Sofrel

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Sofrel

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Sofrel

What is Sofrel? A Foundational Overview

Property Description
Active ingredient Quetiapine fumarate
Form Oral tablets (standard and extended-release)
Pharmacological class Atypical Antipsychotic (Psychotropic agent)
Common use Mood and thought stabilization
Origin Synthetic compound (Dibenzothiazepine derivative)

Sofrel: An Atypical Antipsychotic Medicine

Sofrel is a synthetic psychotropic agent containing the active ingredient Quetiapine fumarate. It is classified as an atypical antipsychotic medicine, a category that is clinically recognized for its refined action compared to first-generation treatments. This compound is part of the dibenzothiazepine derivatives chemical class. The atypical classification signifies the drug's dual mechanism of action, which involves modulating both dopamine and serotonin neurotransmitter systems. This action relates to adjusting chemical activity in the brain. Sofrel is a prescription-only drug, typically intended for adults, making it distinct from over-the-counter preparations.


Composition and Available Forms of Quetiapine

The medicine is available for oral administration as a solid tablet. The formulation contains the active compound Quetiapine fumarate embedded within an inert excipient matrix. Sofrel is supplied in two primary dosage forms: a standard oral tablet for immediate release and an extended-release oral tablet (XR). The extended-release form is specifically engineered to provide a gradual, continuous delivery of the active ingredient over a long period. This sustained-release feature is a differentiating factor from standard formulations, designed to help maintain stable drug concentrations in the body for consistent patient stability.


General Purpose: Stabilizing Thought and Mood

The primary purpose of Sofrel is to promote emotional and psychological stability in individuals experiencing certain mental health conditions. The active ingredient achieves this by modulating the activity of chemical messengers in the brain. The drug’s complex pharmacological action is utilized to help normalize disorganized thought processes and regulate intense mood states. A typical use scenario involves stabilizing a person's mood to promote clear thinking and emotional equilibrium.

Regulatory References

  1. United States National Library of Medicine (NIH)

What side effects are possible with Sofrel?

Possible Side Effects and Safety Information

The safety characteristics of Sofrel (Quetiapine fumarate) are documented and classified by government regulatory authorities based on observed frequency and effects on body systems. This section details the adverse reactions and high-level safety constraints as listed in official prescribing information.

Frequency-Classified Adverse Reactions

The following are examples of adverse reactions listed in official documents:

Classification Examples of Documented Effects
Very Common (ge 1/10) Somnolence, Dizziness, Dry mouth, Weight gain, Elevated serum lipids.
Common (ge 1/100 to < 1/10) Tachycardia, Orthostatic hypotension, Constipation, Extrapyramidal symptoms, Leukopenia.
Uncommon (ge 1/1,000 to < 1/100) Seizures, Prolongation of the QT interval, Diabetes mellitus, Neutropenia.

Serious Adverse Reactions and Safety Constraints

Official labeling highlights several serious adverse reactions and safety considerations. Metabolic changes are a key focus, including the risk of significant weight gain, hyperglycemia that may lead to diabetes mellitus, and dyslipidemia. Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia are also documented as potential serious reactions.

Regulatory documents include specific warnings for patient populations. For older adults with dementia-related psychosis, use of Sofrel is associated with an increased risk of mortality. In children, adolescents, and young adults (up to age 24), there is a documented increased risk of suicidal thoughts and behavior.

Safety patterns linked to treatment duration are also noted: Somnolence and orthostatic hypotension are effects that may be more common at the start of treatment, whereas the formation of cataracts is associated with long-term exposure. Furthermore, the medicine is contraindicated for use with potent inhibitors of the CYP3A4 enzyme.

Overdose and Emergency Response

Overdose and When to Seek Help

Official labeling for Sofrel (Quetiapine fumarate) outlines specific clinical signs of overexposure, which often represent an exaggeration of the drug's known physiological effects. The most frequently documented manifestations of overdose include profound drowsiness (somnolence) and cardiovascular changes such as tachycardia (rapid heart rate) and hypotension (low blood pressure), including orthostatic effects. Ingestion of high doses, particularly over 3 grams, is associated with a greater risk of severe toxicity.

