Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia

Summary

Insomnia is a disorder in which people have inadequate or poor-quality sleep due to a number of factors, such as difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up too early in the morning, or having unrefreshing sleep. Defined CBD is a capsule composed of highly purified (\>99.9%) hemp-derived cannabidiol (CBD) and terpenes produced as a potential sleep aid for people with insomnia. This product contains no detectable Delta-9-tetrahydrocannabinol (Delta-9-THC). This trial is specifically designed to evaluate the efficacy of Defined CBD on sleep physiology in people with insomnia.

Timeline

Start

2022-02-18

Primary completion

2022-07-02

Completion

2022-07-02

Outcome

Met primary endpoint

registry analysis (superiority test); Defined CBD vs Placebo; p = 0.0350; Mean Difference (Final Values) 1.3 (95% CI 0.1 to 2.5); t-test, 2 sided NCT05233761 ↗

Publications

• Wang M, Faust M, Abbott S, Patel V, Chang E, Clark JI, Stella N, Muchowski PJ. Effects of a cannabidiol/terpene formulation on sleep in individuals with insomnia: a double-blind, placebo-controlled, randomized, crossover study. J Clin Sleep Med. 2025 Jan 1;21(1):69-80. doi: 10.5664/jcsm.11324.

Drugs

Indications