DetailsFor supplement and nutraceutical brands
BENESOMNO™ — Clinically Validated Sleep Ingredient
Clinically Validated Sleep Ingredient
- 2 Randomized Controlled Trials
- Validated by Polysomnography
- Lime Peel Extract
- 300 mg/day
- GABA Agonist
Ingredient Profile
A Clinically ValidatedSleep IngredientDerived from Lime peel
BENESOMNO™ is a standardized lime (Citrus aurantiifolia) peel extract developed to support healthy sleep, with its quality, safety, and efficacy supported by analytical, preclinical, and human clinical evidence.
Key Highlights
Clinically Validated
- 2 RCTs, polysomnography
- Single-dose & 2-week trials
Naturally Derived
- Key lime peel extract
- Citrus aurantiifolia
- Non-GMO
Regulatory Status
- HFF (2025-26), KOREA
- NDI (1416), USA
Safety Evaluated
- No adverse effects
- NOAEL > 2,000 mg/kg
Mechanism
- GABAA receptor activation
- GABA-binding site agonist
Dosage and Timing
- 300 mg/day
- 30-60 min before or at bedtime
Dosage Forms
- Applicable to all forms
- Gummy, liquid, etc.
Marker Compound
- Vicenin-2
(Lime-specific flavonoid)Certification
- GMP
- FSSC 22000
- Halal
BENESURE
- Efficacy validation program
- Lot to final products
Stability
- Highly stable against heat, pH, and UV exposure
Patents
- Granted in Korea
- Filed in USA, EU, China
Efficacy
Clinically Validated Sleep-Support Efficacy
2-Week Daily-Intake Human Clinical Trial (Completed)
- Study design: A 2-week, randomized, double-blind, placebo-controlled clinical trial in 80 adults aged 19–64 years
- Dose and duration: One 300 mg capsule of BENESOMNO™ once daily, 30 min before bedtime, for 2 weeks
- Efficacy endpoints : Polysomnography-based sleep parameters
Sleep latency
64.1%
16 min
Total wake time
41.7%
33 min
Wake after sleep onset
31.5%
17 min
Total sleep time
10.7%
33 min
Sleep efficiency
8.5%
Stage 2 sleep
8.7%
21 min
Clinical Study 2
In preparationof a research article
Acute Human Clinical Trial (Completed)
- Study design: A randomized, double-blind, placebo-controlled crossover human clinical trial in 25 adults with sleep disturbance
- Period and dosage: A single 300 mg dose of BENESOMNO™, administered 30 min before bedtime, with a 1-week washout between treatment periods
- Efficacy endpoints: Polysomnography-based sleep parameters and subjective sleep outcomes assessed using the LSEQ and VAS
Clinical Study 3
Planned
8-Week Human Clinical Trial (Planned)
- Objective: To evaluate the effects of continued BENESOMNO™ use on sleep and stress-related tension
- Study design: An 8-week, randomized, double-blind, placebo-controlled clinical trial in 100 adults aged 19–65 years with normal sleep patterns and moderate stress (50 BENESOMNO, 50 placebo)
- Dose and duration: BENESOMNO™ 200 or 300 mg once daily for 8 weeks
- Key sleep endpoints: Actigraphy-derived sleep parameters
- Key stress endpoints: Questionnaire-based outcomes (SRI, PSS, VAS, K-BAI, and K-BDI) and biomarkers (serotonin and cortisol)
EEG Study of BENESOMNO™
- Test substance: BENESOMNO™ (SLPS; standardized lime peel supplement)
- Animal model: C57BL/6N mice
- Key findings: Oral administration of BENESOMNO™ (100–400 mg/kg) dose-dependently increased NREM sleep. Significant reductions in sleep latency were observed at 200 and 400 mg/kg. At 400 mg/kg, sleep latency, NREMS duration, and wake time did not differ significantly from those observed with zolpidem (10 mg/kg).
- Sleep latency
- NREMS Duration
- Wake Time
(Non-rapid eye movement sleep)
Preclinical Study 2
In preparationof a research article
Long-term EEG Study of BENESOMNO™
- Test substance: BENESOMNO™ (SLPS; standardized lime peel supplement)
- Animal model: C57BL/6N mice
- Key findings: Oral administration of BENESOMNO™ (100–400 mg/kg) dose-dependently increased NREM sleep. Significant reductions in sleep latency were observed at 200 and 400 mg/kg. At 400 mg/kg, sleep latency, NREM sleep duration, and wake time did not differ significantly from those observed with zolpidem (10 mg/kg).
