Key findings
Adults who took TruCBN™ 50 mg softgels nightly for 28 days reported large improvements in sleep across every validated measure collected. Insomnia Severity Index (ISI) scores fell from 15.4 to 9.6, and the share of participants in the clinical insomnia range fell from 56% to 20%.
Insomnia severity improved by a clinically meaningful amount. 47% of participants improved by 6 or more ISI points, the minimal important difference, and 43% ended the study in the no-insomnia range (ISI 0–7).
Participants with clinical insomnia improved most. Of 180 participants who began with clinical insomnia (ISI 15 or higher; median age 55), 69% ended below the clinical threshold and 59% improved by 6 or more points.
Sleep disturbance returned to population norms. The average PROMIS Sleep Disturbance T-score fell from 58.4 to 49.4, the US population average, and 70% of participants reached the minimal clinically important difference.
Nightly sleep improved within the first week. Diary sleep quality rose from 5.2 to 5.9 out of 10 in the first week of use and continued to rise to 6.3 by week 4. Nights with a mid-sleep wakeup fell from 80% in the baseline week to 63% in week 4.
Participants recognized the change themselves. 72% rated their sleep as improved on the Patient Global Impression of Change, and those ratings tracked measured ISI change.
The product was well tolerated. The most common reported side effects were next-day grogginess, headache and worse sleep, each reported by about 6% of users. 4% of participants withdrew after starting the product.
Results are consistent with the 2024 randomized trial. The rate of PROMIS improvement observed here was in line with the TruCBN™ arms of the published double-blind, placebo-controlled trial.
About the study
This was a single-arm, open-label, decentralized real-world study of TruCBN™ softgels in adults seeking better sleep. Participants completed a one-week baseline period without the product, followed by 28 days of nightly use, with validated questionnaires and a daily sleep diary throughout.
The study ran on People Science’s Chloe platform. Participants enrolled online, received the product at home and completed every assessment on their phone or computer. Enrollment took place in two cohorts between February and September 2026.
Eligibility and consent. Participants were adult volunteers seeking better sleep who completed an online eligibility screening. All participants gave informed consent electronically before enrolling.
Study timeline and assessments
Baseline
Daily sleep diary; ISI, PROMIS Sleep Disturbance 8a and PSS-10 before starting the product
TruCBN™ 50 mg nightly
Daily sleep diary and side-effect reporting; ISI and PROMIS around day 13 and day 27
End of study
ISI, PROMIS, PSS-10, Patient Global Impression of Change and perceived effects
Measures
| Measure | What it assesses | Scoring | Meaningful change |
|---|---|---|---|
| Insomnia Severity Index (ISI) | Insomnia symptoms and their impact over the past 2 weeks; 7 items | 0–28; higher is worse. 0–7 none, 8–14 subthreshold, 15–21 moderate, 22–28 severe | Drop of 6 or more points |
| PROMIS Sleep Disturbance 8a | Sleep quality and disturbance over the past 7 days; 8 items | Raw 8–40, converted to T-scores (population mean 50, SD 10); higher is worse | Drop of half the baseline standard deviation |
| Perceived Stress Scale (PSS-10) | Perceived stress over the past month; 10 items | 0–40; higher is worse | Reported as mean change |
| Patient Global Impression of Change (PGI-C) | Participant’s own rating of change in sleep | 1 very much improved to 7 very much worse | Rating of 1–3 counted as improved |
| Daily sleep diary | Sleep quality, feeling rested, night wakings, mood | Single items each morning | Reported as mean change |
Who participated
514 adults enrolled and provided baseline data, and 417 completed the study and were analyzed. Participants were mostly middle-aged and female, and most began the study with clinically relevant sleep problems.
Participant flow
Each outcome was analyzed among completers with both a baseline and an end-of-study score, so n varies by measure (321 ISI, 336 PROMIS, 346 daily diary).
| Completers (n = 388 with demographics) | |||
|---|---|---|---|
| Age, mean (SD) | 52.1 (12.5) yrs; 22–84 | Latino or Hispanic | 8% |
| Age 60 or older | 30% | Black or African American | 7% |
| Female / male | 65% / 35% | Asian or Asian American | 5% |
| White | 75% | Other, mixed or not disclosed | 6% |
Sleep at baseline. 56% of ISI completers began in the clinical insomnia range (ISI 15 or higher): 45% moderate and 11% severe. On PROMIS, 69% had at least mild sleep disturbance (T-score 55 or higher), including 41% moderate or severe.
