. Placebo-controlled endocrine studies in healthy volunteers: no effect on CRH-stimulated or meal-related ACTH and cortisol (20 men, 1995); no effect on spontaneous or arginine-stimulated growth hormone and prolactin (8 women, 1993); a decrease in ACTH without a change in vasopressin (15 men, 1994). Sleep studies in insomnia were published in the 1980s (for example Eur Neurol 1984) without modern trial standards. No large or recent randomised trial has been published. [1] Psychoneuroendocrinology, 1995 ↗ [2] Horm Res, 1994 ↗ [3] Psychoneuroendocrinology, 1993 ↗ [4] Eur Neurol, 1984 ↗

Clinical Evidence

Human data are small and old. Placebo-controlled endocrine studies in healthy volunteers: no effect on CRH-stimulated or meal-related ACTH and cortisol (20 men, 1995); no effect on spontaneous or arginine-stimulated growth hormone and prolactin (8 women, 1993); a decrease in ACTH without a change in vasopressin (15 men, 1994). Sleep studies in insomnia were published in the 1980s (for example Eur Neurol 1984) without modern trial standards. No large or recent randomised trial has been published.

Safety Profile & Clinical Limitations

Documented Adverse Events and Known Uncertainties

There is no clinical safety dataset. The FDA cites a risk of immunogenicity and no safety information for the proposed route of administration. [1] U.S. Food and Drug Administration, 2026 ↗

ℹ️ Active Research Safety Surveillance

Its receptor, mechanism, efficacy for sleep, long-term safety and the quality of non-pharmaceutical material are unknown. [1] U.S. Food and Drug Administration, 2026 ↗

Dose Approval Status

Commercial Dosing Status and Policy Directives
🛑 NO APPROVED COMMERCIAL DOSING REGIMEN

No dose is approved or established. The amounts used in the published studies are part of each study's design and are described in the linked papers; they are not a recommendation. [1] U.S. Food and Drug Administration, 2026 ↗

Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.

Storage & Handling Status: There is no approved product label, so no official storage instructions exist.

What is Known vs. What is Unknown

Evidence Comparison and Clinical Evidence Boundaries

✓ Confirmed Scientific Evidence

  • DSIP (emideltide) is a nine-amino-acid peptide described in the 1970s in connection with deep (delta) sleep. It has also been described as a possible inhibitor of pituitary ACTH release.
  • Targets & Selectivity: No specific receptor has been established. Human studies tested whether it changes pituitary hormones: one study in 8 men reported a fall in ACTH without a change in vasopressin, while another in healthy men found no effect on CRH-stimulated or meal-related ACTH and cortisol.
  • Human data are small and old. Placebo-controlled endocrine studies in healthy volunteers: no effect on CRH-stimulated or meal-related ACTH and cortisol (20 men, 1995); no effect on spontaneous or arginine-stimulated growth hormone and prolactin (8 women, 1993); a decrease in ACTH without a change in vasopressin (15 men, 1994). Sleep studies in insomnia were published in the 1980s (for example Eur Neurol 1984) without modern trial standards. No large or recent randomised trial has been published.
  • Safety considerations: There is no clinical safety dataset. The FDA cites a risk of immunogenicity and no safety information for the proposed route of administration.

? Unknown / Under Ongoing Investigation

  • Its receptor, mechanism, efficacy for sleep, long-term safety and the quality of non-pharmaceutical material are unknown.

Verified Questions & Answers

10 Verified scientific answers with permanent anchor keys
#1

What is DSIP (Delta Sleep-Inducing Peptide) and how is it classified?

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Direct Answer

DSIP (emideltide) is a nine-amino-acid peptide described in the 1970s in connection with deep sleep. It is a research compound and is not approved as a medicine.

#2

What is the mechanism of action and receptor profile of DSIP (Delta Sleep-Inducing Peptide)?

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Direct Answer

No specific receptor has been established. Human studies on pituitary hormones were inconsistent: one reported lower ACTH, another found no effect on ACTH and cortisol.

#3

Is DSIP (Delta Sleep-Inducing Peptide) approved by the US FDA or health authorities?

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Direct Answer

No. DSIP is not approved anywhere. The FDA cites a risk of immunogenicity and no safety information for its proposed route.

