DSIP
DSIP, also called emideltide, is the nonapeptide WAGGDASGE. A 14-person controlled study reported better sleep and daytime function, while two other small insomnia studies found little or weak benefit. A later Russian report measured an electrophysiology surrogate in diabetic retinopathy. No study establishes a reproducible insomnia treatment, a validated receptor, or long-term safety.
delta sleep-inducing nonapeptide
- Sequence WAGGDASGE
- Also called emideltide
- Controlled insomnia studies produced mixed or weak findings
- A Russian diabetic-retinopathy report measured an electrophysiology surrogate
- No established molecular receptor or approved drug
What is DSIP?
DSIP is the nine-amino-acid peptide WAGGDASGE, also called emideltide. Its name came from the original sleep-induction claim, but later studies did not establish a selective hypnotic action.
Insomnia study · 14 patients
Small controlled clinical study
Schneider-Helmert D. European Neurology, 1987.
Fourteen middle-aged people with chronic insomnia received DSIP under placebo-controlled, double-blind conditions for seven successive nights. The authors reported better nighttime sleep, daytime alertness, and performance, but the sample was tiny, the placebo periods served as baseline and post-treatment measurements, and the cited records contain no modern replication.
- Participants / model
- 14 middle-aged adults with chronic insomnia
- Treatment
- Nightly DSIP under placebo-controlled conditions
- Follow-up
- Seven nights plus one placebo post-treatment night
- Study design
- Double-blind study with placebo baseline and post-treatment measurements
FDA 2026 briefing · evidence review
FDA staff briefing document
US Food and Drug Administration, July 2026.
FDA staff reviewed the sparse older studies, unresolved pharmacology, and safety gaps and recommended against 503A bulks-list inclusion. The advisory process did not approve DSIP.
- Study design
- Regulatory evidence review
Does DSIP treat insomnia?
The controlled insomnia record is mixed and too small to establish treatment. A 14-person study reported improvement, while a separate double-blind crossover found little clinically meaningful change and a 16-person parallel study found weak effects without better subjective sleep quality.
Did other human studies confirm a sleep mechanism?
No. The other cited experiments mainly measured acute pituitary or adrenal hormones in 8 to 15 healthy volunteers. They did not test insomnia outcomes.
Endocrine study · 11 volunteers
Human pharmacology study
Graf MV et al. Neuroendocrinology, 1989.
Eleven healthy volunteers received intravenous DSIP. An ACTH-related signal decreased while cortisol did not significantly change; the study measured an acute endocrine response, not sleep or clinical benefit.
- Participants / model
- 11 healthy adults
- Treatment
- Intravenous DSIP, 25 nmol/kg
- Study design
- Acute endocrine-response study
Healthy women · no GH or prolactin change
Human pharmacology study
Tissot R et al. Neuropsychobiology, 1993.
Eight healthy women received intravenous DSIP. The investigators did not find a significant effect on growth hormone or prolactin in the measured window.
- Participants / model
- Eight healthy women
- Treatment
- Intravenous DSIP
- Study design
- Acute endocrine-response experiment
Endocrine study · 15 participants
Human pharmacology study
Graf MV et al. Neuropsychobiology, 1992.
Fifteen healthy volunteers were studied for acute neuroendocrine responses after DSIP. The small physiological experiment did not establish an insomnia or recovery outcome.
- Participants / model
- 15 healthy adults
- Treatment
- Acute DSIP exposure
- Study design
- Small endocrine-response study
What did the Russian diabetic-retinopathy report show?
Fifteen patients with diabetic retinopathy received intranasal deltalicin for two months and showed a shorter visual-evoked-potential recovery time after photostress. The abstract does not describe a concurrent untreated retinopathy arm or a patient-centered vision outcome, so it does not establish treatment of retinopathy, insomnia, or general neuroprotection.
Russian clinical report · 15 treated patients
Clinical report
Kresiun NV, Godlevskii LS. Eksperimentalnaia i Klinicheskaia Farmakologiia, 2014. Article in Russian with English abstract.
