Abstract
STUDY OBJECTIVES: This review describes the legal and regulatory landscape surrounding controlled substance prescribing in sleep medicine, focusing on the Controlled Substances Act, Drug Enforcement Agency, and best practices. It explores abuse and dependence risks associated with these medications and addresses telemedicine and e-prescribing considerations. METHODS: We synthesized information from the Controlled Substances Act, Drug Enforcement Agency, Centers for Disease Control and Prevention, Federation of State Medical Boards, peer-reviewed medical literature, and professional organizational position statements regarding controlled substances in sleep medicine. RESULTS: Managing controlled substances in sleep medicine necessitates careful consideration of Drug Enforcement Agency scheduling, regulatory requirements, and potential risks. Opioids pose a risk of dependence or abuse, but the lower doses used in sleep medicine may mitigate this risk. There is less evidence available regarding the abuse potential of stimulants. Hypnotics and benzodiazepines require cautious prescribing due to the potential for long-term use by patients and possibility of dose escalation. Oxybates are subject to strict risk evaluation and mitigation strategy programs. Best practices include comprehensive patient evaluations, thorough risk assessments, prescription drug monitoring program checks, and transparent patient communication. Telemedicine prescribing is governed by strict regulatory statutes, with temporary exceptions currently in place. CONCLUSIONS: Controlled substances are vital for managing various sleep disorders. Balancing patient access to effective medications while minimizing abuse and diversion is crucial. Further research is needed to refine risk assessment tools and develop standardized protocols, particularly for nonopioids. The evolving role of telemedicine and e-prescriptions requires ongoing evaluation and adaptation of practices to ensure patient safety and regulatory adherence. CITATION: Kolla BP, Silber MH, Rushlow DR, Ramar K, Mansukhani MP. Prescribing controlled substances in sleep medicine clinics: an overview of legal issues and best safety practices. J Clin Sleep Med. 2025;21(10):1799-1807.