Authoritative Citations:
#4

What human clinical evidence and trials exist for DSIP (Delta Sleep-Inducing Peptide)?

§
Direct Answer

Only small studies from the 1980s and 1990s. Controlled studies in healthy volunteers found no effect on stimulated ACTH and cortisol or on growth hormone and prolactin. No large or recent randomised trial exists.

Psychoneuroendocrinology 1995: in healthy men, intravenous DSIP vs placebo did not change ACTH and cortisol responses to CRH (5 men per condition) or the meal-related midday ACTH and cortisol surge (10 men); the authors concluded their data do not support an inhibitory role on ACTH in humans. Psychoneuroendocrinology 1993: in 8 healthy women, DSIP did not change spontaneous or arginine-stimulated growth hormone and prolactin, or their daily rhythm. Horm Res 1994: in healthy men, DSIP lowered ACTH but did not change vasopressin at rest or after osmotic or postural stimulation. Insomnia studies were published in the 1980s (Eur Neurol 1984) without modern randomised-trial standards.

#5

What adverse effects and safety risks are documented for DSIP (Delta Sleep-Inducing Peptide)?

§
Direct Answer

There is no clinical safety dataset. The FDA cites a risk of immunogenicity and no safety information for the proposed route.

Authoritative Citations:
#6

What are the critical unknown safety aspects and clinical limitations of DSIP (Delta Sleep-Inducing Peptide)?

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Direct Answer

Its receptor, mechanism, effect on sleep, long-term safety and the quality of non-pharmaceutical material are unknown.

Authoritative Citations:
#7

What is the approved dosing status for DSIP (Delta Sleep-Inducing Peptide)?

§
Direct Answer

No dose is approved or established. The amounts used in the published studies are part of each study's design and are described in the linked papers; they are not a recommendation.

Authoritative Citations:
#8

What are the storage and handling requirements for DSIP (Delta Sleep-Inducing Peptide)?

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Direct Answer

There is no approved product label, so no official storage instructions exist.

#9

Is DSIP (Delta Sleep-Inducing Peptide) prohibited in competitive sports by WADA?

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Direct Answer

It is not named individually on the 2026 WADA Prohibited List. Under section S0 (non-approved substances), any pharmacological substance without a current approval by a government health authority for human therapeutic use is prohibited at all times. Athletes should confirm with their national anti-doping organisation.

Authoritative Citations:
#10

What is Egypt Peptides' official medical policy regarding DSIP (Delta Sleep-Inducing Peptide)?

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Direct Answer

Egypt Peptides publishes reviewed scientific reference monographs for documentation and research. The site does not give individual medical advice, preparation or injection instructions, combination protocols or off-label use instructions. Decisions about any medicine belong to the treating physician.

Authoritative Citations:

Authoritative Sources & Literature Registry

Regulatory dossiers, clinical trial registries, and published studies
Source [1] Tier 1 Regulatory / Academic

Certain bulk drug substances for use in compounding that may present significant safety risks ↗

Publisher / Registry: U.S. Food and Drug Administration Publication Date: 2026-04-22
Verified Locator: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
Source [2] Tier 1 Regulatory / Academic

Delta-sleep-inducing peptide does not affect CRH and meal-induced ACTH and cortisol secretion ↗

Publisher / Registry: Psychoneuroendocrinology Publication Date: 1995-01-01 PubMed PMID: 7777652
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/7777652/
Source [3] Tier 1 Regulatory / Academic

Different effects of delta-sleep-inducing peptide on arginine-vasopressin and ACTH secretion in normal men ↗

Publisher / Registry: Horm Res Publication Date: 1994-01-01 PubMed PMID: 7698722
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/7698722/
Source [4] Tier 1 Regulatory / Academic

Delta sleep-inducing peptide administration does not influence growth hormone and prolactin secretion in normal women ↗

Publisher / Registry: Psychoneuroendocrinology Publication Date: 1993-01-01 PubMed PMID: 8475226
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/8475226/
Source [5] Tier 1 Regulatory / Academic

DSIP in insomnia ↗

Publisher / Registry: Eur Neurol Publication Date: 1984-01-01 PubMed PMID: 6391925
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/6391925/

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