The study measured visual evoked potentials after retinal photostress in 15 healthy volunteers, 15 patients with type 1 diabetes without retinopathy, and 15 with diabetic retinopathy. The retinopathy group received intranasal deltalicin, described as 0.0003 g DSIP daily for two months. Mean recovery time was reported to fall from 137.2 seconds before treatment to 95.1 seconds after treatment. The abstract does not describe a randomized or concurrent untreated retinopathy comparator, visual acuity benefit, masking, or adverse-event data.
- Participants / model
- 15 healthy volunteers, 15 patients with diabetes without retinopathy, and 15 patients with diabetic retinopathy
- Treatment
- Intranasal deltalicin containing 0.0003 g DSIP daily in the retinopathy group
- Follow-up
- Two months
- Study design
- Russian-language clinical before-and-after report with comparison groups for baseline physiology, but no concurrent untreated retinopathy arm described
What about the Russian Deltaran diabetes pilot?
It was an uncontrolled 11-person before-and-after study of a DSIP-containing product with many questionnaire, metabolic, and hormone outcomes. The product was not characterized well enough to isolate DSIP, so the report cannot establish an exact-peptide sleep or diabetes effect.
Russian pilot · 11 people, DSIP-containing product
Uncontrolled clinical report
Odin VI et al. Advances in Gerontology, 2004. Article in Russian with English abstract.
Eleven elderly people with diabetes received a product described only as DSIP-containing Deltaran and were assessed before and 60 days after treatment. The abstract reports changes in questionnaire items, sleep, post-load glucose, and several hormones, with many other measures nonsignificant. It provides no concurrent comparator, product composition sufficient to isolate DSIP, multiplicity correction, attrition account, or adverse-event denominator.
- Participants / model
- 11 elderly people with diabetes
- Treatment
- Deltaran, described as a DSIP-containing product; exact composition and a reliable regimen are not established by the abstract
- Follow-up
- Before-and-after assessment over 60 days
- Study design
- Russian-language uncontrolled pilot with multiple outcomes
This combination-product pilot cannot be assigned to exact DSIP monotherapy.
Read the original sourceInsomnia study · 14 patients
Small controlled clinical study
Schneider-Helmert D. European Neurology, 1987.
Fourteen middle-aged people with chronic insomnia received DSIP under placebo-controlled, double-blind conditions for seven successive nights. The authors reported better nighttime sleep, daytime alertness, and performance, but the sample was tiny, the placebo periods served as baseline and post-treatment measurements, and the cited records contain no modern replication.
- Participants / model
- 14 middle-aged adults with chronic insomnia
- Treatment
- Nightly DSIP under placebo-controlled conditions
- Follow-up
- Seven nights plus one placebo post-treatment night
- Study design
- Double-blind study with placebo baseline and post-treatment measurements
Insomnia crossover · little clinical significance
Small controlled clinical study
Monti JM et al. International Journal of Clinical Pharmacology Research, 1987.
People with chronic insomnia received intravenous DSIP at 25 nmol/kg or placebo during four nights in a double-blind crossover design. Several sleep measures moved during DSIP exposure, but most did not differ significantly from baseline or placebo. The two significant stage-2 measures were already imbalanced at baseline, and the authors judged the improvement of little clinical significance.
- Participants / model
- Adults with chronic insomnia; denominator not stated in the PubMed abstract
- Treatment
- Intravenous DSIP 25 nmol/kg or placebo
- Follow-up
- Four nights
- Study design
- Double-blind placebo crossover
Insomnia trial · 16 patients, weak findings
Small randomized clinical study
Bes F et al. Neuropsychobiology, 1992.
Sixteen people with chronic insomnia were matched into parallel DSIP and glucose-placebo groups. Intravenous DSIP was given before three laboratory nights. Sleep efficiency and latency favored DSIP, but the authors said the effects were weak, partly compatible with an incidental placebo-group change, and unlikely to provide major therapeutic benefit; subjective sleep quality did not improve.
- Participants / model
- 16 adults with chronic insomnia
- Treatment
- Intravenous DSIP 25 nmol/kg or glucose placebo
- Follow-up
- Three treatment nights after adaptation and baseline nights
- Study design
- Double-blind matched-pairs parallel-group study
How is DSIP supposed to work?
