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The present study examined clinical variables related to excessive daytime sleepiness (EDS) and sleep disorders in patients with epilepsy (PWE), with special focus on antiepileptic drugs (AEDs), to determine whether sleep-related problems in PWE are correlated with their involvement in traffic accidents. Method: 325 PWE completed the Epworth Sleepiness Scale (ESS) and 322 the Pittsburgh Sleep Quality Index (PSQI). 239 PWE with a valid driver's license were requested to answer questions related to traffic accidents. Results: The presence of focal seizures with impaired awareness, age, and administration of lacosamide were each shown to have a significant impact on ESS score. Furthermore, administrations of valproate and lacosamide, as well as sleep-promoting agents other than AEDs (SPA) had a significant impact on the presence of sleep disorder diagnosed with the PQSI. In view of traffic accidents in total, age and LEV had an impact on traffic accident occurrence. In view of an accident in association with an epileptic seizure, SPA was the only variable with a significant impact. As for a traffic accident not related to epileptic seizure, no factors were found to have a significant impact on that dependent variable. No correlation was found between ESS score and any of those 3 traffic accident groupings, which was also true for PSQI. Conclusions: Neither daytime sleepiness nor sleep disorder was found to be correlated with traffic accidents by PWE who drove. Furthermore, no AED was shown to be correlated with daytime sleepiness or increased risk of a traffic accident. MethodsAll patients aged 18 years or older who visited the Epilepsy Center of Aichi Medical University or Suzukake clinic from June 2016 to March 2018 and were taking AEDs regularly because of epilepsy were invited to participate in this study. Those with co-morbid intellectual disability, alcohol abuse, severe psychiatric illness, or dementia were excluded. Following approval from the Ethical Committee of Aichi Medical University (2016-H089), the patients were examined with the Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI). In addition, they were requested to answer questions related to traffic accidents, possession of a valid driving license, prior history of traffic accidents while driving, and any direct causal relationship of a traffic accident with an epileptic seizure. Only traffic accidents which occurred in the midst of or followed immediately after seizures were

In December 2022, the new guideline for evaluating the effect of psychotropic drugs on the performance to drive a motor vehicle was issued by the Ministry of Health, Labour and Welfare (MHLW) and implemented in Japan. Of the safety information, information on the influence of medications on driving performance is particularly important because it can be relevant to the social functioning of patients. In principle, the package inserts of medications are designed based on evidence and provide precautions regarding the operation of heavy machinery such as automobiles in Japan, the United States, and Europe. The effects of medications on driving performance are generally evaluated in a tiered approach involving nonclinical and clinical studies.Because of the wide variety of functional domains involved in automobile driving, the selection of evaluation methods for a given medication depends on their characteristics, which is a complicated method. Therefore, to evaluate the effects of psychotropic drugs on driving performance efficiently and appropriately, we developed the MHLW guideline that specifically defines the evaluation methods used in pharmacological studies, the neuropsychological tests used in pharmacodynamic studies, and the situations in which driving studies are necessary. Regarding the planning of appropriate drug development strategies, we review the background of the MHLW guideline and its differences from the US Food and Drug Administration (FDA) guideline.

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