Cannabidiol for Sedative/Hypnotic-sparing Management of Insomnia in Adults

INVESTIGATORS: Mariana Cherner, PhD

STUDY LOCATION: University of California, San Diego

PROJECT TITLE: Cannabidiol for Sedative/Hypnotic-sparing Management of Insomnia in Adults

FUNDING SOURCE: Center for Medicinal Cannabis Research

PROJECT TYPE: Clinical Study

STATUS: Enrollment Pending

ABSTRACT:

It is estimated that up to a third US adults suffer from sleep problems, which are in turn associated with sub-optimal, and sometimes compromised, daily functioning.  Sedative and hypnotic medications constitute the main pharmacologic treatment for insomnia, but they are habit-forming and associated with adverse next-day “hangover” effects, including impaired driving and risk of falls. Sedative/hypnotics are also increasingly being linked to longer-term neurocognitive deficits.  Therefore, a substitute medication with low abuse potential and a benign cognitive profile would be highly desirable. As the endocannabinoid system is involved in regulation of circadian rhythm, exogenous cannabinoids may have therapeutic potential in the area of sleep. A few studies not specifically targeting insomnia indicate that CBD use may result in sedation. However, objective scientific evidence is lacking with regard benefits, detrimental effects, or effective dose. We propose a randomized, double-blind placebo-controlled phase II study to examine the noninferiority and efficacious dose range of CBD in managing symptoms of insomnia compared to sedative/hypnotic medication. We will measure sleep outcomes objectively using wrist-worn actigraphy as well as by self-report via real-time ecological momentary assessment and traditional questionnaires. We will also compare objective next-morning neuropsychological performance. Positive study results will provide support for the use of CBD as a potential sedative/hypnotic-sparing treatment for insomnia.