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Neuropeptides

DSIP (Delta Sleep-Inducing Peptide)

Also known as Delta Sleep-Inducing Peptide, DSIP, emideltide, emideltide (free base), emideltide acetate, Delta Sleeping Inducing Peptide

Limited human dataThe C_human_limited tier applies to the IV human data only. The subcutaneous practice block has no human evidence, and its confidence is low.

Endogenous neuropeptide (nonapeptide) and investigational sleep-modulating agent. No FDA-approved product exists.

Not FDA-approved. Not on FDA's 503A category lists (May 14, 2026). Source, May 14, 2026

Identity. DSIP is the common name for emideltide, a naturally occurring nonapeptide (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu; C35H48N10O15; MW 848.8 g/mol per the FDA briefing). Emideltide is not a USAN. FDA found that the nominators did not say whether they meant free base or acetate, and vendors sell both under one name. The formulary's 5 mg vial may be either, so confirm the salt form and peptide content on the pharmacy certificate of analysis. DSIP is not the same as the DSIP fusion constructs (DSIP-CBBBP, PHD fusion protein) in the mouse literature, or Deltaran (a Russian emideltide-glycine product). Do not apply Deltalicin data (a Russian intranasal DSIP product) to the vial.

At a glance

These dosages are a helpful guide, not a prescription. Every clinician is expected to do their own due diligence before prescribing.

  1. Start

    25 nmol/kg IV per dose (most studied regimen)123

    Human study
Frequency
Once daily, afternoon before each treatment night3
Route
Intravenous (slow infusion)1
Course
3 treatment nights (5 nights total in lab)3
Trial doses are IV nmol/kg; no human subcutaneous data exist, so never transpose them onto a flat SC mcg dose.
Calculate this dose

Dosing detail

Human studies

Human study

  • Healthy volunteers, first-in-human pilot, double-blind placebo crossover; morning infusion

    25 nmol/kg1

    Route
    Intravenous (slow infusion)
    Frequency
    Single dose per experimental day (placebo vs DSIP on consecutive days)
    Duration
    1 day per arm; effects on following night observed
    n
    6 (abstract: "six normal volunteers (four males and two females)")
    Design
    Double-blind, placebo-controlled crossover
    Source quote
    DSIP was applied as slow intravenous infusions at a dosage of 25 nmol/kg in the morning. The subjects immediately reported a feeling of sleep pressure, and sleep increased by 59% (median of total sleep time) within a 130-min interval after the treatment as compared with placebo.

    Finding. Sleep pressure and longer total sleep in the following 130 min vs placebo, with no classic sedation. The authors reported good tolerability.

  • Chronic insomniacs, middle-aged; acute single administration

    25 nmoles/kg b.wt2

    Route
    Intravenous
    Frequency
    Single IV dose immediately before bedtime on each DSIP night (over 4 minutes per FDA)
    Duration
    Three test nights in a randomized crossover (placebo-DSIP-placebo or DSIP-placebo-DSIP); effects followed up to 6 h of night sleep each (FDA briefing)
    n
    6 (abstract: "6 middle-aged chronic insomniacs")
    Design
    Double-blind, polysomnography
    Source quote
    The effects of acute intravenous administration of synthetic DSIP, 25 nmoles/kg b.wt, on disturbed human sleep were tested in 6 middle-aged chronic insomniacs. The results were: longer sleep duration and a higher quality of sleep with fewer interruptions

    Finding. Longer sleep duration and fewer interruptions for up to 6 h. A slight arousing effect occurred in the first hour, with sleep promotion in the second hour.

  • Chronic insomniac patients, afternoon dosing before nights 3-5

    25 nmol/kg body weight3

    Route
    Intravenous
    Frequency
    Once daily, afternoon before each of 3 nights
    Duration
    3 treatment nights (5 nights total in lab)
    n
    16 (abstract: "16 chronic insomniac patients"; half received DSIP)
    Design
    Double-blind, matched-pairs, parallel-group, glucose placebo (RCT)
    Source quote
    In the afternoon before the 3rd, 4th and 5th night, half of the patients received intravenously 25 nmol/kg body weight DSIP, and half of the patients a glucose solution (placebo).

    Finding. Higher sleep efficiency and shorter latency vs placebo, but the effects were weak. The authors concluded that short-term treatment is unlikely to be of major therapeutic benefit.