Adherence. Completers recorded a median of 28 product-use diary days, and the median platform compliance score was 100%; 74% of completers had compliance of 80% or higher.
Insomnia severity fell by 5.8 points
Insomnia severity fell from the moderate clinical range to the subthreshold range, with most of the improvement in place by the second week of use. Across all 321 completers with baseline and end-of-study scores, ISI fell from 15.4 to 9.6 (within-person effect size dz = 1.05; p < 0.001, Wilcoxon signed-rank test).
Clinical insomnia fell from over half of participants to one in five
Share of participants by ISI severity band (n = 321). The two navy bands are the clinical insomnia range.
Mean scores at each assessment
ISI total score (n = 276)
PROMIS SD 8a raw score (n = 287)
Participants with all three assessments. Lower is better on both scales.
Response and remission
| Outcome | All completers (n = 321) | Clinical baseline, ISI 15+ (n = 180) |
|---|---|---|
| Mean ISI change | −5.8 | −7.4 |
| Improved by 6+ points (minimal important difference) | 47% | 59% |
| Improved by 8+ points | — | 47% |
| Ended below the clinical threshold (ISI below 15) | — | 69% |
| Ended in the no-insomnia range (ISI 0–7) | 43% | 29% |
| Score worsened | 9% | — |
Participants with severe insomnia at baseline (ISI 22–28, n = 35) improved by 9.2 points on average, and 60% improved by 6 or more points. Among participants aged 65 and older with clinical insomnia (n = 29), 48% improved by 6 or more points.
Sleep disturbance returned to the population average
On the PROMIS Sleep Disturbance 8a, the average participant moved from mild sleep disturbance to the US population average, and 70% reached the minimal clinically important difference.
| PROMIS Sleep Disturbance 8a (n = 336) | Baseline | End of study | Change |
|---|---|---|---|
| Raw score (8–40) | 27.7 | 20.1 | −7.7 |
| T-score (population mean 50) | 58.4 | 49.4 | −9.0 |
The change corresponds to about 0.9 population standard deviations (within-person effect size dz = 1.06; p < 0.001).
Moderate or severe disturbance fell from 41% to 12%
Reached the minimal clinically important difference. Using the half-baseline-SD threshold (3.2 raw points), 70% of participants achieved a clinically meaningful improvement. Participants with moderate or severe sleep disturbance at baseline (T-score 60 or higher, n = 138) improved by 12.5 T-score points on average, and 58% of them ended in the none-to-slight range.
Sleep quality rose in the first week and kept climbing
Every morning, participants answered short questions about the previous night. Comparing each participant’s baseline-week average with their product-period average, every sleep and mood item improved.
Average self-rated sleep quality, 0–10 scale
Baseline week (no product, dashed) versus weeks 1–4 of TruCBN™ 50 mg nightly. The axis starts at 5 to show the change.
| Diary item (participant averages, n = 346) | Baseline week | Product use | Change |
|---|---|---|---|
| Sleep quality (0–10) | 5.13 | 6.03 | +0.89 |
| Feeling rested (1 very poorly to 5 very well) | 2.55 | 3.14 | +0.59 |
| Woke during the night (share of nights) | 79% | 67% | −12 pts |
| Night wakings (estimated per night) | 1.95 | 1.49 | −0.46 |
| Daily mood (1–10) | 6.33 | 7.02 | +0.69 |
| Daily quality of life (1–5) | 3.59 | 3.77 | +0.18 |
All changes in the table are statistically significant (p ≤ 0.01). The improvement appeared quickly: average nightly sleep quality rose from 5.2 in the baseline week to 5.9 in the first week of use, and it continued to rise through week 4.
Stress fell, and participants saw the change themselves
Perceived stress (PSS-10)
Perceived stress decreased moderately over the study. Scores fell from 18.1 to 15.3 (−2.8 points, n = 303; within-person effect size dz = 0.50; p < 0.001).