Regulators emphasize the potential for serious and life-threatening outcomes. These complications include respiratory depression requiring ventilatory support, coma, seizures, and QT prolongation, which can lead to serious cardiac arrhythmias. Fatal outcomes have been reported, especially in cases of massive overdose or in individuals with pre-existing severe cardiovascular disease.

Immediate medical attention is required for any suspected overdose. Management is uniformly described as symptomatic and supportive, as no specific antidote is known. Emergency procedures outlined in regulatory documentation include ensuring adequate airway management, providing necessary oxygenation, and administering IV fluids or appropriate vasopressors (excluding Epinephrine) to treat circulatory instability. Continuous cardiac monitoring via ECG is mandated for an extended period to observe for cardiac toxicity.

Therapeutic Uses of Sofrel

What Sofrel Treats: Main Uses and Benefits

Sofrel is commonly used across conditions characterized by periods of heightened symptoms in key psychiatric domains, with a focus on symptom management and supportive relief for long-term symptom management.

Common applications include the treatment of Schizophrenia, the management of acute manic and depressive episodes associated with Bipolar Disorder, and use as an adjunctive therapy for Major Depressive Disorder (MDD).

The medication helps address symptom clusters that may become intense or disruptive, such as hallucinations, delusions, and extreme shifts in mood and energy. This use provides support that helps ease the overall symptom burden.

“The primary goal is to support the patient during difficult episodes by easing distress and assisting with maintaining functional stability.”

Quick Fact: Relief for Disorganized Thought Sofrel is applied in clinical settings that involve acute or unstable symptom patterns where temporary assistance in symptom management is important. It contributes to improved comfort during periods of heightened symptoms by helping to manage cognitive disturbances and extreme mood states.

Regulatory References

  1. DailyMed (NIH) Official Labeling Summary

Eligibility and Restrictions for Use

Who can and cannot use Sofrel?

The eligibility for Sofrel (Quetiapine fumarate) is strictly defined by regulatory authorities to ensure safe and appropriate use. Patient populations are classified as eligible, conditionally restricted, or prohibited based on official labeling.


Eligibility Scope

Classification Population or Condition
Contraindicated Patients with known hypersensitivity to Quetiapine fumarate or its components.
Prohibited Use Elderly patients with dementia-related psychosis (due to increased mortality risk).
Approved Ages Adults (18+), Adolescents (13–17) for Schizophrenia, and Children (10–17) for Bipolar I manic episodes.
Conditional Use Patients with hepatic impairment require a lower starting dose.
Caution Required Patients with known cardiovascular disease or a history of seizures.
Use Not Established Children younger than 10 years of age for any approved indication.

Pregnancy and Lactation Status

Use during pregnancy is considered conditional, permitted only if the potential benefit justifies the potential risk to the fetus. Since Quetiapine is excreted into human milk, regulatory guidelines recommend a decision to discontinue the drug or discontinue nursing.

What should I know about interactions with other medicines?

The official interaction profile for Sofrel (quetiapine fumarate) is governed primarily by metabolic and pharmacodynamic factors, as documented in regulatory prescribing information.

Metabolic and Contraindicated Combinations

The drug’s clearance is managed mainly by the CYP3A4 enzyme. Co-administration with strong CYP3A4 inhibitors, such as ketoconazole or ritonavir, is formally contraindicated due to the potential for a significant increase in Sofrel's plasma concentrations. Conversely, co-administration with strong CYP3A4 inducers like phenytoin, carbamazepine, or St. John's wort can substantially reduce the drug's plasma exposure. Regulatory documents specify that a dose reduction (to one-sixth) is required when a strong inhibitor is added, and a dose increase (up to five-fold) may be needed when a strong inducer is initiated.

Additive and Substance Effects

Official labeling notes that using Sofrel concomitantly with other centrally acting drugs or alcohol can result in additive effects, potentially increasing somnolence and dizziness. Additionally, co-administration with antihypertensive agents may enhance blood pressure-lowering effects, increasing the risk of orthostatic hypotension. For the extended-release formulation, a dietary constraint applies: it should be taken without food or only with a light meal, as a large meal significantly increases the drug's systemic exposure. Reduced clearance in individuals with hepatic impairment is noted in regulatory sources, making the effects of co-administered agents potentially more pronounced in this population.

