The overlooked vital sign: The importance of measuring sleep in drug development studies

Sleep is rarely considered in drug development studies. Pre-existing sleep problems or changes in sleep parameters in response to therapeutics have the potential to diminish the true utility of the agent under development. Sleep is integral to human health and affects virtually every disease. We present evidence that indicates how sleep quality and quantity can be predictive of disease risk, progression, remission, and recurrence. Supporting the premise that we should conceptualize sleep as a `vital sign' and measure sleep as an integral component in drug development. We highlight the emergence of digital health technologies that have enabled the capture of this `vital sign' and ask the question: why is sleep still largely ignored in drug development studies?

Automated summary

Sleep is seldom taken into account in drug development studies, despite it being crucial to human health and predictive of disease risk and progression. It is proposed that sleep should be conceptualized as a vital sign and measured as an integral component in drug development.