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Central Nervous System Stimulants & Patient Characteristics and Utilization

    Basic Details
    Status
    Complete
    Last Updated
    Tuesday, October 7, 2025
    Original Posting Date
    Health Outcome(s)
    patient characteristics
    utilization
    Purpose
    Drug Utilization
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No
    Study Summary

    The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to evaluate utilization of Schedule-II (C-II) stimulant drugs labeled to treat attention-deficit/hyperactivity disorder (ADHD), in light of increasing C-II stimulant use in adults since 2000, which accelerated during the COVID-19 pandemic.1 FDA also sought to gain a clearer understanding of utilization patterns and characteristics of patients starting C-II stimulant therapy, having seen reports of concomitant prescribing of ADHD stimulants with sedative/hypnotic medications or with other psychoactive medications.2

    This study assessed baseline characteristics and use patterns of adults starting C-II stimulants from January 2017 to March 2023. Results found the average cumulative treatment duration was approximately six months. A substantial number of patients had observed cumulative treatment duration less than one year. The average daily dose, calculated over all dispensings of each commonly prescribed C-II stimulant, was generally typical of routine clinical practice. Use patterns and baseline diagnoses did not meaningfully differ in the pandemic and pre-pandemic periods. The results of this study provided descriptive information that informed the design of studies assessing risks associated with ADHD stimulant use.