  • Chronic insomniacs; independent Uruguayan group replication

    25 nmol/kg4

    Route
    i.v.
    Frequency
    Once per night
    Duration
    4 nights
    n
    6 (FDA briefing: "six subjects with severe chronic insomnia")
    Design
    Double-blind crossover vs placebo, polysomnography
    Source quote
    DSIP in a dose of 25 nmol/kg or a placebo was administered i.v. during four nights using a double-blind crossover design.

    Finding. No significant differences vs baseline or placebo nights. The authors judged the sleep improvement to be of little clinical significance.

  • Chronic psychophysiological insomniacs, middle-aged (29-59) and older (60-83)

    30 nmol/kg b.w.5

    Route
    i.v.
    Frequency
    6 administrations over one week (abstract: "6 X 30 nmol/kg b.w."); FDA briefing describes it as each evening over five nights, so the schedule is inconsistent between sources
    Duration
    One week of treatment plus one-week follow-up
    n
    18 (abstract: "The population of 18 chronic psychophysiological insomniacs")
    Design
    Double-blind sleep laboratory study, no separate placebo arm reported in the FDA summary
    Source quote
    The immediate effects of one week of Delta Sleep-Inducing Peptide (DSIP) administration (6 X 30 nmol/kg b.w., i.v.) and late effects after a follow-up period of one week were investigated in a sleep laboratory study. The population of 18 chronic psychophysiological insomniacs was subdivided

    Finding. The authors report that sleep normalized. FDA notes that small samples, no adequate control group and external matched controls limit interpretation.

  • Severe chronic insomniacs, middle-aged; 7-night course with daytime performance testing

    30 nmol/kg6

    Route
    IV
    Frequency
    Nightly
    Duration
    7 successive nights (nights 3 through 9)
    n
    14 (FDA briefing: "in 14 middle-aged subjects with chronic insomnia")
    Design
    Double-blind; FDA reads it as externally matched controlled (no concurrent placebo arm)
    Source quote
    Subjects received seven successive emideltide IV injections 30 nmol/kg on nights 3 (treatment 1) through 9 (treatment 7).

    Finding. Sleep latency and wake after sleep onset improved vs the subjects' own baseline. FDA notes there was no concurrent placebo arm and the methodology was poor.

  • Chronic insomniacs; multi-series investigational studies (single evening dose, four consecutive evenings, six consecutive mornings); optimal infusion 4-8 min

    25 nmol/kg (21.3 µg/kg)6

    Route
    IV infusion over 4 minutes
    Frequency
    Single dose 1 h before bed (series III); four consecutive evenings (series IV); six consecutive mornings (series V)
    Duration
    1 to 6 days depending on series
    n
    Series III 6, series IV 4, series V 2 (FDA footnote: "six severe chronic insomniacs", "4 severe insomniacs", "2 sleep-disturbed neurotic inpatients")
    Design
    Double-blind, placebo-controlled investigational series
    Source quote
    when IV emideltide 25 nmol/kg (21.3 µg/kg) infusion was administered either over 4 minutes 1 hour prior to bedtime as a single dose (series III) or repeated on four consecutive evenings (series IV) or repeatedly administered on six consecutive mornings (series V).

    Finding. Sleep-promoting effects began in the second hour and lasted at least 6 h. Sleep improved with repeated evening doses.

  • Review of Schneider-Helmert's insomnia studies; morning vs twice-daily injections

    25 nmol/kg b.w.7

    Route
    Injection (route not stated in abstract)
    Frequency
    Single injections before sleep; repeated morning injections; two doses daily was less effective
    Duration
    Not stated in abstract (build-up with normalization after four administrations)
    n
    Not stated in abstract
    Design
    Summary of investigations, double-blind clinical trials
    Source quote
    Two different studies showed improvement of sleep following single injections of 25 nmol/kg b.w. before sleep. Repeated administrations indicated a buildup with normalization of sleep structure after four administrations.

    Finding. Repeated administration built up to normal sleep structure after four doses. Morning injections added daytime activity. One case responded to higher doses.

  • Narcolepsy, single-patient case report (35-year-old male)

    25 nmol/kg6

    Route
    IV
    Frequency
    Evening-dose week, then morning-dose week; injections per day not stated in the sources read
    Duration
    Two 1-week treatment periods after 1 week baseline
    n
    1 (abstract: "a 35-year-old male narcoleptic")
    Design
    Case report
    Source quote
    Three investigational periods included: a week of baseline (B) measurements, a week of evening dose (E) of IV emideltide 25 nmol/kg, and a week of morning dose (M) of IV emideltide 25 nmol/kg.

