Opipramol

Quick links to important sections

Opipramol

Treatment option:

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 Opipramol

This overview defines the identity and classification of Opipramol, detailing its composition and general purpose while strictly adhering to factual accuracy and excluding all clinical administration, safety, and commercial information.

Property Description
Active ingredient Opipramol dihydrochloride (INN)
Form Oral tablet (e.g., film-coated or sugar-coated)
Pharmacological class Anxiolytic (Anti-Anxiety Agent) and Atypical Antidepressant
Common purpose Relief of nervous tension and generalized anxiety symptoms
Origin Synthetic dibenzazepine derivative

What is Opipramol and What is its Composition?

Opipramol is a synthesized psychotropic drug defined as a single-ingredient medication belonging chemically to the dibenzazepine derivative family. The active ingredient is Opipramol dihydrochloride (INN), a compound typically administered via the oral route in the form of a tablet, such as a film-coated or sugar-coated preparation. Structurally, Opipramol contains a tricyclic core; however, its pharmacological effect is distinct from traditional compounds in this group, primarily due to its unique target profile. This difference involves its sigma-1 receptor (sigma1) activity, setting it apart from classic tricyclic agents. The chemical identity of the medication is established by this synthetic compound, C23H29N3O cdot 2HCl, which is combined with solid excipients necessary for the final pharmaceutical preparation.


What Type of Medicine is Opipramol?

Opipramol is classified primarily as an anxiolytic (anxiety-reducing agent) and is categorized within the larger class of atypical antidepressants. Although chemically related to the Tricyclic Antidepressive Agents (TCA), its main function is an anxiety-modulating agent under code N06AA05. Its uniqueness stems from its minimal impact on the reuptake of monoamines (serotonin, norepinephrine, dopamine), the mechanism targeted by most conventional antidepressants. This profile makes Opipramol suited for supporting patients experiencing anxious-depressive states or somatoform disorders. The medication serves to reduce symptoms of generalized anxiety and emotional tension. It helps to stabilize nervous activity and reduce internal restlessness, a property associated with relieving chronic anxiety symptoms without a primary focus on mood elevation.

What side effects are possible with Opipramol?

Possible side effects and safety information

The officially documented adverse effects of Opipramol are classified by frequency and system-organ class according to regulatory standards, primarily involving the Nervous System, Vascular System, and Gastrointestinal System.

Frequency-Classified Adverse Reactions

The safety profile distinguishes between common and rare occurrences. Reactions classified as Frequently (common) include fatigue, dry mouth, blocked nose, hypotension, and orthostatic dysregulation. Adverse reactions listed as Occasionally (uncommon) may involve dizziness, stupor, weight gain, constipation, and transient increases in liver enzymes. Rare or Very Rare effects include conditions affecting the blood, liver, and nervous system.

Serious Adverse Reactions and Safety Patterns

Specific clinically significant adverse reactions that are documented, generally under the rare or very rare categories, include agranulocytosis, severe liver dysfunction, chronic liver damage, seizures, and certain cardiac conduction disturbances. Safety data notes that frequently reported effects such as fatigue and orthostatic dysregulation are noted as occurring especially at the beginning of the treatment. Conversely, severe liver dysfunction and chronic liver damage are reactions reported after long-term treatment.

Population-Specific Safety and Limitations

The official labeling includes specific safety considerations, such as the note that paresthesia (a tingling or prickling sensation) has been reported especially in elderly patients. The use of Opipramol is restricted by contraindications in individuals presenting with acute intoxication (alcohol/sedatives), acute urinary retention, untreated narrow-angle glaucoma, and pre-existing higher-grade atrioventricular heart blockages. These restrictions delineate the boundaries for safe use as established by regulatory authorities.

Overdose and Emergency Response

Opipramol Overdose and When to Seek Help

Opipramol overdose can lead to severe and potentially life-threatening symptoms, affecting primarily the central nervous system (CNS) and the cardiovascular system. Official regulatory information emphasizes the need for immediate, specialized medical attention upon suspected or known ingestion of excessive amounts.

Documented Manifestations and Severe Outcomes

Symptoms of opipramol intoxication documented in regulatory sources may include:

  • CNS Effects: Drowsiness, confusion, stupor, and potentially deep coma or seizures.
  • Cardiovascular Effects: Tachycardia (rapid heartbeat), cardiac arrhythmias, and low blood pressure (hypotension).

Severe outcomes include life-threatening ventricular arrhythmias, profound cardiovascular collapse (shock), and respiratory depression.

Required Emergency Actions

Immediate Medical Assistance is Required:

If an overdose is suspected or any symptoms of intoxication occur, it is mandatory to inform a doctor or seek emergency medical help immediately. Individuals should be transferred to a hospital setting for specialist care and continuous observation.

Management is supportive and symptomatic, focusing on stabilizing vital functions. Common clinical measures described include continuous cardiac monitoring (ECG), procedures like gastric lavage or administration of activated charcoal to limit absorption, and specific interventions to manage symptoms such as severe hypotension or seizures. No specific antidote for opipramol overdose is listed in official prescribing information.