Mechanism of Action

Targeting Core Cellular Survival Pathways

Sofrel acts primarily as an intracellular kinase inhibitor, specifically modulating the activity of key enzymes within the MAPK/ERK and PI3K/AKT/mTOR signaling pathways. This core mechanism involves disrupting the phosphorylation cascade, which normally transmits signals for cell growth and survival, leading to a profound shift in cellular signaling dynamics.


Interrupting Proliferation Signals and Inducing Apoptosis

By fracturing these critical signal transduction pathways, Sofrel halts the instructions for cell division and growth. This failure to maintain pro-survival signals ultimately results in the induction of apoptosis (programmed cell death), which is the primary physiological consequence. The resulting cellular environment reflects decreased pro-survival signaling, leading to the reduction of proliferating cell populations.


Modulating Gene Expression for Cell Fate

The suppression of these signaling cascades prevents the activation and nuclear translocation of certain Transcription Factors (TFs), such as STAT3. This modulates the expression of genes vital for cell survival and proliferation. This further contributes to the overall physiological consequences of the mechanism, resulting in physiological adjustments that favor cell cycle arrest and apoptosis.

Dosage and Administration Information

How Sofrel is Used: Administration Guidelines

Sofrel (quetiapine fumarate) is administered orally and according to a specific dosing schedule, which includes a mandatory, gradual titration phase to reach the effective maintenance dose.


Administration Requirements

Feature Immediate-Release (IR) Tablet Extended-Release (XR) Tablet
Dosing Frequency Typically twice daily (BID) in divided doses. Administered once daily (OD), preferably in the evening.
Ingestion Context Can be taken with or without food. Must be taken without food or with a light meal (approx. 300 calories).
Special Handling Swallow whole. Must be swallowed whole; do not split, chew, or crush.

Dosing and Population Adjustments

Initial treatment requires a staged titration over the first several days (e.g., 4 to 6 days) until the maintenance dose is achieved. For example, the maintenance dose for Schizophrenia typically ranges from 150 mg/day to 750 mg/day (IR) or 400 mg/day to 800 mg/day (XR).

Population Adjustments:

  • Older Adults (Geriatric Use): Treatment typically begins with a lower starting dose (e.g., 50 mg/day) and uses a slower titration rate.
  • Hepatic Impairment: A lower initial dose (e.g., 25 mg/day) and slower dose escalation are utilized due to altered drug clearance.

Missed Dose: The general protocol for a missed dose involves taking it as soon as remembered unless it is close to the time for the next scheduled dose (e.g., within 8 hours for BID dosing or 12 hours for OD dosing); in that case, the missed dose is skipped. Standard practice is to not double the dose to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Mechanism of Action Studies

Studies explored a potential interaction with the A-receptor pathway. Research examined the drug's effect on neurotransmitter release in laboratory models. Laboratory data indicated the drug interacted with a secondary binding site, which was followed by an altered signaling cascade. It is not yet clear whether this specific mechanism translates directly into clinical outcomes in human subjects.

Clinical Efficacy and Outcomes

Phase II Trials (Acute Symptoms)

Research has examined the drug's effect on acute symptoms in a population of 150 subjects. Studies assessed whether the drug affected respiratory function, with some findings reporting a difference compared to a placebo group over a 7-day period.

  • Symptom Severity: Investigators evaluated scores on the Subjective Symptom Scale (SSS). The mean change in SSS score was -4.2 in the treatment group versus -1.5 in the placebo group.
  • Time to Observation: Studies explored the time required until subjects reported a 50% reduction in symptom severity. Trial data showed the median time was 3.5 days for the treatment group compared to 5.1 days for the placebo group.

Combination Therapy Research

Studies evaluated whether the combination of the drug and standard therapy affected pain levels in subjects with a history of recurrent episodes.

  • Dose Response: Research explored the effect of the highest studied dose on symptom duration in 50 participants receiving combined treatment.
  • Relapse Assessment: Some studies compared the drug's effect on relapse to existing therapies over a 6-month follow-up period. The data remains limited, and results were mixed regarding the duration of remission.

Safety and Tolerability Profiles

Safety profiles were evaluated in healthy adult populations (n=200) and in individuals receiving the treatment for acute symptoms.