    Finding. Fewer sleep attacks and more daytime alertness, stronger with morning injections. A single subject cannot support efficacy.

  • Alcohol (n=28) and opiate (n=39) withdrawal inpatients, sole treatment

    25 nmol/kg8

    Route
    Intravenous
    Frequency
    Not stated in abstract
    Duration
    Not stated in abstract
    n
    67 (abstract: "67 patients presenting withdrawal symptoms (28 from ethyl alcohol, 39 from opiates)"); 49 evaluable
    Design
    Open-label, uncontrolled
    Source quote
    DSIP (25 nmol/kg) was injected intravenously as sole treatment to 67 patients presenting withdrawal symptoms (28 from ethyl alcohol, 39 from opiates).

    Finding. The authors reported benefit in 48 of 49 evaluable patients with no major side effects. The study was uncontrolled, so efficacy is unproven.

  • Inpatients in alcohol (n=47) or opiate (n=60) withdrawal, University Hospital of Psychiatry, Geneva

    25 nmol/kg (0.0214 mg/kg)6

    Route
    IV
    Frequency
    On request for recurring symptoms, or at fixed 6-8 hour intervals; up to 6 injections per day
    Duration
    Up to six days (fixed regimen: 3 consecutive days)
    n
    107 (abstract: "107 inpatients presenting with symptoms of alcohol (n = 47) or opiate (n = 60) withdrawal")
    Design
    Uncontrolled, open-label
    Source quote
    Emideltide IV 25 nmol/kg (0.0214 mg/kg) was administered for withdrawal symptoms with maximal daily number of 6 injections for up to six days.

    Finding. Most objective withdrawal signs improved. Anxiety and insomnia often relapsed 24-72 h after stopping. FDA found the design too weak to judge efficacy.

  • Acute opioid withdrawal (DSM-4 opioid dependence, SOWS 1 score above 25)

    35 nmol/kg6

    Route
    IV
    Frequency
    Day 1: four and up to six injections; days 2-4: four injections; days 5-7: two injections
    Duration
    7 days
    n
    7 (FDA briefing: "in seven subjects meeting the DSM-4 diagnosis of opioid dependence")
    Design
    Open-label clinical trial
    Source quote
    were administered emideltide IV 35 nmol/kg using a fixed schedule: on day 1, four and up to six injections; on days 2, 3, and 4, four injections; on days 5, 6, and 7, two injections.

    Finding. Withdrawal scores fell after the first injection, but only two subjects completed the schedule and symptoms recurred. The authors called efficacy an open question.

  • Diabetic retinopathy; Russian product deltalicin; non-sleep endpoint (visual evoked potentials); the only non-IV human dosing found

    0.0003 g (300 mcg) g/day9

    Route
    Intranasal
    Frequency
    Daily
    Duration
    2 months
    n
    15 diabetic retinopathy patients treated within a 45-patient diabetic cohort plus 15 healthy controls (abstract)
    Design
    Clinical trial (Russian-language, PubMed article type Clinical Trial)
    Source quote
    Treatment with deltalicin (daily dose of 0.0003 g of delta sleep-inducing peptide intranasally for two months) decreased the latent period and led to less pronounced depression of VEP amplitude in patients with diabetic retinopathy

    Finding. Treated retinopathy patients showed a shorter latent period and faster visual evoked potential recovery. The finding is specific to that product and does not transfer to SC use or to the compounded formulary vial.

What clinics and vendors publish

These ranges come from clinic and vendor publications, not studies.

Community-reported

Weak evidence. The only practice numbers come from a non-clinical dosing-information site. Its author (Garret Grant, 'Founder & Lead Researcher') holds a B.S. in Civil Engineering from UCLA and lists no clinical or pharmacy credentials. The page says 'This is not a dosing recommendation'. The page also states that DSIP is on FDA's 'Category 2' list. That conflicts with FDA's own page, which lists it as nominated but withdrawn with no category. No human data exist for the SC route, and FDA identified no clinical studies by that route. The human IV trials ran from 1981 to 1998, and the only other human data are limited intranasal work in a non-sleep indication. IV infusion rate mattered in the trials (FDA: 4-8 min optimal, ineffective over 1 min). Its relevance to SC kinetics is unknown.