72% rated their sleep as improved
36% of participants rated themselves as much or very much improved. The stepwise link between participants’ ratings and their measured ISI change supports the consistency of the self-reported data.
Perceived effects. When asked what changes they noticed (about 305 respondents; more than one answer allowed), 54% reported improved sleep quality, 28% improved mood, 22% reduced stress, 16% better mental clarity and 12% more energy.
Consistent with the randomized trial, in everyday use
In this real-world study of 417 adults, 28 days of TruCBN™ 50 mg softgel use was associated with large, clinically meaningful improvements in insomnia severity and sleep disturbance, with consistent gains in nightly sleep quality, night wakings, feeling rested, mood and perceived stress.
The improvements were largest among participants who began with clinical insomnia, most of whom ended the study below the clinical threshold. Benefits appeared within the first week of use and continued through week 4. Participants’ own global ratings of change matched their measured outcomes, and few participants withdrew after starting the product.
The size and pace of improvement in this everyday-use setting were consistent with the TruCBN™ arms of the 2024 randomized, placebo-controlled trial, supporting the generalizability of those trial findings to real-world use in an older population.
Questions about the study
What did the TruCBN™ real-world sleep study find?
Adults who took TruCBN™ 50 mg softgels nightly for 28 days reported large improvements across every validated sleep measure collected. Insomnia Severity Index (ISI) scores fell from 15.4 to 9.6 (−5.8 points, n = 321), the share of participants in the clinical insomnia range fell from 56% to 20%, 70% reached the PROMIS minimal clinically important difference, and 72% rated their own sleep as improved.
How was the study designed?
It was a 28-day, single-arm, open-label, decentralized real-world study run on People Science’s Chloe platform. Participants completed a one-week baseline without the product, then took one TruCBN™ 50 mg softgel each evening for 28 days, completing validated questionnaires and a daily sleep diary throughout.
How many people took part, and who were they?
514 adults enrolled and provided baseline data, and 417 completed the study and were analyzed. Completers had a mean age of 52, 30% were 60 or older, and 65% were female. 56% began in the clinical insomnia range (ISI 15 or higher).
How quickly did sleep improve?
Average nightly sleep quality in the daily diary rose from 5.2 to 5.9 out of 10 in the first week of use and kept rising to 6.3 by week 4. Most of the ISI improvement was in place by the second week.
What dose and format of TruCBN™ was studied?
Each TruCBN™ softgel contains 50 mg of cannabinol (CBN) in a medium-chain triglyceride (MCT) oil carrier, with gelatin and glycerin. Participants took one softgel by mouth in the evening before bed.
Which participants improved the most?
Participants who began with clinical insomnia (ISI 15 or higher, n = 180) improved by 7.4 points on average; 69% ended below the clinical threshold and 59% improved by 6 or more points. Participants with severe insomnia at baseline (n = 35) improved by 9.2 points on average.
Was TruCBN™ well tolerated?
Yes. The most common reported side effects were next-day grogginess, headache and worse sleep, each reported by about 6% of users, and 4% of participants withdrew after starting the product.
How do these results compare with the 2024 randomized trial?
The rate of PROMIS improvement in this study was in line with the TruCBN™ arms of the published 2024 double-blind, placebo-controlled trial (Kolobaric et al., Pharmaceuticals), which used the same PROMIS Sleep Disturbance 8a outcome.
Who sponsored and ran the study?
The study was sponsored by FloraWorks (FloraScience, Inc.), the maker of TruCBN™, and conducted on People Science’s Chloe research platform. Enrollment took place in two cohorts between February and September 2026.
References
- Kolobaric A, Saleska J, Hewlings SJ, Bryant C, Colwell CS, D’Adamo CR, et al. A randomized, double-blind, placebo-controlled trial to assess the effectiveness and safety of melatonin and three formulations of Floraworks proprietary TruCBN™ for improving sleep. Pharmaceuticals (Basel). 2024;17(8):977. doi:10.3390/ph17080977
- Yang M, Morin CM, Schaefer K, Wallenstein GV. Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009;25(10):2487–2494.
- Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011;34(5):601–608.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Anyone who is pregnant, nursing or taking medication should consult a physician before use.