Is Trazodone a Controlled Substance? Regulation and Drug Classification

What you will learn
- Trazodone is an atypical antidepressant and selective serotonin receptor antagonist and reuptake inhibitor (SARI) that’s prescribed for anxiety, depression, and some sleep problems.
- Trazodone isn’t available over the counter, but it’s not controlled with a drug schedule like opioids, amphetamines, or benzodiazepines.
- Though trazodone is generally well tolerated, it does have the potential for misuse and some risks.
Trazodone is a widely used prescription drug for anxiety and depression disorders, such as major depressive disorder. It’s classified as an atypical antidepressant in the selective serotonin receptor antagonist and reuptake inhibitor (SARI) class of drugs.[1] Trazodone isn’t a controlled substance, but it does require a prescription and may have a risk of misuse.
What Is Trazodone?
Trazodone is an atypical antidepressant. This drug class is often used when other antidepressant treatments haven’t worked or cause side effects that can’t be tolerated. Atypical depressants are different from other antidepressants and gained their drug class.
In addition to being an atypical antidepressant, trazodone belongs to the SARI class of drugs, which work by increasing the levels of serotonin in the brain to regulate mood and relieve some symptoms of depression and anxiety. SARIs are similar to selective serotonin reuptake inhibitors (SSRIs), but they have a different mechanism of action.
Trazodone is approved by the Food and Drug Administration (FDA) to treat depression and anxiety disorders. However, it may be used off-label to treat insomnia and other sleep problems, in addiction treatment, and for other uses.
Is Trazodone a Controlled Substance?
Trazodone is not a controlled substance. Under the Controlled Substances Act, controlled substances are drugs that may or may not have legitimate medical uses but carry a risk of misuse, abuse, dependence, or addiction. There are five schedules, with Schedule I being the most strictly regulated and Schedule V being the least.[2] Drugs are scheduled based on a combination of their medical uses and addiction risks.
Trazodone has legitimate medical uses and low addiction potential, so it’s not regulated on the federal or state level. Though some cases of misuse exist, it’s not a widely abused drug like most controlled substances.
Misuse can occur with trazodone if you take the drug in ways other than prescribed. For example, taking higher doses of trazodone than prescribed, taking it more often, or taking it with other substances to get effects other than those intended – such as euphoria – are examples of misuse.
You can become dependent on trazodone, however. This is different from addiction, which is a compulsive need to use a drug despite problems it may cause. Dependence happens when your body gets used to the drug and needs it to function normally. If you stop suddenly or reduce your dose, withdrawal symptoms may occur.
Trazodone Dosage
Trazodone has different doses based on what it’s prescribed to treat. Typically, trazodone has a dose of 150 mg per day in divided doses with a maximum dose of 400 mg daily.[3] The extended-release (ER) version is dosed at 150 mg daily in a single dose with a maximum dose of 375 mg daily.[4] Your doctor may adjust the standard dosages for off-label use until you find relief.
It’s crucial always to take your medication as prescribed and follow your doctor’s recommendation. Taking trazodone in ways other than prescribed increases the risk of serious side effects.
Side Effects of Trazodone
Trazodone has some common side effects, including:[5]
- Drowsiness
- Dizziness
- Lethargy
- Blurred vision
- Swelling (edema)
- Weight loss
- Diarrhea
- Constipation
- Nasal congestion
Though rare, there is a risk of serious side effects, including:[6]
- Fast heart rate
- Slow heart rate
- Bruising
- Low sodium
- Mood changes
- Suicidal thoughts or actions
- Severe allergic reaction (difficulty breathing, swelling of the lips, mouth, tongue, or throat)
In rare cases, trazodone can cause serotonin syndrome.[7] This dangerous condition occurs when serotonin builds up in the brain and causes symptoms like sweating, fever, agitation, shivering, muscle stiffness, nausea, vomiting, diarrhea, and poor coordination.
Trazodone Overdose
Like any drug, it’s possible to overdose on trazodone if you take a higher dose than your body can process. Trazodone overdose symptoms can include:[8]
- Fast or pounding heartbeat
- Seizure
- Painful or prolonged erection
- Slow or stopped breathing
- Vomiting
Misusing trazodone or using it with depressants like alcohol, opioids, sedatives, or barbiturates can quickly turn fatal.
Trazodone Withdrawal
Trazodone isn’t addictive in the same way as opioids or alcohol, but it can cause dependence with regular use or misuse. Suppose you’ve been taking trazodone at high doses or for long periods and stop suddenly. In that case, you may experience withdrawal symptoms like numbness, tingling, confusion, sweating, agitation, vomiting, dizziness, or feelings like electric shocks in your body.[9]
Never stop taking trazodone or reduce your dose on your own. Your doctor can tell you how to stop taking this drug safely, which may require a taper schedule that “weans” you off the current dosage and reduces the risk of withdrawal symptoms.
Is Trazodone Safe?
Trazodone is widely used because it’s generally safe and well tolerated, especially compared to some other prescription drugs. It’s not a controlled or addictive substance, so it can be a good choice for people who need effective management of anxiety, depression, insomnia, or other conditions. However, there is some risk of misuse and dependence, so it’s important to take trazodone exactly as prescribed to reduce the risk.
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Frequently Asked Questions About Trazodone Classification
Can Trazodone Be Used for Insomnia?
One of the common off-label uses for trazodone is for sleep problems like insomnia. The drug causes drowsiness, which can help people who struggle to sleep or stay asleep. However, it’s not an effective insomnia treatment for everyone, so talk to your doctor before using trazodone for this purpose.
Does Trazodone Work Immediately?
Trazodone can have different effects depending on what it’s treating, the dosage, and other factors. For anxiety and depression, it can take a few weeks before you see results. For conditions like insomnia, trazodone tends to cause drowsiness quickly. Talk to your doctor if you don’t see results from the drug after taking it for several weeks.
Is Trazodone Safe to Take with Alcohol?
Trazodone and alcohol both have depressant effects. Combining them can cause serious side effects like slow or stopped breathing and losing coordination. Ask your doctor when it’s safe to drink alcohol after taking trazodone and for information about other drug interactions.
What Makes Trazodone Different from Other Antidepressant Medications?
Trazodone is an atypical antidepressant in the SARI class of drugs. It’s different from selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), which are commonly prescribed for depression and anxiety to influence serotonin levels in the brain.
[1] Trazodone uses, dosage, side effects & warnings. Drugs.com. (n.d.-g). Retrieved from https://www.drugs.com/trazodone.html on 2025, January 13.
[2] Controlled Substances & CSA Schedule lists. Drugs.com. (n.d.). Retrieved from https://www.drugs.com/csa-schedule.html on 2025, January 13.
[3] Mayo Foundation for Medical Education and Research. (2023, December 1). Trazodone (oral route) proper use. Mayo Clinic. Retrieved from https://www.mayoclinic.org/drugs-supplements/trazodone-oral-route/proper-use/drg-20061280 on 2025, January 13.
[4] Mayo Foundation for Medical Education and Research. (2023, December 1). Trazodone (oral route) proper use. Mayo Clinic. Retrieved from https://www.mayoclinic.org/drugs-supplements/trazodone-oral-route/proper-use/drg-20061280 on 2025, January 13.
[5,6,7,8,9] Trazodone uses, dosage, side effects & warnings. Drugs.com. (n.d.-g). Retrieved from https://www.drugs.com/trazodone.html#side-effects on 2025, January 13.