Prescription stimulants are classified as Schedule II drugs under the Controlled Substances Act and associated with serious risks, including misuse, addiction, overdose, and diversion. Stimulants are an area of great interest given that the number of prescriptions has nearly doubled from 2011 to 2022 (FDA DSC, 2023), with the greatest increase in adults (CDC MMWR, 2023). FDA’s Overdose Prevention Framework strives to address the impact of stimulants-related issues as part of a comprehensive approach to address a public health concern. Using this framework, FDA intends to strike a balance between supporting access to safe and effective medications and preventing the negative consequences of nonmedical use.
- FDA awards National Academies of Sciences, Engineering, and Medicine (NASEM) with grant toward workshop examining diagnosis and treatment of ADHD in Adults
- FDA Requires Updates to Clarify Labeling of Stimulant Medications
- White Paper on A Research Agenda for Developing Stimulant Use Disorder Treatment
Supporting Primary Prevention
When used appropriately, FDA-approved prescription stimulants can provide significant benefits for patients, such as improving attention in people with attention deficit/hyperactivity disorder (ADHD), reducing excessive overeating episodes in people with binge eating disorder, and increasing wakefulness in people with uncontrollable episodes of deep sleep (narcolepsy). FDA has taken important steps to increase access to diverse treatment options for ADHD, including digital and non-stimulant drug options. FDA is also promoting safe use and appropriate prescribing of stimulants by funding research to inform prevention of prescription stimulant misuse, addiction, and overdose. Additionally, FDA has awarded the National Academies of Sciences, Engineering, and Medicine (NASEM) with a grant toward a workshop that will examine the diagnosis and treatment landscape of ADHD in adults.
- FDA Updating Warnings to Improve Safe Use of Prescription Stimulants
- FDA Funds University of Michigan Research Project on Stimulant Use Disorder Trajectories
Encouraging Harm Reduction
FDA is working to increase awareness about the risks associated with nonmedical use of prescription stimulants. To accomplish this, FDA collaborates with federal partners to educate the public about the risks related to prescription stimulants, including side effects (e.g., anxiety, insomnia) and risk of addiction. Most fatal overdoses involving a stimulant also involve an opioid, and FDA has taken actions to help expand availability of life-saving opioid overdose reversal drugs. To aid this effort, FDA held a public workshop to inform product development and public health interventions to manage overdoses.
- Information about Naloxone and Nalmefene
- FDA Hosts Public Workshop to Understand and Manage Overdose
Evidence-Based Treatments for Stimulant Use Disorders
FDA is supporting innovation in treatment development for stimulant use disorders. As there are currently no FDA-approved pharmacological treatments for stimulant use disorders, FDA is working to accelerate their development, including through public workshops and the publication of a meeting summary on research recommendations.
- A Research Agenda for Developing Stimulant Use Disorder Treatment
- Public Meeting on Patient-Focused Drug Development for Stimulant Use Disorder
- Public Workshop on Practical Research Agenda for Treatment Development for Stimulant Use Disorder
Protecting the Public from Unapproved, Diverted, or Counterfeit Drugs Presenting Overdose Risks
FDA has developed resources on purchasing prescription medications online through BeSafeRx to help ensure access to medications from a safe source. Additionally, FDA is proactively working to address controlled substances illegally sold online. To reduce the risks presented by excess prescription medication, FDA has developed resources on safe drug disposal.
- FDA Consumer Updates: How to Buy Medicines Safely from an Online Pharmacy
- FDA Issues Warning Letters to Website Operators Illegally Selling Prescription Stimulants
- FDA Hosts Summits Focused on Preventing the Illegal Online Opioids Sales
- Dealing with ADHD: What You Need to Know
- Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
- FDA Overdose Prevention Framework
- Controlled Substances Program