Our Landmark Clinical Trial
Tested in a rigorous human study, validated by peer-review. Physicians and consumers can trust Defined Sleep is backed by the strongest science available.
Key Highlights
FDA-registered
Phase II Clinical Trial
Increased Deep & REM Sleep
An Alternative to Traditional Pharma
Proprietary Formula
Contains No THC
Defined Sleep contains no THC and does not cause intoxication, unlike most CBD products. It's a safe option for those required to undergo workplace drug testing or anyone who may have aversions to the stigma of THC. Will not cause fall risk for elderly.
No Adverse Effects
Shift Worker Efficacy
Individuals who sleep during the day (e.g. shift-workers) and had severe insomnia were highly responsive to treatment with Defined Sleep according to trial data.
Clinical Trial Methodology
Trial participants consisted of ~125 insomnia-suffering adults selected from across the United States. Objective sleep data was collected via wearable sleep-tracking technology. Subjective feedback was obtained via participant surveys. Importantly, the clinical trial was approved by an Institutional Review Board (IRB), which ensured the human study was governed in accordance with FDA regulations. A medical monitor carefully tracked any adverse events that could have occurred in the clinical trial, and found none.
The publication that reports the data from our clinical trial is available upon request by emailing us at support@definedsleep.com.
125 Participants
Study participants were insomnia-suffering adults from across the U.S.
Comprehensive Data
IRB Approved
Our study was approved by an Institutional Review Board, in accordance with FDA regulations.
Product Purity
At Defined Sleep, we’re committed to delivering the highest level of formula purity in all of our ingredients. We’ve spent years carefully selecting and testing everything that goes into our product, and we lab-test every batch before it’s bottled. The result is that every batch of Defined Sleep contains the same, precise concentrations of active ingredients – consistently resulting in a better night’s sleep.
This rigorous approach is different than most CBD sleep products which are composed of extracts from hemp plants. The problem for consumers is that the specific contents of every extract can vary dramactically from crop to crop – just like wines from the same vineyard taste different each year.
Product Testing
Every lot of Defined Sleep is tested to ensure the highest quality and safety standards. We use CBD isolate that is 99.9% pure and has 0.0% THC (not a plant extract). Our CBD isolate is procured from a GMP certified manufacturer using Colorado grown hemp. Our third party testing is performed by an ISO/IEC 17025:2005 accredited laboratory that is recognized by the United States Food and Drug Administration (FDA). All of our products are tested for Potency, Terpenes, Pesticides, Heavy Metals, Residual Solvents, Foreign Materials and Bacteria. These tests ensure that each lot of Defined Sleep is exactly the same and is free of contaminants.