People with epilepsy may experience episodes of frequent seizure activity (seizure clusters, acute repetitive seizures), and benzodiazepines are the cornerstone of rescue treatment. Cannabidiol (CBD) can be used as an adjunctive treatment for epilepsy, and it may interact with other antiseizure drugs, such as benzodiazepines. Here, we examined the safety and effectiveness of intermittent use of diazepam nasal spray in patients with seizure clusters who also received CBD treatment. This analysis included data from patients aged 6 to 65 years enrolled in a phase 3, long-term safety study of diazepam nasal spray. Age- and weight-based dosing of diazepam nasal spray were administered during a 12-month treatment period. Concomitant CBD use was recorded, and treatment-emergent adverse events (TEAEs) were collected. Of 163 treated patients, 119 (73.0%) did not receive CBD, 23 (14.1%) received the US Food and Drug Administration–approved highly purified CBD and 21 (12.9%) received another form of CBD. On average, patients receiving highly purified CBD were younger and more likely to have epileptic encephalopathies, including Dravet syndrome or Lennox-Gastaut syndrome, than patients who received another CBD preparation or no CBD. Rates of TEAEs and serious TEAEs were greater in patients who received any form of CBD (90.9% and 45.5%, respectively) compared with no CBD (79.0% and 26.1%, respectively). However, the lowest rates of TEAEs attributed to diazepam nasal spray were reported in patients who received highly purified CBD (13.0%), and this result was maintained in those who received concomitant clobazam. Use of second doses of diazepam nasal spray, a proxy for effectiveness, was lowest in the highly purified-CBD group (8.2%) compared with the no-CBD (11.6%) and other-CBD groups (20.3%). These results suggest that CBD does not alter the safety and effectiveness of diazepam nasal spray and supports concomitant use in appropriate patients.

癫痫患者可能会经历频繁的癫痫发作（丛集性癫痫发作、急性重复性癫痫发作），而苯二氮卓类药物是抢救治疗的基石。大麻二酚 (CBD) 可用作癫痫的辅助治疗，并且可能与其他抗癫痫药物（例如苯二氮卓类药物）相互作用。在这里，我们检查了接受 CBD 治疗的癫痫发作丛集性患者间歇使用地西泮鼻喷雾剂的安全性和有效性。该分析包括参加地西泮鼻喷雾剂长期安全性第 3 期研究的 6 至 65 岁患者的数据。在 12 个月的治疗期间，根据年龄和体重给予地西泮鼻喷雾剂剂量。记录伴随的 CBD 使用情况，并收集治疗中出现的不良事件 (TEAE)。在 163 名接受治疗的患者中，有 119 名（73. 0%）没有接受 CBD，23 人（14.1%）接受了美国食品和药物管理局批准的高纯度 CBD，21 人（12.9%）接受了另一种形式的 CBD。平均而言，与接受另一种 CBD 制剂或不接受 CBD 的患者相比，接受高度纯化 CBD 的患者更年轻，更有可能患有癫痫性脑病，包括 Dravet 综合征或 Lennox-Gastaut 综合征。接受任何形式 CBD 的患者的 TEAE 和严重 TEAE 发生率（分别为 90.9% 和 45.5%）高于未接受 CBD 的患者（分别为 79.0% 和 26.1%）。然而，在接受高纯度 CBD 的患者中，由地西泮鼻喷雾剂引起的 TEAE 发生率最低 (13.0%)，并且在同时接受氯巴占的患者中也维持了这一结果。使用第二剂地西泮鼻喷雾剂（有效性的代表）与无 CBD (11.6%) 和其他 CBD 组 (20.3%) 相比，高度纯化的 CBD 组 (8.2%) 最低。这些结果表明 CBD 不会改变地西泮鼻喷雾剂的安全性和有效性，并支持在适当的患者中同时使用。