A single validated DSIP receptor and causal human sleep pathway have not been established. Small endocrine experiments produced mixed signals, and a 24-person anesthesia study showed lighter rather than deeper measured anesthesia at one dose. Claims about cortisol control, growth hormone, stress resilience, or recovery remain unproven.
No validated receptor or endogenous sleep-switch role has been established. A change in one sleep experiment does not establish a clinically useful hypnotic.
Endocrine study · 11 volunteers
Human pharmacology study
Graf MV et al. Neuroendocrinology, 1989.
Eleven healthy volunteers received intravenous DSIP. An ACTH-related signal decreased while cortisol did not significantly change; the study measured an acute endocrine response, not sleep or clinical benefit.
- Participants / model
- 11 healthy adults
- Treatment
- Intravenous DSIP, 25 nmol/kg
- Study design
- Acute endocrine-response study
Healthy women · no GH or prolactin change
Human pharmacology study
Tissot R et al. Neuropsychobiology, 1993.
Eight healthy women received intravenous DSIP. The investigators did not find a significant effect on growth hormone or prolactin in the measured window.
- Participants / model
- Eight healthy women
- Treatment
- Intravenous DSIP
- Study design
- Acute endocrine-response experiment
Anesthesia RCT · 24 women, autonomic signal
Randomized human pharmacology study
Pomfrett CJ et al. European Journal of Anaesthesiology, 2009.
Twenty-four women undergoing isoflurane anesthesia were randomized to saline or one of three intravenous DSIP doses. DSIP increased heart rate, decreased heart-rate variability, reduced delta rhythm and burst suppression, and increased bispectral index at the lowest dose, consistent with lighter rather than deeper measured anesthesia. With only three DSIP dose groups totaling 12 participants, it cannot quantify event rates or routine-use safety.
- Participants / model
- 24 women classified ASA I or II; 12 saline and 12 divided across three DSIP doses
- Treatment
- Intravenous DSIP 25, 50, or 100 nmol/kg, administered awake and again during isoflurane anesthesia
- Study design
- Randomized controlled dose-ranging human pharmacology study
FDA 2026 briefing · evidence review
FDA staff briefing document
US Food and Drug Administration, July 2026.
FDA staff reviewed the sparse older studies, unresolved pharmacology, and safety gaps and recommended against 503A bulks-list inclusion. The advisory process did not approve DSIP.
- Study design
- Regulatory evidence review
What safety information exists?
The cited sleep and endocrine studies each enrolled fewer than 25 people, most exposure was brief, and the Russian reports gave little adverse-event detail. In the anesthesia study, DSIP increased heart rate and reduced heart-rate variability. The record cannot characterize uncommon events, repeated use, immune reactions, pregnancy, interactions with sedatives, next-day impairment, or current product quality.
- Sedative combinations: interaction data with alcohol, benzodiazepines, antihistamines, sleep drugs, or opioids were not found.
- Anesthesia: one small trial found autonomic and EEG changes and lighter measured anesthesia rather than a simple sedative effect.
- Route: old intravenous or nightly-injection experiments do not validate intranasal or chronic protocols.
- Product quality: identity, sterility, endotoxin, potency, and degradation remain product-specific.
Insomnia study · 14 patients
Small controlled clinical study
Schneider-Helmert D. European Neurology, 1987.
Fourteen middle-aged people with chronic insomnia received DSIP under placebo-controlled, double-blind conditions for seven successive nights. The authors reported better nighttime sleep, daytime alertness, and performance, but the sample was tiny, the placebo periods served as baseline and post-treatment measurements, and the cited records contain no modern replication.
- Participants / model
- 14 middle-aged adults with chronic insomnia
- Treatment
- Nightly DSIP under placebo-controlled conditions
- Follow-up
- Seven nights plus one placebo post-treatment night
- Study design
- Double-blind study with placebo baseline and post-treatment measurements
Insomnia crossover · little clinical significance
Small controlled clinical study
Monti JM et al. International Journal of Clinical Pharmacology Research, 1987.
