Our Landmark Clinical Trial

Defined Sleep is the only CBD-based sleep aid clinically proven to increase restorative sleep.

Tested in a rigorous human study, validated by peer-review. Physicians and consumers can trust Defined Sleep is backed by the strongest science available.

Effects of a cannabidiol/terpene formulation on sleep in individuals with insomnia: a double-blind, placebo-controlled, randomized, crossover study

Key Highlights

FDA-registered
Phase II Clinical Trial

Clinical trial results showed participants with severe insomnia experienced increased deep and REM sleep and decreased light sleep after taking Defined Sleep. Objective data was captured and reported by Whoop, a wrist-worn sleep-tracking device. Subjectively, the majority of study participants reported an improvement in their sleep quality and duration.

Increased Deep & REM Sleep

Defined Sleep increased deep and REM sleep (restorative sleep) up to 1-hour per night during a 1-month period in individuals with insomnia. This has major health implications because restorative sleep supports the immune system, learning, memory, attention, cognition, and cell and tissue regeneration.

An Alternative to Traditional Pharma

While Defined Sleep increases restorative sleep, it has no sedative properties. It's a promising alternative to many prescription sleep medications and over-the-counter (OTC) sleep aids that cause sedation, but deprive users of restorative sleep.

Proprietary Formula

Defined Sleep's patent-pending formula combines a class-leading 300 mg of CBD per dose with eight plant-based terpene molecules thought to amplify CBD's inherent sleep-promoting benefits. Our dose of CBD is significantly higher than most competing products, ensuring consistent efficacy, and it's safe to take every night.

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

No adverse effects of Defined Sleep were observed in our clinical trial despite careful tracking by a medical monitor. Thee results indicate Defined Sleep lacks the harmful side effects found in many OTC sleep aids and prescription sleep medicines.

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

Objective data was captured with a wearable sleep-tracking device called Whoop. Subjective data was collected via participant surveys.

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.