40% of Epidiolex prescriptions in the US were for off-label conditions, with common drug interactions
Among 4,214 Americans prescribed Epidiolex (pharmaceutical CBD) in 2022, 40% did not have FDA-approved diagnoses in their medical record, and nearly half were co-prescribed benzodiazepines known to interact with CBD.
Quick Facts
What This Study Found
Of 4,214 Epidiolex recipients, 40% lacked FDA-approved diagnostic indications (Lennox-Gastaut, Dravet, or tuberous sclerosis) in their records. Off-label use was primarily for other epilepsy syndromes (53.8%), sleep disorders (25.7%), anxiety (25.9%), mood disorders (18.6%), and autism (10.8%). Co-prescribing of interacting benzodiazepines was prevalent: clobazam 47.2%, diazepam 47.4%, clonazepam 40.7%.
Key Numbers
4,214 Epidiolex recipients in 2022; 40% off-label; co-prescribed clobazam 47.2%, diazepam 47.4%, clonazepam 40.7%; off-label uses: epilepsy 53.8%, sleep 25.7%, anxiety 25.9%, mood 18.6%, autism 10.8%
How They Did This
Analysis of the TriNetX database of de-identified electronic health records from over 110 million US patients, examining 4,214 individuals prescribed Epidiolex in 2022 for diagnostic indications and co-occurring prescriptions.
Why This Research Matters
Widespread off-label CBD prescribing and concurrent use of interacting medications create potential safety concerns that may not be well-studied or monitored.
The Bigger Picture
The substantial off-label use of prescription CBD for conditions like anxiety, sleep, and autism reflects a gap between patient/provider interest in CBD and the available evidence base for these conditions.
What This Study Doesn't Tell Us
EHR data may have incomplete diagnostic coding; off-label use may be clinically appropriate even if evidence is limited; cannot determine if interactions resulted in adverse events; co-prescribing does not mean simultaneous use; 2022 single-year snapshot
Questions This Raises
- ?Are prescribers monitoring for CBD-benzodiazepine interactions?
- ?Should off-label Epidiolex prescribing trigger additional safety monitoring?
- ?What outcomes are patients experiencing with off-label use?
Trust & Context
- Key Stat:
- 40% off-label; 47% co-prescribed interacting benzodiazepines
- Evidence Grade:
- Large real-world database analysis capturing prescribing patterns, but limited by EHR coding accuracy and inability to assess clinical outcomes.
- Study Age:
- 2024 publication analyzing 2022 prescribing data
- Original Title:
- Cannabidiol prescribing in the United States: An analysis of real-world data.
- Published In:
- Drug and alcohol dependence reports, 13, 100303 (2024)
- Authors:
- Lin, Binx Yezhe, Lessard, Chloe, Li, Yifan(2), Gong, Lisa, Ling, Ruth, Jyotsana, Pallawi, Steinle, Jacob, Borodovsky, Jacob T, Nascimento, Fábio A, Xu, Kevin Y
- Database ID:
- RTHC-05477
Evidence Hierarchy
Watches what happens naturally without intervening.
What do these levels mean? →Frequently Asked Questions
What is Epidiolex prescribed for beyond its FDA approval?
The most common off-label uses were other epilepsy syndromes (53.8%), sleep disorders (25.7%), anxiety disorders (25.9%), mood disorders (18.6%), and autism spectrum disorders (10.8%). Epidiolex is only FDA-approved for Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.
Why is the drug interaction concern important?
Nearly half of Epidiolex recipients were also prescribed benzodiazepines (clobazam, diazepam, clonazepam) that are known to interact with CBD. CBD can increase blood levels of these drugs, potentially intensifying their sedative effects and side effects.
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Cite This Study
https://rethinkthc.com/research/RTHC-05477APA
Lin, Binx Yezhe; Lessard, Chloe; Li, Yifan; Gong, Lisa; Ling, Ruth; Jyotsana, Pallawi; Steinle, Jacob; Borodovsky, Jacob T; Nascimento, Fábio A; Xu, Kevin Y. (2024). Cannabidiol prescribing in the United States: An analysis of real-world data.. Drug and alcohol dependence reports, 13, 100303. https://doi.org/10.1016/j.dadr.2024.100303
MLA
Lin, Binx Yezhe, et al. "Cannabidiol prescribing in the United States: An analysis of real-world data.." Drug and alcohol dependence reports, 2024. https://doi.org/10.1016/j.dadr.2024.100303
RethinkTHC
RethinkTHC Research Database. "Cannabidiol prescribing in the United States: An analysis of..." RTHC-05477. Retrieved from https://rethinkthc.com/research/lin-2024-cannabidiol-prescribing-in-the
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.