Preclinical Study 3
In preparationof a research article
BENESOMNO™ + Caffeine EEG Study
- Test substance: SLPS (standardized lime peel supplement) = BENESOMNO™
- Test animal: C57BL/6N mice
- Results: SLPS (300 mg/kg) normalized caffeine-induced NREMS reduction to vehicle levels. It also maintained natural sleep quality by preserving NREMS delta activity.
Mechanism
GABAergic Mechanism for Sleep Support
The GABAA receptor is a key receptor that calms neuronal activity, acting as a “sleep switch” that helps initiate and maintain sleep. BENESOMNO™ binds to the GABA-binding site of the GABAA receptor and directly activates the receptor, helping individuals fall asleep faster and maintain stable sleep. The mechanism of action of BENESOMNO™ has been scientifically demonstrated through preclinical studies.
Evidence 1: Receptor Binding
BENESOMNO™ demonstrated binding affinity for the GABA-binding site of GABAA receptors in a competitive binding assay using [³H]muscimol, a radiolabeled ligand for this site.
Evidence 2: In Vitro Functional Activation
BENESOMNO™ directly and concentration-dependently activated GABAA receptors in vitro, supporting agonist activity at the GABA-binding site.
Evidence 3: In Vivo Validation
In mice, the GABAA receptor antagonist bicuculline blocked the sleep-promoting effects of BENESOMNO™, supporting GABAA receptor-mediated action in vivo.
Safety
Safety Evaluatedfor Daily Use
Key lime peel has long been used as a culinary ingredient, including as zest and in preserves such as marmalade. BENESOMNO™, a standardized key lime peel extract, has also been evaluated in a human clinical trial and a comprehensive battery of toxicity studies. No serious adverse events were reported in the clinical trial, and no test substance-related adverse effects were observed under the conditions of the toxicity studies.
Clinical Safety
More- Test product: BENESOMNO™ (SLPS; standardized lime peel supplement)
- Study design: A 2-week, randomized, double-blind, placebo-controlled clinical trial in 80 adults aged 19–64 years
- Dose and duration: BENESOMNO™ 300 mg once daily (one capsule) for 2 weeks
- Results: No serious adverse events were reported, and no clinically significant changes were observed in vital signs, clinical assessments, hematology, or clinical chemistry parameters.
Toxicological Safety
More- Acute oral toxicity: LD₅₀ > 2,000 mg/kg bw
- 90-day repeated-dose toxicity: NOAEL ≥ 2,000 mg/kg bw/day (highest dose tested)
- Genotoxicity: Negative in bacterial reverse mutation, in vitro chromosomal aberration, and in vivo micronucleus tests
No test substance-related adverse effects were observed in GLP-compliant toxicity studies conducted according to OECD Test Guidelines
Regulatory
Regulatory Recognition Across Key Markets
BENESOMNO™ has achieved regulatory recognition in Korea as an individually recognized Health Functional Food ingredient and has been notified to the U.S. FDA as a New Dietary Ingredient (NDI). We continue to advance regulatory activities in other key markets to support broader global market access.
Health Functional Food Ingredient(MFDS, Korea)
| Ingredient Name | Lime Peel Extract |
|---|---|
| Approval No. | 2025-26 (05/12/2025) |
| Health Claim | May help to improve sleep quality |
| Daily Dose | 300 mg |
New Dietary Ingredient Notification(FDA, USA)
Details| Ingredient Name | BENESOMNO™ (Lime Peel Extract) |
|---|---|
| Notification No. | 1416 (09/09/2025) |
| Daily Dose | 300 mg |
Quality
From Raw Material to Finished Ingredient
BENESOMNO™ is manufactured in a specialized nutraceutical ingredient facility certified to FSSC 22000 standards and holding GMP and Halal certifications, supporting consistent quality and food safety.
Specialized Natural-Product Extraction Facility
Advanced Extraction and Processing Equipment
Quality Management System
Nutra-it maintains consistent quality and traceability across the entire supply chain through qualified raw material sourcing, certified manufacturing, and controlled distribution.
