Is Trazodone a Controlled Substance? Understanding Your Concerns About This Medication

If you’re wondering whether trazodone is a controlled substance, you’re probably feeling some concern about what this medication means for you. That’s completely understandable. Many people worry about addiction potential, stigma, or being judged for taking medication. These concerns are valid, and you deserve clear, honest information to make informed choices.

The straightforward answer: Trazodone is not a controlled substance according to the FDA or DEA. However, recent large-scale research has raised concerns about its abuse potential, causing medical organizations to caution against its most common off-label use. Everyone’s situation is different, and working closely with your healthcare provider is essential for determining what’s right for you.

Medical disclosure: Trazodone is FDA-approved only for depression. Its use for sleep disorders is off-label and is not recommended by the American Academy of Sleep Medicine, American College of Physicians, or VA/DoD clinical guidelines due to limited evidence and safety concerns. This information is for educational purposes only and not a substitute for medical advice. Always consult your healthcare provider about your specific situation.

Quick Facts About Trazodone

• NOT a controlled substance
• Recent 2025 data suggest that abuse potential is higher than previous studies indicated
• FDA-approved ONLY for depression
• Major medical organizations recommend AGAINST off-label use for sleep
• Requires prescription and close monitoring

Why People Ask This Question (And Why Your Concerns Matter)

When you search “Is trazodone a controlled substance?” you’re not just asking about legal classification. You’re asking about safety, stigma, and long-term impact.

Common worries include:

• “Will I become dependent on this?”
• “Will this medication work for me?
• “Is it like those addictive medications I’ve heard about?”

These questions are reasonable, valid, and responsible. Asking them shows you’re taking an active role in your healthcare and wellbeing. 

The Official Answer: What “Controlled Substance” Really Means

Aspect	Controlled Substances	Trazodone
Legal Status	Regulated by DEA Schedules I-V	Not controlled, prescription required
FDA Approval	Various approved uses	Approved only for depression
Recent Safety Data	Significant dependency concerns	A 2025 study found reports of possible trazodone misuse in real-world data.This doesn’t mean the drug is addictive; it just means experts are monitoring it more closely
Professional Guidelines	Varies by medication	Strongly oppose off-label use for sleep
Prescription Rules	Special regulations, limited refills	Standard prescription process
Individual Risk Factors	Higher dependency concerns	Risk profile under review based on recent data

Key point: The FDA does not classify trazodone as a controlled substance [1]. But new safety data shows risks that deserve careful monitoring.

What Recent Research Shows About Trazodone’s Safety Profile

Early Studies (1990s–2000s):
A small 1999 trial of 10 men with substance use history suggested trazodone had relatively low abuse potential compared with benzodiazepines [3].

• Limitations: very small sample, only male participants, and short study duration.
  

Recent Large-Scale Evidence (2025):
A pharmacovigilance study of 5,199 patients identified “drug abuse” as a significant adverse event with trazodone [8].

• Additional risks flagged: reports include serious events such as cardiac or respiratory arrest and suicide, though these remain rare and require further investigation.
  
• Clinical takeaway: Trazodone isn’t classified as a controlled substance, but recent studies show it may have more side effects and risks than doctors once thought, especially when used for sleep.

Professional Medical Organization Positions: What You Need to Know

 Insomnia (most common off-label use):

• American Academy of Sleep Medicine: “Insufficient evidence; do not recommend trazodone.” [10]
  
• American College of Physicians: Recommended against trazodone for sleep in clinical guidelines.
  
• VA/DoD: Advised against trazodone due to low-quality evidence and safety concerns.
  
• Cochrane Reviews: Found no robust evidence supporting trazodone for insomnia.
  

FDA-Approved Use (Depression):

• Approved for depression only, effective at 150–600 mg [6].
  
• For sleep, lower doses (25–100 mg) are widely prescribed off-label despite guideline opposition.
  
• Critical distinction: The FDA has only approved trazodone for depression. All other uses are off-label.
  

How Trazodone Works (In Plain English)

• Belongs to the SARI (serotonin antagonist and reuptake inhibitor) class [4].
  
• At antidepressant doses (150–600 mg): improves mood by regulating serotonin.
  
• At lower doses (25–100 mg, off-label): works mainly through sedation, which explains its common—but professionally discouraged—use for sleep.
  
• In everyday terms: Trazodone is a type of antidepressant that changes how your brain uses serotonin, a chemical that affects mood, sleep, and anxiety. At higher doses, it helps treat depression by balancing serotonin levels.  At lower doses, it mainly makes you sleepy, which is why some doctors prescribe it for sleep — even though major medical groups don’t recommend it for that purpose.

Individual Factors That May Affect You:

Factor Category	What to Consider	How It Affects You	Questions for Your Provider
Medical History	Heart problems, liver issues, previous reactions	May significantly influence safety and monitoring needs	“Given my [condition], is trazodone safe for me?”
Current Medications	Blood thinners, antidepressants, heart medications	Potentially dangerous interactions require careful review	“How will trazodone interact with my current medications?”
Treatment Goals	Depression (FDA-approved) vs. sleep (off-label, opposed by guidelines)	Determines if use aligns with medical evidence	“What FDA-approved alternatives exist for my condition?”
Risk Factors	History of substance use, cardiac issues, respiratory problems	Recent data shows increased risk profile	“Am I at higher risk for the serious adverse events reported?”

Why this matters: Work with a provider who understands your full history and keeps up with the latest research.