StartCommunity-reported
100 mcg SC (lower end of the source's 100-200 mcg 'Lower research planning' row)
TitrationCommunity-reported
None described in any source read. Do not up-titrate on an assumption of dose-response: animal data show bell-shaped dose-response curves (PMID 6548967), and an independent human replication (Monti 1987) found no significant effect at 25 nmol/kg.
TypicalCommunity-reported
100-200 mcg SC, described by the source as the 'most common community range'
CeilingCommunity-reported
No ceiling established. The source lists 200-300 mcg SC as a 'Higher research planning' range with sparse tolerability data.
FrequencyCommunity-reported
Single evening dose
RouteCommunity-reported
Subcutaneous
TimingCommunity-reported
1-3 hours before intended sleep
CycleCommunity-reported
Source lists 5-7 nights (mirrors trial windows), 4 weeks, and 6-8 weeks. Only the 5-7 night course matches human trial windows (IV, 3-7 nights); the source itself says of the 6-8 week cycle 'long-term safety data is limited'. No SC data at any duration.
  • Community-reportedOther web source10
    100-200 mcg Route SubQ Notes Most common community range; described in research write-ups, not clinical trials.
  • Community-reportedOther web source10
    200-300 mcg Route SubQ Notes Used in some research write-ups; tolerability and side-effect data are sparse.
  • Community-reportedOther web source10
    Most research write-ups describe a single evening subcutaneous research-use dose 1-3 hours before intended sleep.

Safety

Serious warnings

  • No FDA-approved product exists, so there is no boxed warning or label warning. The safety statements here come from FDA's July 2026 briefing and from trial reports.6
  • FDA reports three subjects with serious adverse effects in Dick 1984. Two had hypotension at the start of the first injection. The third had repeated episodes of general discomfort with perspiration and nausea lasting 15 minutes. One of these three developed 'progressive hypotension' after a second injection; no further detail is available.6
  • FDA states that no clinical studies of the subcutaneous route were identified and that safety is insufficiently characterized for chronic intermittent use. FDA notes that SC administration is generally associated with higher immunogenicity than IV. It also flags peptide aggregation as able to amplify immunogenicity, and flags possible peptide-related impurities.6
  • Because DSIP stimulates endorphin release, FDA notes possible reinforcing or addictive properties. No nonclinical abuse-potential studies were identified.6

Contraindications

  • No formal contraindications are established. The FDA briefing has no data on pregnancy, lactation, children, or renal or hepatic impairment. Absence of data is not evidence of safety.6
  • Use caution with a personal or family history of substance use disorder. FDA notes that stimulating endorphin release could confer reinforcing properties that contribute to addiction.6
  • Use caution in patients prone to hypotension. Hypotension was the serious adverse effect in the IV studies.6
  • Not studied. Patients on opioid antagonists (for example naltrexone) may have a blunted effect. This is extrapolated from rat data in which naloxone blocked DSIP's sleep effect.6

Adverse effects

  • In 107 withdrawal patients (Dick 1984), nine had minor, transient perspiration, headaches, nausea and vertigo. Withdrawal itself may explain some of these.6
  • FDA reports that IV emideltide in chronic insomnia studies was well tolerated with no significant adverse events. A FAERS search through March 3, 2024 returned zero reports.6
  • Five of six healthy volunteers reported a 'feeling of pressure to sleep' immediately after infusion. Insomniacs showed a slight arousing effect in the first hour after injection.6
  • After opioid-withdrawal treatment, some patients relapsed into anxiety with marked insomnia 24-72 hours after stopping.6
  • Dick 1983 reported no major side effect in 67 withdrawal patients.8

Monitoring

  • Check blood pressure before and after the first dose. This is a clinical inference from the hypotension FDA reported with IV dosing.6
  • Five of six healthy volunteers reported pressure to sleep immediately after infusion. Counsel patients on driving and activity after dosing.6
  • Ask about rebound insomnia or anxiety for 24-72 h after stopping. This was seen after withdrawal treatment.6
  • Ask the pharmacy for a certificate of analysis and endotoxin and sterility data. FDA flagged aggregation and impurities as unaddressed for injectable DSIP.6

Interactions

  • Animal data only: the opioid antagonist naloxone prevented DSIP's sleep-prolonging effect in rats, which is consistent with opioid-system involvement. No human interaction studies were found.6
  • Animal data (rabbits 1 mg/kg SC, cats 100 mcg/kg SC) showed sleep effects with a bell-shaped dose-response in most experiments. Higher doses should not be assumed to add effect.11

Handling

Reconstitution

No labeled or pharmacopeial reconstitution instructions exist. FDA briefing solubility data: the free base dissolves in water at 0.5 mg/mL (FDA expects possible solubility problems at 1,000 mcg/mL), and the acetate dissolves at 10 mg/mL in phosphate buffered solution at pH 7.2. Confirm the salt form with the pharmacy before reconstituting.