People with chronic insomnia received intravenous DSIP at 25 nmol/kg or placebo during four nights in a double-blind crossover design. Several sleep measures moved during DSIP exposure, but most did not differ significantly from baseline or placebo. The two significant stage-2 measures were already imbalanced at baseline, and the authors judged the improvement of little clinical significance.
- Participants / model
- Adults with chronic insomnia; denominator not stated in the PubMed abstract
- Treatment
- Intravenous DSIP 25 nmol/kg or placebo
- Follow-up
- Four nights
- Study design
- Double-blind placebo crossover
Insomnia trial · 16 patients, weak findings
Small randomized clinical study
Bes F et al. Neuropsychobiology, 1992.
Sixteen people with chronic insomnia were matched into parallel DSIP and glucose-placebo groups. Intravenous DSIP was given before three laboratory nights. Sleep efficiency and latency favored DSIP, but the authors said the effects were weak, partly compatible with an incidental placebo-group change, and unlikely to provide major therapeutic benefit; subjective sleep quality did not improve.
- Participants / model
- 16 adults with chronic insomnia
- Treatment
- Intravenous DSIP 25 nmol/kg or glucose placebo
- Follow-up
- Three treatment nights after adaptation and baseline nights
- Study design
- Double-blind matched-pairs parallel-group study
Russian clinical report · 15 treated patients
Clinical report
Kresiun NV, Godlevskii LS. Eksperimentalnaia i Klinicheskaia Farmakologiia, 2014. Article in Russian with English abstract.
The study measured visual evoked potentials after retinal photostress in 15 healthy volunteers, 15 patients with type 1 diabetes without retinopathy, and 15 with diabetic retinopathy. The retinopathy group received intranasal deltalicin, described as 0.0003 g DSIP daily for two months. Mean recovery time was reported to fall from 137.2 seconds before treatment to 95.1 seconds after treatment. The abstract does not describe a randomized or concurrent untreated retinopathy comparator, visual acuity benefit, masking, or adverse-event data.
- Participants / model
- 15 healthy volunteers, 15 patients with diabetes without retinopathy, and 15 patients with diabetic retinopathy
- Treatment
- Intranasal deltalicin containing 0.0003 g DSIP daily in the retinopathy group
- Follow-up
- Two months
- Study design
- Russian-language clinical before-and-after report with comparison groups for baseline physiology, but no concurrent untreated retinopathy arm described
Russian pilot · 11 people, DSIP-containing product
Uncontrolled clinical report
Odin VI et al. Advances in Gerontology, 2004. Article in Russian with English abstract.
Eleven elderly people with diabetes received a product described only as DSIP-containing Deltaran and were assessed before and 60 days after treatment. The abstract reports changes in questionnaire items, sleep, post-load glucose, and several hormones, with many other measures nonsignificant. It provides no concurrent comparator, product composition sufficient to isolate DSIP, multiplicity correction, attrition account, or adverse-event denominator.
- Participants / model
- 11 elderly people with diabetes
- Treatment
- Deltaran, described as a DSIP-containing product; exact composition and a reliable regimen are not established by the abstract
- Follow-up
- Before-and-after assessment over 60 days
- Study design
- Russian-language uncontrolled pilot with multiple outcomes
This combination-product pilot cannot be assigned to exact DSIP monotherapy.
Read the original sourceAnesthesia RCT · 24 women, autonomic signal
Randomized human pharmacology study
Pomfrett CJ et al. European Journal of Anaesthesiology, 2009.
Twenty-four women undergoing isoflurane anesthesia were randomized to saline or one of three intravenous DSIP doses. DSIP increased heart rate, decreased heart-rate variability, reduced delta rhythm and burst suppression, and increased bispectral index at the lowest dose, consistent with lighter rather than deeper measured anesthesia. With only three DSIP dose groups totaling 12 participants, it cannot quantify event rates or routine-use safety.
