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Saunatica

Peptide

DSIP (Emideltide)

  • Peptide
  • Sleep research
  • Not FDA-approved

DSIP is a nine-amino-acid peptide studied for sleep, narcolepsy, and withdrawal symptoms. Human studies exist, but they are small, decades old, inconsistent, and do not establish reliable benefit.

The basics

What is it?

DSIP stands for delta sleep-inducing peptide. Its formal name is emideltide, and it contains nine amino acids. It was first isolated from blood leaving the brain of sleeping rabbits and was later made synthetically. Researchers have not identified a specific DSIP receptor, gene, or precursor protein. Animal work suggests it may affect sleep and the body's opioid-like signaling indirectly, but direct opioid-receptor binding has not been shown.

Why it comes up

What are people interested in it for?

  • Chronic-insomnia research
  • Sleep timing and sleep structure
  • Narcolepsy research
  • Opioid-withdrawal research
  • Stress and nervous-system research

The name can make DSIP sound like an established sleep medicine, but the human studies are small and mixed. FDA considers the available findings inconclusive and, at best, preliminary.

Evidence

What does the research show?

Animal evidence

Studies in rabbits, rats, and cats reported changes in delta brain waves or non-REM sleep, but the findings were inconsistent. Some experiments affected non-REM sleep, some also affected REM sleep, and others did not reproduce the expected delta-wave effect. Animal findings also suggested possible indirect involvement of the body's endorphin or enkephalin systems. These results do not establish a clinical benefit in people.

Human evidence

FDA identified short-term intravenous exposure across several studies involving 209 people over periods of 1 to 15 days; this was not one 209-person efficacy trial. The insomnia literature includes at least two randomized, double-blind, placebo-controlled crossover reports with six people each, a 16-person double-blind placebo-controlled study, a weak 14-person external-control study, an inadequately controlled 18-person study, and several very small series involving six, four, and two people, with possible overlap between publications. The 16-person study found no meaningful overall benefit, and another controlled study concluded that any sleep improvement had little clinical importance. There are no large or modern confirmatory trials. Narcolepsy evidence is limited to one patient report. Withdrawal evidence includes an uncontrolled 107-person study and a seven-person open study in which only two people completed the planned regimen. FDA concludes that evidence is insufficient for insomnia, narcolepsy, and opioid withdrawal, and it found no clinical evidence for the proposed subcutaneous route.

Evidence grade

No formal GRADE assessment was found. Randomized studies exist, but they are extremely small, old, inconsistent, and unsupported by modern confirmatory trials. Overall human evidence is very low or insufficient, not a published letter grade.

Unknowns and risks

What about safety?

Short insomnia studies did not reveal a clear major adverse-event pattern, but they were too small and brief to establish safety. In the 107-person withdrawal study, nine people had transient sweating, headache, nausea, or vertigo. Three had more serious events involving hypotension, including one report of progressive hypotension after another injection; interpretation was complicated by withdrawal itself. FDA's FAERS search through March 3, 2024 found no reports, but that does not prove safety. Chronic or intermittent safety and safety by the proposed subcutaneous route remain unknown. FDA also found inadequate repeat-dose, genetic, reproductive, and cancer-safety evidence and identified concerns about aggregation, impurities, sterility, and immune reactions.

Regulatory status

Is it legal / FDA-approved?

  1. 1Emideltide free base and acetate are not FDA-approved, have no applicable USP/NF drug-substance monograph, and are not components of an FDA-approved drug.
  2. 2Its former 503A Category 2 nomination was withdrawn. It now appears under substances nominated but withdrawn, not current Category 2, and it is not Category 1.
  3. 3Emideltide is not on the final 503A Bulks List. The withdrawn nomination does not authorize compounding or grant Category 1 enforcement discretion.
  4. 4On July 24, 2026, PCAC reviews it for chronic insomnia, narcolepsy, and opioid withdrawal. FDA staff proposes not adding either form. PCAC advice is nonbinding, and FDA has not made its final decision.
  5. 5A federal enforcement case involving Tailor Made Compounding identified DSIP among several unapproved drugs that were distributed.
  6. 6A "research use only" label is not FDA approval or authorization for human administration.

A practical checklist

Questions to ask a licensed provider

  • How large and recent are the human studies supporting the reason I'm considering this?
  • Did the controlled studies show a meaningful difference from placebo?
  • What is known about short-term and long-term safety?
  • What is its current FDA and compounding status?
  • How would identity, purity, sterility, aggregates, and impurities be checked?
  • Are there approved options with stronger evidence for sleep or withdrawal?
  • Could my health conditions or other medications change the risks?