Storage before mixing

Per the FDA briefing, which cites vendor information: the lyophilized free base is stored at -20 C and is stable for three years. It is stable for 2 years at 4 C and for about 3 weeks at room temperature. Follow the pharmacy's beyond-use dating.6

Evidence

Human sleep and withdrawal data are intravenous and date from 1981-1998, mostly from one Swiss group. The insomnia studies were small and double-blind (n 4-18) with mixed results. Independent replications (Bes 1992, Monti 1987) found weak or clinically insignificant effects. The opioid-withdrawal data are uncontrolled. The only non-IV human data are Russian intranasal Deltalicin work in diabetic retinopathy, which did not study sleep. FDA's July 2026 briefing found insufficient evidence of effectiveness and safety, and no data at all for subcutaneous use. No FDA-approved product exists.

Mechanism

DSIP was isolated from rabbit cerebral venous blood. FDA reports that its sleep-inducing effects are conserved across species and depend on the opioid system. It does not appear to bind opioid receptors directly, but it can stimulate calcium-dependent endorphin release. It crosses the blood-brain barrier in nonclinical studies. Its serum half-life is very short (minutes) because it is rapidly hydrolyzed.6

Availability

Amounts offered

  • 5 mg

Custom strengths on request.

References

According to PubMed

  1. 1Acute and delayed effects of DSIP (delta sleep-inducing peptide) on human sleep behavior.Int J Clin Pharmacol Ther Toxicol 1981;19(8):341-5, 1981
  2. 2The influence of synthetic DSIP (delta-sleep-inducing-peptide) on disturbed human sleep.Experientia 1981;37(9):913-7, 1981
  3. 3Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study.Neuropsychobiology 1992;26(4):193-7, 1992
  4. 4Study of delta sleep-inducing peptide efficacy in improving sleep on short-term administration to chronic insomniacs.Int J Clin Pharmacol Res 1987;7(2):105-10, 1987
  5. 5Efficacy of DSIP to normalize sleep in middle-aged and elderly chronic insomniacs.Eur Neurol 1986;25(6):448-53, 1986
  6. 6FDA Briefing Document: Pharmacy Compounding Advisory Committee Meeting July 23-24, 2026 - Evaluation of Emideltide-related bulk drug substances (emideltide free base and emideltide acetate)U.S. Food and Drug Administration, 2026
  7. 7DSIP in insomnia.Eur Neurol 1984;23(5):358-63, 1984
  8. 8Successful treatment of withdrawal symptoms with delta sleep-inducing peptide, a neuropeptide with potential agonistic activity on opiate receptors.Neuropsychobiology 1983;10(4):205-8, 1983
  9. 9Using deltalicin for the treatment of patients with diabetic retinopathy.Eksp Klin Farmakol 2014;77(12):22-5, 2014
  10. 10DSIP Quick Start (dosing protocol page)Peptide Dosing Protocols, 2026
  11. 11Some pharmacological effects of delta-sleep-inducing peptide (DSIP).Eur Neurol 1984;23(5):346-52, 1984
  12. 12Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (page content current as of 04/22/2026)U.S. Food and Drug Administration, 2026
  13. 13The PEPTIDE-L Wave Rolls On! PCAC Adds Two More Bulk Drug Substances for the 503A List (July 28, 2026)FDA Law Blog, 2026
  14. 14Effects of delta-sleep-inducing peptide on 24-hour sleep-wake behaviour in severe chronic insomnia.Eur Neurol 1987;27(2):120-9, 1987
  15. 15Effects of DSIP in man. Multifunctional psychophysiological properties besides induction of natural sleep.Neuropsychobiology 1983;9(4):197-206, 1983
  16. 16Effects of DSIP on narcolepsy.Eur Neurol 1984;23(5):353-7, 1984
  17. 17DSIP in the treatment of withdrawal syndromes from alcohol and opiates.Eur Neurol 1984;23(5):364-71, 1984
  18. 18Opioid detoxification with delta sleep-inducing peptide: results of an open clinical trial.J Clin Psychopharmacol 1998;18(3):257-8, 1998

Last reviewed 2026-10-14. 66 figures checked against their sources. How this works