- Participants / model
- 24 women classified ASA I or II; 12 saline and 12 divided across three DSIP doses
- Treatment
- Intravenous DSIP 25, 50, or 100 nmol/kg, administered awake and again during isoflurane anesthesia
- Study design
- Randomized controlled dose-ranging human pharmacology study
FDA safety page · insufficient route safety
FDA safety communication
US Food and Drug Administration.
FDA identifies inadequate safety information for proposed compounded routes and cites immunogenicity and peptide-impurity concerns for emideltide.
- Study design
- Agency safety summary
Is DSIP an approved sleep treatment?
FDA approval records contain no DSIP or emideltide drug. FDA staff recommended against 503A bulks-list inclusion in July 2026; the advisory review did not approve it.
FDA safety page · insufficient route safety
FDA safety communication
US Food and Drug Administration.
FDA identifies inadequate safety information for proposed compounded routes and cites immunogenicity and peptide-impurity concerns for emideltide.
- Study design
- Agency safety summary
FDA 2026 briefing · evidence review
FDA staff briefing document
US Food and Drug Administration, July 2026.
FDA staff reviewed the sparse older studies, unresolved pharmacology, and safety gaps and recommended against 503A bulks-list inclusion. The advisory process did not approve DSIP.
- Study design
- Regulatory evidence review
Studies and sources
Insomnia study · 14 patients
Small controlled clinical study
Schneider-Helmert D. European Neurology, 1987.
Fourteen middle-aged people with chronic insomnia received DSIP under placebo-controlled, double-blind conditions for seven successive nights. The authors reported better nighttime sleep, daytime alertness, and performance, but the sample was tiny, the placebo periods served as baseline and post-treatment measurements, and the cited records contain no modern replication.
- Participants / model
- 14 middle-aged adults with chronic insomnia
- Treatment
- Nightly DSIP under placebo-controlled conditions
- Follow-up
- Seven nights plus one placebo post-treatment night
- Study design
- Double-blind study with placebo baseline and post-treatment measurements
Insomnia crossover · little clinical significance
Small controlled clinical study
Monti JM et al. International Journal of Clinical Pharmacology Research, 1987.
People with chronic insomnia received intravenous DSIP at 25 nmol/kg or placebo during four nights in a double-blind crossover design. Several sleep measures moved during DSIP exposure, but most did not differ significantly from baseline or placebo. The two significant stage-2 measures were already imbalanced at baseline, and the authors judged the improvement of little clinical significance.
- Participants / model
- Adults with chronic insomnia; denominator not stated in the PubMed abstract
- Treatment
- Intravenous DSIP 25 nmol/kg or placebo
- Follow-up
- Four nights
- Study design
- Double-blind placebo crossover
Insomnia trial · 16 patients, weak findings
Small randomized clinical study
Bes F et al. Neuropsychobiology, 1992.
Sixteen people with chronic insomnia were matched into parallel DSIP and glucose-placebo groups. Intravenous DSIP was given before three laboratory nights. Sleep efficiency and latency favored DSIP, but the authors said the effects were weak, partly compatible with an incidental placebo-group change, and unlikely to provide major therapeutic benefit; subjective sleep quality did not improve.
- Participants / model
- 16 adults with chronic insomnia
- Treatment
- Intravenous DSIP 25 nmol/kg or glucose placebo
- Follow-up
- Three treatment nights after adaptation and baseline nights
- Study design
- Double-blind matched-pairs parallel-group study
Russian clinical report · 15 treated patients
Clinical report
Kresiun NV, Godlevskii LS. Eksperimentalnaia i Klinicheskaia Farmakologiia, 2014. Article in Russian with English abstract.
The study measured visual evoked potentials after retinal photostress in 15 healthy volunteers, 15 patients with type 1 diabetes without retinopathy, and 15 with diabetic retinopathy. The retinopathy group received intranasal deltalicin, described as 0.0003 g DSIP daily for two months. Mean recovery time was reported to fall from 137.2 seconds before treatment to 95.1 seconds after treatment. The abstract does not describe a randomized or concurrent untreated retinopathy comparator, visual acuity benefit, masking, or adverse-event data.
