Dsip: Safety Profile & Research Summary
Expert ReviewedGMP CertifiedLast Reviewed: February 2026
Preclinical Research Summary
Key Preclinical Studies
| Study | Model | Key Findings | Ref |
|---|---|---|---|
| Mu et al. (2024) | Mice — PCPA-induced insomnia | Wakefulness ↓ from 720→600 min (p<0.001); ↑ serotonin + melatonin | [1] |
| Monnier/Polc (1977–78) | Rabbits/Cats — EEG/sleep | 39–54% increase in delta activity (rabbits); enhanced REM in cats | [17] |
| Tukhovskaya et al. (2021) | SD rats — MCAO stroke, 120 µg/kg intranasal | Significant motor recovery (Rotarod p<0.01); infarct size not significantly reduced | [7] |
| Tukhovskaya et al. (2021) | SD rats — MI reperfusion, 150 µg/kg IP | IA/AAR reduced to 28.7% vs 42.1% control (p=0.01); ⚠️ 100% mortality during occlusion | [8] |
| Popovich et al. (2003) | SHR mice — 2.5 µg/mouse SC monthly | Max lifespan +24.1% (917 vs 739 d); tumors ↓2.6-fold; chromosomal aberrations ↓22.6% | [10] |
| Hrnčić et al. (2018) | Rats — lindane-induced seizures, 1 mg/kg IP | Reduced seizure intensity; prolonged seizure latency; decreased EEG ictal periods | [16] |
| Scherschlicht/Tissot (Patent) | Mice — morphine withdrawal (naloxone-precipitated) | Dose-dependent withdrawal inhibition: 0.3 mg/kg SC reduced jumping to 54% of control | [13] |
| Nakamura et al. (1988) | Mice/Rats — pain tests (tail-pinch, hot plate) | Potent dose-dependent antinociception via ICV; blocked by naloxone (opioid-mediated) | [11] |
Clinical / Human Studies
| Trial | Population | Key Results | Outcome | Ref |
|---|---|---|---|---|
| Acute Effects in Normals | n=6 healthy adults | 59% median increase in total sleep time; ↑ SWS and REM | Success | [3] |
| 7-Night Insomnia Treatment | n=14 chronic insomniacs | Normalized sleep efficiency and daytime alertness to levels of healthy controls | Success | [4] |
| Withdrawal Syndromes | n=107 (47 alcoholics, 60 opiate addicts) | Opiate: 97% improved; Alcohol: 87% improved; DTs terminated in 6/8 | Success | [2] |
| Chronic Pain Pilot | n=7 (migraine, tinnitus, psychogenic pain) | Pain reduced in 6/7 patients; simultaneous reduction in depression | Success | [5] |
| Double-Blind Insomnia | n=16 chronic insomniacs | Effects described as "weak"; authors concluded "not likely to be of major therapeutic benefit" | Failure | [3] |
Safety Summary
| Parameter | Finding |
|---|---|
| FDA Category 2 Warning | "Significant safety risks" — potential immunogenicity; "lacks sufficient information"; not approved for compounding |
| Acute Toxicity (Animals) | Oral LD50 in rats >5,000 mg/kg; MTD in dogs >2,000 mg/kg — high safety margin |
| Historical Human Trials | Mild adverse events: headache, nausea, vertigo; described as "incredibly safe" in 70+ subjects |
| ⚠️ CRITICAL TIMING | 100% mortality when given during active ischemic occlusion (MI or stroke); protective ONLY during reperfusion |
| Pharmacokinetics | Half-life ~15 min; degraded by aminopeptidases (N-terminal Trp cleavage); crosses BBB partly |
| Drug Interactions | Antagonizes morphine; reversed by naloxone; reverses amphetamine hyperthermia; incompatible with peptidase inhibitors (captopril) |
Related Research Questions
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