Addressing Real-World Concerns

Common Worries and Current Evidence

Immediate Concern	Current Information	Next Steps
“Will I be judged?”	Not a controlled substance, but safety concerns exist	Discuss both benefits and new safety data
“Drug test worries?”	Not on standard screenings	Clarify with employer if concerned
“Family questions?”	You control what you share	Explain that trazodone is FDA-approved for depression, but off-label for sleep with guideline concerns
“Safety concerns?”	Recent data show risks (cardiac, respiratory, abuse potential)	Discuss your individual risk factors with your provider

Specific Guidance:

• Drug tests: Trazodone usually won’t appear on standard screenings.
  
• Family explanations: You can frame it as an antidepressant FDA-approved for depression. If prescribed for sleep, note that professional guidelines caution against this use.
  
• Safety concerns: 2025 data highlight risks like cardiac arrest, respiratory arrest, and drug abuse—making it essential to personalize risk discussions with your provider.
  

Working Effectively With Your Healthcare Provider

Before your appointment:

• Research recent safety data and guideline positions.
  
• Write down your questions and concerns.
  
• Note your full medication history and risk factors.
  

During your appointment:

• Share specific concerns about safety data.
  
• Ask why trazodone is recommended over guideline-supported alternatives.
  
• Request a monitoring plan for serious risks.
  

After your appointment:

• Revisit the decision considering guidelines and personal risks.
  
• Monitor closely for side effects and take note of any changes you observe
  
• Plan regular check-ins.
  

Questions to Ask:

• “Major medical organizations recommend against trazodone for sleep—why are you recommending it?”
  
• “What’s my personal risk for the serious adverse events reported in 2025 studies?”
  
• “What evidence-based alternatives exist for sleep or depression?”
  
• “How will we monitor for heart, respiratory, or safety concerns?”
  
• “Is this prescription for FDA-approved depression treatment or off-label sleep use?”
  

Tip: If your provider dismisses your concerns, consider seeking a second opinion.

When to Contact Your Provider Immediately

Emergency Situations:

• Chest pain, irregular heartbeat, or severe dizziness
  
• Breathing difficulties or respiratory distress
  
• Thoughts of self-harm or suicide
  
• Prolonged/painful erections (men)
  
• Loss of consciousness or sudden confusion
  

Concerning Symptoms:

• Craving or misusing medication
  
• Heart rhythm changes
  
• Falls or severe balance issues
  
• Side effects interfering with daily life
  

Routine Monitoring:

• Questions about new safety data
  
• Ongoing concerns about effectiveness
  
• Interest in guideline-supported alternatives

Moving Forward With Complete Information

• Not a controlled substance (true).
• Recent large-scale research shows higher risks than once thought.
  
• Professional consensus: trazodone should not be used for insomnia.
  
• FDA approval remains limited to depression.
  

Next steps for you:

• Talk with a provider who stays current on evidence.
• Ask about alternatives with stronger guideline support.
  
• Clarify whether your use is FDA-approved (depression) or off-label (sleep).
  

Final takeaway: Understanding both the benefits and updated risks of trazodone puts you in the best position to make safe, informed choices about your mental health care.

You deserve care based on the most current evidence and professional guidelines. Whether you’re considering trazodone or exploring other treatment options, you don’t have to navigate these complex decisions alone.

At PsychPlus, our healthcare providers stay current with the latest research and professional guidelines to help you make fully informed decisions. We understand that medication choices can feel overwhelming, especially when recent research updates our understanding of risks and benefits.

Ready to discuss your options with providers who consider both current evidence and professional guidelines? Contact PsychPlus to schedule a consultation focused on evidence-based treatment approaches that align with current medical standards.

References 

[1] U.S. Food and Drug Administration. TRAZODONE hydrochloride tablets USP, for oral use. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf

[2] Drugs.com. Is trazodone a controlled substance? Medical Answers. 2021. https://www.drugs.com/medical-answers/trazodone-controlled-substance-3561217/

[3] Rush CR, Baker RW, Wright K. Acute behavioral effects and abuse potential of trazodone, zolpidem and triazolam in humans. Psychopharmacology (Berl). 1999 Jun;144(3):220-33. https://pubmed.ncbi.nlm.nih.gov/10435388/

[4] Shin JJ, Saadabadi A. Trazodone. StatPearls. Updated 2024 Feb 29. https://www.ncbi.nlm.nih.gov/books/NBK470560/

[5] DrugBank. Trazodone: Uses, Interactions, Mechanism of Action. 2024. https://go.drugbank.com/drugs/DB00656

[6] Fagiolini A, Comandini A, Catena Dell’Osso M, Kasper S. Rediscovering trazodone for the treatment of major depressive disorder. CNS Drugs. 2012 Dec;26(12):1033-49. https://link.springer.com/article/10.1007/s40263-012-0010-5

[7] U.S. National Library of Medicine. Trazodone: MedlinePlus Drug Information. 2024. https://medlineplus.gov/druginfo/meds/a681038.html

[8] Scientific Reports. A realworld pharmacovigilance study of trazodone based on the FDA adverse event reporting system. Nature. 2025 Feb 13. https://www.nature.com/articles/s41598-025-89632-7

[9] Jaffer KY, Chang T, Vanle B, et al. Trazodone for Insomnia: A Systematic Review. Innov Clin Neurosci. 2017;14(7-8):24-34. https://pmc.ncbi.nlm.nih.gov/articles/PMC5842888/

[10] Sateia MJ, Buysse DJ, Krystal AD, et al. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(2):307-349. https://jcsm.aasm.org/doi/10.5664/jcsm.6470