Yes, Dayvigo (lemborexant) is a Schedule IV controlled substance.
Dayvigo is classified as a federally controlled substance (Schedule IV) by the U.S. Drug Enforcement Administration (DEA) due to its potential for abuse and dependence. 1
Regulatory Classification
The FDA-approved drug label explicitly states that DAYVIGO contains lemborexant, a Schedule IV controlled substance 1. This classification was determined based on abuse potential studies and regulatory requirements for central nervous system depressants.
Why It's Controlled
The Schedule IV designation reflects several key findings:
Abuse Potential Studies: In human abuse potential studies with recreational sedative users (n=29), lemborexant at doses of 10 mg, 20 mg, and 30 mg produced positive subjective responses on measures like "Drug Liking," "Overall Drug Liking," and "Take Drug Again" that were statistically similar to zolpidem (30 mg) and suvorexant (40 mg), and significantly greater than placebo 1
Risk Profile: Individuals with a history of alcohol or drug abuse/addiction may be at increased risk for abuse and addiction to lemborexant, requiring careful monitoring 1
Low Physical Dependence: Despite the Schedule IV classification, animal studies and clinical trials showed that chronic lemborexant administration did not produce withdrawal signs or symptoms upon discontinuation, suggesting it does not produce physical dependence 1
Clinical Implications
The controlled substance status means:
- Prescriptions are subject to DEA regulations and state-specific controlled substance laws
- The medication must be stored securely to prevent misuse and abuse
- Selling or giving away lemborexant is illegal and may harm others 1
- Healthcare providers should maintain appropriate documentation and monitoring
Real-World Abuse Risk
While classified as Schedule IV, emerging evidence suggests lemborexant and other dual orexin receptor antagonists (DORAs) may have lower real-world abuse potential than traditional Schedule IV benzodiazepines and nonbenzodiazepine hypnotics that potentiate GABA signaling 2. Internet surveillance and FDA adverse event reporting systems indicate very low abuse-related risks in the community for this drug class 2.
Bottom line: Yes, this is a controlled medication requiring appropriate prescribing practices, secure storage, and patient counseling about the risks of misuse, though its actual abuse liability in clinical practice appears relatively low compared to other Schedule IV sleep medications.