Prescription stimulant dispensing in the U.S. increased 58% from 2012 to 2022, with a threefold rise among adults aged 31 to 40 years, according to a recent JAMA Psychiatry Viewpoint. Since October 2022, ongoing shortages of these medications have created barriers for patients with attention-deficit/hyperactivity disorder and other conditions.
The Viewpoint, authored by Robert M. Califf, MD, Commissioner of the FDA, and Joshua P. Rising, MD, MPH, of Rising Health Strategies and the FDA, noted that the greatest surge in stimulant dispensing occurred between 2021 and 2022, coinciding with the COVID-19 pandemic and relaxed regulations around telemedicine prescribing. Adult prescriptions increased significantly, while pediatric prescribing remained relatively stable during the same period.
Stimulants such as mixed amphetamine salts, methylphenidate, and lisdexamfetamine are Schedule II controlled substances and subject to Drug Enforcement Administration (DEA)–set manufacturing quotas. These quotas decouple traditional supply-demand dynamics and may contribute to shortages if not fully met or equitably distributed. Additional contributing factors may include delays in quota allocation, underutilization by manufacturers, and increased distributor caution following opioid-related litigation.
To address these shortages, the FDA has partnered with the DEA and other federal agencies to assess appropriate use, communicate the risks of nonmedical use, and mitigate disruptions. The FDA has funded evidence reviews through the Agency for Healthcare Research and Quality and supported a National Academies of Medicine workshop, which highlighted diagnostic and treatment challenges for adult attention-deficit/hyperactivity disorder and the absence of formal clinical guidelines.
Despite the increase in prescribing, data do not suggest a proportional rise in nonmedical stimulant use. The 2023 National Survey on Drug Use and Health estimated that 3.9 million individuals aged 12 years and older reported past-year nonmedical use. Available evidence indicates that sporadic use, often for performance enhancement, is the most common nonmedical pattern.
The FDA continues to monitor stimulant use and outcomes using data sources such as proprietary drug utilization databases and the Sentinel Initiative. Stimulant product labeling includes a boxed warning about the risks of misuse and addiction, updated in 2023 to ensure consistency across the drug class. Although the DEA increased quotas for methylphenidate and lisdexamfetamine in 2023 and 2024, shortages persist. According to the authors, the FDA remains engaged in collaborative efforts to alleviate these shortages while supporting access to appropriate treatment.
Full disclosures appear in the original Viewpoint.