- Participants / model
- 15 healthy volunteers, 15 patients with diabetes without retinopathy, and 15 patients with diabetic retinopathy
- Treatment
- Intranasal deltalicin containing 0.0003 g DSIP daily in the retinopathy group
- Follow-up
- Two months
- Study design
- Russian-language clinical before-and-after report with comparison groups for baseline physiology, but no concurrent untreated retinopathy arm described
Russian pilot · 11 people, DSIP-containing product
Uncontrolled clinical report
Odin VI et al. Advances in Gerontology, 2004. Article in Russian with English abstract.
Eleven elderly people with diabetes received a product described only as DSIP-containing Deltaran and were assessed before and 60 days after treatment. The abstract reports changes in questionnaire items, sleep, post-load glucose, and several hormones, with many other measures nonsignificant. It provides no concurrent comparator, product composition sufficient to isolate DSIP, multiplicity correction, attrition account, or adverse-event denominator.
- Participants / model
- 11 elderly people with diabetes
- Treatment
- Deltaran, described as a DSIP-containing product; exact composition and a reliable regimen are not established by the abstract
- Follow-up
- Before-and-after assessment over 60 days
- Study design
- Russian-language uncontrolled pilot with multiple outcomes
This combination-product pilot cannot be assigned to exact DSIP monotherapy.
Read the original sourceAnesthesia RCT · 24 women, autonomic signal
Randomized human pharmacology study
Pomfrett CJ et al. European Journal of Anaesthesiology, 2009.
Twenty-four women undergoing isoflurane anesthesia were randomized to saline or one of three intravenous DSIP doses. DSIP increased heart rate, decreased heart-rate variability, reduced delta rhythm and burst suppression, and increased bispectral index at the lowest dose, consistent with lighter rather than deeper measured anesthesia. With only three DSIP dose groups totaling 12 participants, it cannot quantify event rates or routine-use safety.
- Participants / model
- 24 women classified ASA I or II; 12 saline and 12 divided across three DSIP doses
- Treatment
- Intravenous DSIP 25, 50, or 100 nmol/kg, administered awake and again during isoflurane anesthesia
- Study design
- Randomized controlled dose-ranging human pharmacology study
Endocrine study · 11 volunteers
Human pharmacology study
Graf MV et al. Neuroendocrinology, 1989.
Eleven healthy volunteers received intravenous DSIP. An ACTH-related signal decreased while cortisol did not significantly change; the study measured an acute endocrine response, not sleep or clinical benefit.
- Participants / model
- 11 healthy adults
- Treatment
- Intravenous DSIP, 25 nmol/kg
- Study design
- Acute endocrine-response study
Healthy women · no GH or prolactin change
Human pharmacology study
Tissot R et al. Neuropsychobiology, 1993.
Eight healthy women received intravenous DSIP. The investigators did not find a significant effect on growth hormone or prolactin in the measured window.
- Participants / model
- Eight healthy women
- Treatment
- Intravenous DSIP
- Study design
- Acute endocrine-response experiment
Endocrine study · 15 participants
Human pharmacology study
Graf MV et al. Neuropsychobiology, 1992.
Fifteen healthy volunteers were studied for acute neuroendocrine responses after DSIP. The small physiological experiment did not establish an insomnia or recovery outcome.
- Participants / model
- 15 healthy adults
- Treatment
- Acute DSIP exposure
- Study design
- Small endocrine-response study
FDA safety page · insufficient route safety
FDA safety communication
US Food and Drug Administration.
FDA identifies inadequate safety information for proposed compounded routes and cites immunogenicity and peptide-impurity concerns for emideltide.
- Study design
- Agency safety summary
FDA 2026 briefing · evidence review
FDA staff briefing document
US Food and Drug Administration, July 2026.
FDA staff reviewed the sparse older studies, unresolved pharmacology, and safety gaps and recommended against 503A bulks-list inclusion. The advisory process did not approve DSIP.
- Study design
- Regulatory evidence review
Why is DSIP in C tier?
The C grade reflects a small, mixed record of administered-human studies from 1987 to 1994. Those studies do not establish a modern sleep treatment or show that current injected products match the historical material.