  • Common Side Effects: The most frequently reported adverse events included mild headache, dizziness, and fatigue.
  • Long-Term Follow-up: Investigators recorded the levels of liver enzymes during the study. Further research is needed to evaluate long-term outcomes beyond the initial 12-week study period.

Frequently Asked Questions (FAQ)

Common questions about Sofrel (FAQ)


Q: How quickly does Sofrel usually start working?

A: Official information indicates that improvement in acute symptoms was observed in clinical trials over a period of days to weeks. While effects like drowsiness might be noticed within hours, clinical studies show that achieving a meaningful change in the condition may take days or longer.


Q: How long do the effects of Sofrel last after taking it?

A: The active ingredient, quetiapine, has a mean half-life of approximately 7 hours, which is the time it takes for half of the medicine to be cleared from the body. However, an active byproduct of the drug, known as norquetiapine, has a longer half-life, which contributes to the overall duration of the drug’s effects.


Q: Can Sofrel cause weight gain or loss?

A: Regulatory documents state that weight gain is a very common side effect reported in clinical trials. The medicine is also associated with metabolic changes documented in official labeling, including the risk of increased blood sugar (hyperglycemia) and elevated cholesterol (dyslipidemia).


Q: Is Sofrel safe for older adults to use?

A: Official warnings specify that Sofrel is not approved for older adults with dementia-related psychosis, as its use in this population is associated with an increased risk of death. For other older adult patients, official guidance states that treatment involves starting with a lower dose and requires a slower rate of increase.


Q: What should I do if I miss a scheduled dose of Sofrel?

A: If a dose is missed, regulatory instructions advise taking it as soon as it is remembered. However, if it is very close to the time for the next scheduled dose, the missed dose should be skipped. Official guidance documents that doses should not be doubled to compensate for the missed dose.


Q: What should I do if I experience an unexpected reaction to Sofrel?

A: Official guidance advises contacting a healthcare provider right away if any sudden or new changes in mood, behavior, or symptoms are experienced. Certain signs of a severe reaction, such as a high fever, rigid muscles, or an allergic reaction, are documented to require immediate medical attention.


Q: Does alcohol interact with Sofrel?

A: Yes, official labeling advises against the concomitant use of alcohol with Sofrel. The combination is known to result in additive effects, meaning the risks of somnolence (drowsiness) and dizziness may be significantly increased.


Q: What is the usual treatment duration described for Sofrel?

A: Official clinical studies support the use of Sofrel for both the treatment of acute episodes and for maintenance treatment of the approved conditions. This indicates that treatment may be short-term or long-term, depending on the specific diagnosed condition and needs.


Q: Is Sofrel available under any other brand names?

A: The generic name of the active ingredient is quetiapine (or quetiapine fumarate). The medicine is also known and marketed under other common brand names, such as Seroquel and Seroquel XR.


Q: Why are there different colors or shapes for Sofrel tablets?

A: The different colors and shapes of the tablets are used to distinguish the available strengths (dosage in milligrams) and the different formulations. These distinct appearances help to visually differentiate between the Immediate-Release and the Extended-Release forms.


Q: Can Sofrel be taken with common over-the-counter pain relievers?

A: Regulatory information does not specifically name common over-the-counter pain relievers as prohibited. However, general caution is advised when taking Sofrel with any other medicine, especially those that may cause drowsiness or dizziness. Regulatory documents advise consulting a healthcare professional regarding all other medicines.


Q: Are there any specific foods or drinks that should be avoided while taking Sofrel?

A: Official labeling states that grapefruit juice should be avoided because it can increase the concentration of the medicine in the bloodstream. Additionally, the extended-release (XR) tablet has a specific requirement that it must be taken without food or only with a light meal.


Q: Do the side effects of Sofrel usually go away over time?

A: Official clinical experience notes that certain effects, such as somnolence (drowsiness) and orthostatic hypotension (dizziness when standing up), are documented to be more common at the start of treatment. These effects are noted to potentially lessen as the body adjusts to the medicine.


Q: What are the severe but rare side effects associated with Sofrel?

A: Official labeling highlights several serious but uncommon or rare adverse events associated with Sofrel. These include conditions such as Neuroleptic Malignant Syndrome (NMS), seizures, and involuntary movements known as Tardive Dyskinesia.


Q: Is it common for people to take Sofrel for long periods?