Raw Material Supplier
- Food-grade key lime peel
- Non-GMO and vegan
- Halal-certified
- Traceable sourcing
Contract Manufacturer
- FSSC 22000
- GMP, Halal
- Specialized in natural-product extraction
Distribution Partners
- Authorized distribution partners
- Controlled storage and handling
Pre-import QualityEvaluation
Manufacturing Control &Process Monitoring
Feedback
Quality Management System
Imported Only AfterMeeting Quality Specifications
Accepted Only AfterMeeting Quality Specifications
BENESURE (Efficacy Validation Program)
Technical Support
BENESURE (Efficacy Validation Program)
BENESURE : Efficacy Validation Program
BENESURE
BENESURE validates BENESOMNO’s efficacy from ingredient lot to finished formulation.
BENESURE is Nutra-it’s proprietary efficacy validation program designed to verify the batch-to-batch consistency of BENESOMNO™’s sleep-support activity and evaluate whether that activity is preserved in finished-product formulations.
For every production lot, Nutra-it validates the sleep-promoting effect of BENESOMNO™ to confirm that it meets our internal efficacy standards. This lot-level validation allows us to supply BENESOMNO™ with confidence and consistency.
Beyond the ingredient itself, we also recognize that the performance of BENESOMNO™ can be influenced by finished-product formulations. Additional ingredients may attenuate, maintain, or enhance BENESOMNO™’s sleep-promoting effect. Since many corporate partners develop their own proprietary formulations, it is important to evaluate whether those formulations preserve or improve the intended activity of BENESOMNO™.
As part of BENESURE, Nutra-it offers complimentary efficacy validation for final-formulation samples submitted by BENESOMNO™ partners. Formulation ratios do not need to be disclosed. Partners only need to provide the finished formulation sample, and Nutra-it will report the validation results within one month.
Through this dual efficacy validation system, Nutra-it aims to help ensure that BENESOMNO™’s sleep-promoting effects are consistently delivered from the ingredient lot to the final consumer product.
BENESURE: Efficacy Validation Program
Example
Lot Number: NL-251205-03
Nutra-it operates BENESURE, a proprietary efficacy validation program for BENESOMNO™. While most ingredient suppliers focus primarily on basic specifications such as chemical composition, marker content, and microbiological safety, Nutra-it goes one step further by validating the sleep-promoting activity of BENESOMNO™ itself—the most critical performance attribute of a functional ingredient. BENESURE™ reflects Nutra-it’s commitment to science-based quality control, lot-to-lot consistency, and reproducible functional performance.
- Ingredient / Lot number: BENESOMNO™ / NL-251205-03
- Test method: Pentobarbital-induced sleep test (Source: Kim et al., Biomedicine & Pharmacotherapy 179, 117410, 2024)
- Positive control: Doxepin hydrochloride (USP Reference Standard), 25 mg/kg
BENESURE: Efficacy Validation Program
ExampleContaining BENESOMNO™ (NL-251204-02)
Nutra-it operates BENESURE, a proprietary efficacy validation program for BENESOMNO™. Through this program, we offer complimentary efficacy validation for finished supplement formulations containing BENESOMNO™. This service evaluates whether co-ingredients preserve, enhance, or attenuate BENESOMNO™’s sleep-promoting effects. By identifying potential synergistic or inhibitory effects in advance, BENESURE helps partners scientifically assess the functional performance of their final product formulations before launch.
- Product / Company: Blind
- Test method: Pentobarbital-induced sleep test (Source: Kim et al., Biomedicine & Pharmacotherapy 179, 117410, 2024)
- Positive control: BENESOMNO™ (NL-251204-02), 300 mg/kg
Products
Finished Products Featuring BENESOMNO™
Explore supplement products formulated with BENESOMNO™, developed and marketed by our brand partners.
USA
DetailsComing Soon(2026)
Coming Soon(2026)
News
Latest from BENESOMNO™
Discover BENESOMNO™ research, media coverage, product applications, and global partnership updates from Nutra-it.
Read More News
Grobal Partner Network
Expanding through global partnerships
BENESOMNO™ is expanding its global presence through partnerships in key markets, including the United States, Korea, Italy, Taiwan, Australia, and New Zealand. Select a partner logo to visit the partner’s website.
