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Is Seroquel a Controlled Substance?
By Your Health Magazine Health Information Team
No. Seroquel is not a controlled substance under federal law in the United States. Its active ingredient, quetiapine fumarate, is a prescription atypical antipsychotic, but it is not placed in any of the federal Controlled Substances Act schedules. A prescription is still required, and the medication has important risks that require medical supervision.
Seroquel’s Prescription and Controlled-Substance Status
The terms “prescription drug” and “controlled substance” do not mean the same thing. All controlled prescription drugs require a prescription, but many prescription medications—including Seroquel—are not controlled substances.
| Question | Seroquel or quetiapine |
|---|---|
| Is it available over the counter? | No |
| Does it require a prescription? | Yes |
| Is it federally controlled? | No |
| DEA schedule | None |
| Medication class | Atypical antipsychotic |
The current DailyMed prescribing information for quetiapine specifically lists it as “not a controlled substance.” The Drug Enforcement Administration explains that controlled drugs are divided into five federal schedules based on factors such as accepted medical use and abuse or dependence potential. Quetiapine does not appear in those schedules.
This answer concerns federal status. State prescribing systems, pharmacy procedures, insurance requirements and medication-monitoring policies can still affect how a prescription is filled.
Are Seroquel and Quetiapine Fumarate the Same Drug?
Seroquel is a brand name for quetiapine. Tablets contain quetiapine fumarate, a salt form that provides the active medication quetiapine. Generic products may therefore be labeled “quetiapine” or “quetiapine fumarate.” This wording does not make the generic version a controlled substance.
Immediate-release quetiapine and extended-release Seroquel XR deliver the medication differently. Extended-release tablets are designed to release it over a longer period and should not be crushed, split or chewed. Patients should not switch formulations or change how they take them without consulting the prescriber or pharmacist.
Checking the active ingredient and formulation is important with any medicine, especially products containing several ingredients. The same principle is discussed in this guide to understanding Brom/PSE/DM medication and its dosage.
What Is Seroquel Used For?
Quetiapine affects the activity of chemical messengers in the brain. Depending on the patient’s age, formulation and treatment plan, it may be prescribed for conditions such as schizophrenia, bipolar disorder or major depressive disorder. Some uses apply only to particular formulations or involve quetiapine being combined with another medication.
People can review consumer medication information through the MedlinePlus drug information directory. Its specific quetiapine medication guide also explains approved uses, precautions and potential side effects.
Can Seroquel Be Misused Even Though It Is Not Controlled?
Yes. A medication does not have to be federally scheduled to be misused. Quetiapine can cause sedation, and post-marketing reports and medical literature have described people taking it in ways other than prescribed. The prescribing information recommends particular caution when someone has a history of drug misuse.
Examples of unsafe use include:
- Taking medication prescribed to another person
- Taking more than prescribed or taking doses more often
- Using it mainly to produce sedation
- Combining it with alcohol or other sedating substances
- Crushing, snorting or otherwise altering the tablets
Alcohol and other central nervous system depressants may intensify drowsiness, impaired judgment and poor coordination. Patients should tell their healthcare professional about prescription drugs, nonprescription medicines, supplements, cannabis and alcohol use so that interaction risks can be reviewed.
Does Seroquel Cause Dependence or Withdrawal?
Quetiapine’s potential for abuse, tolerance and physical dependence has not been fully characterized. However, stopping it abruptly can produce discontinuation symptoms such as insomnia, nausea, vomiting, headache, dizziness, diarrhea or irritability. A return or worsening of the condition being treated is another concern.
These symptoms do not mean that every person taking Seroquel has an addiction. Addiction, physical dependence and medication discontinuation are related but distinct concepts. Patients should not stop Seroquel, restart it after an extended interruption or change the dose without guidance from the prescribing professional.
Important Safety Considerations
Not being controlled does not mean Seroquel is low-risk. Drowsiness and dizziness are common concerns, particularly when treatment begins or a dose changes. Until they know how the medication affects them, patients should use caution with driving, machinery and activities in which impaired alertness could cause injury.
Other clinically important risks can include:
- Weight gain and increased appetite
- Changes in blood sugar or cholesterol
- Low blood pressure, dizziness, fainting and falls
- Uncontrolled or repetitive body movements
- Heart-rhythm changes in susceptible people
- Rare neuroleptic malignant syndrome, a medical emergency
Quetiapine carries boxed warnings involving increased mortality in older adults with dementia-related psychosis and suicidal thoughts or behaviors in certain younger people. It is not FDA-approved to treat behavioral problems associated with dementia-related psychosis. Appropriate monitoring depends on the person’s diagnosis, age, other medications and medical history.
When to Seek Care
Contact the prescribing physician, psychiatrist or pharmacist promptly for severe drowsiness, repeated falls, fainting, uncontrolled movements, significant confusion or symptoms of high blood sugar such as unusual thirst and frequent urination. New or worsening depression, agitation, or thoughts of self-harm require urgent professional help.
Call 911 for trouble breathing, collapse, a seizure, inability to awaken the person, a severe allergic reaction, or high fever accompanied by rigid muscles, heavy sweating and confusion. For a suspected overdose in the United States, call Poison Control at 1-800-222-1222. Do not give Seroquel to anyone for whom it was not prescribed.
Bottom line: Seroquel and quetiapine fumarate are prescription medications, but they are not federally controlled substances. They should nevertheless be stored securely and used only as directed because sedation, misuse, withdrawal symptoms and serious adverse effects are possible.
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