| Title： | Chinese expert consensus on clinical use of wake-promoting drugs |
| Edition： | Original |
| Classification： | Experts consensus |
| Field： | Treatment |
| Countries and regions： | China |
| Guidelines users： | The consensus is intended for clinical workers involved in clinical practice with wake-promoting drugs in EDS patients, catering to professionals in sleep medicine and related fields, as well as non-sleep medicine specialists |
| Evidence classification method： | Using the Oxford Centre for Evidence-based Medicine (CEBM) Levels of Evidence to evaluate the quality of evidence and grade recommendations |
| Development unit： | Sleep Disorders Special Committee of the Chinese Sleep Research Society |
| Registration time: | 2024-03-26 |
| Registration number： | PREPARE-2024CN467 |
| Purpose of the guideline: | Excessive Daytime Sleepiness (EDS) refers to the inability of an individual to maintain the necessary alertness and wakefulness during the day, leading to excessive sleep needs or involuntary sleep onset. EDS is often a consequence of sleep deprivation, poor nighttime sleep, other sleep disorders such as obstructive sleep apnea (OSA) and circadian rhythm disturbances. EDS can also be a core symptom of central hypersomnia disorders like narcolepsy, idiopathic hypersomnia, and Kleine-Levin syndrome. Additionally, it may result from neurodegenerative diseases, psychiatric disorders, endocrine disorders, respiratory diseases, or certain medications. In the United States, the prevalence of EDS in adults is 23.34%, more common in younger women, individuals with low income or unemployment, and often associated with psychiatric disorders or chronic diseases. In Chinese children and adolescents, the prevalence of EDS is 29.2%, varying from 19.8% before puberty to 47.8% after puberty. The prevalence of EDS in the elderly is relatively lower, with a rate of 9.3% in rural Chinese populations aged 65 and above, peaking at ages 65-69 and decreasing with age. EDS significantly disrupts patients' daily lives, work, study, and social interactions. Surveys indicate that EDS contributes to traffic accidents annually, ranking just below accidents caused by nighttime fatigue driving and drunk driving. healthcare workers with EDS may also face increased risks of medical errors[8]. Moreover, EDS is associated with an increased risk of cardiovascular, mental health and neurodegenerative diseases as well as mortality. The etiology of EDS is complex and highly heterogeneous, potentially persisting for several years and requiring individualized interventions. Treatment for EDS include non-pharmacological and pharmacological therapies targeting underlying causes or symptoms of EDS. Wake-promoting drugs are a primary approach to improving EDS symptoms other than intervening in primary diseases. These drugs are categorized into approved indications for EDS and off-label applications. In China, modafinil and pitolisant are already approved for EDS. More wake-promoting agents may receive approval in the future such as solriamfetol which has initiated Phase III clinical trials for EDS due to OSA in China. Additionally, there are off-label applications of methylphenidate and amphetamine. Given the high prevalence and risks associated with EDS, intervention management is crucial. The current Chinese consensus guidelines for EDS focus on comprehensive management without specific consensus on the clinical application of wake-promoting drugs. Considering the approval of wake-promoting agents for EDS in China and the increasing variety of approved agents along with off-label treatments available, there is a lot unmet clinical needs regarding wake-promoting drugs by establishing standardized clinical guidelines for their use. Therefore, this consensus aims to provide unified guidance on drug selection for EDS, initiation criteria, treatment strategies, personalized therapy approaches, safety monitoring, and potential directions for future research. |
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