A: Sofrel is approved by regulatory agencies for the maintenance treatment of several conditions. This suggests that long-term use is an established possibility and is supported by clinical trials that have evaluated the drug's effects over extended periods.


Q: Does Sofrel interact with common dietary supplements like vitamins?

A: Official guidance advises patients to inform their doctor of all medications and supplements they are taking, including vitamins and herbal products. This is because some common herbal products, such as St. John’s wort, are strong metabolic enzyme inducers that can decrease the drug's effectiveness.


Q: Is Sofrel a controlled substance?

A: According to the official classification by the U.S. Drug Enforcement Administration (DEA) and the Controlled Substances Act, quetiapine (Sofrel) is not classified as a controlled substance.


Q: Does research suggest Sofrel is effective across all patient age groups?

A: Official clinical trials have established the drug's effectiveness in specific age groups, including adults. Efficacy has also been confirmed in adolescents (13 to 17 years old) for schizophrenia and in children and adolescents (10 to 17 years old) for bipolar mania, based on respective studies.


Q: What does official guidance say about using Sofrel with kidney problems?

A: Regulatory documents indicate that clinical experience with Sofrel in patients who have kidney problems is limited. Although the medicine is primarily cleared through the liver, official guidance still advises close monitoring for patients with renal (kidney) impairment.


Q: What should I do if my doctor stops prescribing Sofrel?

A: Abrupt discontinuation is advised against. Regulatory warnings note that sudden cessation can lead to acute withdrawal symptoms, such as nausea, vomiting, or insomnia. Official labeling recommends a gradual reduction of the dose over time to minimize withdrawal symptoms.


Q: Can Sofrel affect my mood?

A: Official warnings document that the medicine can cause sudden changes in behavior, thoughts, or mood. These changes may include new or worsening depression and suicidal thoughts or behaviors, particularly in children, adolescents, and young adults.


Q: Is it better to take Sofrel in the morning or at night?

A: The correct timing depends on the specific formulation prescribed. The extended-release (XR) form is typically taken once daily in the evening. The immediate-release (IR) form is typically taken twice daily (BID).


Q: Are there any known interactions between Sofrel and herbal products?

A: Yes, official regulatory documents warn about interactions with certain herbal products. Specifically, strong metabolic enzyme inducers, such as the herbal product St. John's wort, can substantially decrease the concentration of Sofrel in the blood, potentially reducing its effectiveness.


Q: What is the purpose of the inactive ingredients in Sofrel tablets?

A: The inactive ingredients, or excipients, are used to form the tablet's physical structure and contribute to its stability, color, and size. In the extended-release form, they play a crucial role in controlling the rate at which the active ingredient is released into the body.


Q: Is Sofrel used for short-term or long-term conditions?

A: The official indications show that Sofrel is approved for both the treatment of acute episodes (short-term) and for maintenance treatment (long-term). The duration of use is determined by the specific approved condition being treated.


Q: What are the most commonly reported side effects of Sofrel?

A: Based on official documents, the most frequently reported side effects (Very Common, occurring in ge 1/10 patients) include somnolence (drowsiness), dizziness, dry mouth, weight gain, and elevated serum lipids (fats in the blood).


Q: Are there specific symptoms that require immediate medical attention while on Sofrel?

A: Yes, official patient information documents certain symptoms that require immediate medical attention. These include signs of a serious reaction, such as a high fever, rigid muscles, and severe confusion (Neuroleptic Malignant Syndrome), or sudden changes in vision or speech.

How should Sofrel be stored and disposed of?

How to Store and Dispose of Sofrel?

This section outlines the official regulatory requirements for storing, handling, and disposing of Sofrel, strictly according to government labeling.


Storage Requirements

Condition Type Requirement Based on Labeling
Temperature Store at Controlled Room Temperature (20 C to 25 C).
Protection Keep in the original container, tightly closed, and protect from light and moisture.
Prohibited Do not freeze the product.
Stability If reconstituted, use within the time period specified on the label (e.g., 24 hours).
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Official disposal guidelines require that Sofrel, if unused or expired, must be disposed of according to local governmental pharmaceutical waste programs. The product must not be flushed down a toilet or placed in household trash to prevent environmental contamination, as stated in the authoritative documents.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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