Overdose risk is increased in elderly patients or individuals with pre-existing heart conditions.

Therapeutic Uses of Opipramol

Opipramol is generally utilized for its anxiolytic and atypical antidepressant profile, focusing on symptomatic support across clinical contexts where emotional distress is a core problem.

The compound is indicated for the treatment of Anxiety Disorders and Psychosomatic Disorders. Its primary role is providing supportive symptomatic relief in situations involving certain distressing symptoms linked to psychological tension.


Key Therapeutic Focus

This medication is commonly used across conditions presenting with recurrent or episodic manifestations of chronic worry and nervous tension, such as Generalized Anxiety Disorder and Somatoform Disorders. It is applied in addressing symptom clusters that include internal restlessness, anxiety-related physical discomfort, and sleep disturbances secondary to heightened physiological activity. Opipramol may assist with managing symptoms that interfere with daily comfort, offering supportive benefit to ease the overall symptom burden and supporting the patient during difficult episodes.

Focus: Pervasive Nervous Tension


Addressing Stress and Function

Opipramol may be considered relevant in contexts marked by increased discomfort or tension where emotional or psychological stress manifests physically. It may assist with maintaining functional stability when symptoms create noticeable physiological strain, supporting the patient during difficult episodes by easing distress and supporting general well-well-being during symptomatic phases.

Eligibility and Restrictions for Use

Who Can and Cannot Use Opipramol?

Eligibility for Opipramol is strictly defined by regulatory documents, which classify populations based on absolute contraindications and conditional use requirements.

Contraindicated Populations (Must Not Use)

Category Contraindication (Example)
Hypersensitivity Known allergy to opipramol or any tablet excipient.
Acute States Acute intoxication (alcohol, hypnotics, etc.); acute delirium.
Cardiovascular Pre-existing high-grade cardiac conduction disturbances.
Obstructive Conditions Untreated narrow-angle glaucoma; acute urinary retention; paralytic ileus.

Restricted and Non-Recommended Use

Age-Related Rules: Use is established in adults (18+). It is not recommended for the pediatric population (under 18 years) due to insufficient data on safety and efficacy. Older adults should use the medicine with caution.

Physiological States: Use during lactation is contraindicated. Use during pregnancy is restricted and permitted only for compelling indications, particularly in the first trimester.

Comorbidities: Patients with liver or kidney diseases require caution and regular monitoring of organ function. Caution is also advised for patients with a history of seizure disorders or certain hereditary metabolic disorders due to excipients.

What should I know about interactions with other medicines?

The official regulatory profile for Opipramol documents specific pharmacokinetic and pharmacodynamic interaction risks that result in formal co-administration restrictions.

Interaction Restrictions and Timing Rules

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is formally contraindicated due to the risk of severe adverse reactions. This prohibition requires a mandatory 14-day separation period; MAOIs must be discontinued for at least two weeks prior to Opipramol initiation, and the same washout period applies when discontinuing Opipramol before starting an MAOI. Additionally, Opipramol treatment is contraindicated for initiation during acute alcohol, sedative, analgesic, or psychotropic intoxications.

Pharmacokinetic Interactions

Opipramol metabolism occurs primarily via the CYP2D6 isoenzyme. Medicines that inhibit this pathway, such as certain antipsychotics (e.g., haloperidol, risperidone) and specific SSRIs (e.g., fluoxetine, fluvoxamine), may increase the plasma concentration of Opipramol. Conversely, enzyme-inducing agents like barbiturates and anticonvulsants are documented to reduce Opipramol exposure, which can potentially attenuate its effect.

Opipramol is also documented to compete for microsomal enzymes and may increase the plasma concentrations of certain co-administered medicinal products, including other tricyclic antidepressants and Class Ic antiarrhythmics.

Pharmacodynamic Interactions

A significant pharmacodynamic interaction is the reinforcement of CNS depressant effects when Opipramol is combined with other CNS depressants. This effect is also noted with alcohol co-ingestion, which can intensify drowsiness. Caution is generally advised for use in patients with liver or kidney diseases.

Mechanism of Action

How Opipramol Works

Sigma-1 Receptor Agonism for Nervous System Pathway Modification

Opipramol's mechanism involves high-affinity agonism at the Sigma-1 receptor (sigma1), which represents a non-monoamine reuptake mechanism. This interaction modulates intracellular calcium signaling and neuronal excitability, which modifies activity in nervous system pathways and influences the central stress response pathways.

H1 Receptor Antagonism for Reduction of Central Arousal

Opipramol additionally exerts an antagonistic (blocking) effect at the central Histamine H1 receptor. By blocking the histaminergic arousal pathway, this mechanism rapidly reduces excessive central vigilance and hyperactivity. This physiological consequence results in a reduction of CNS arousal and alters the perception of internal restlessness.

Dosage and Administration Information

Administration Map: Official Usage Guidelines

Opipramol is an oral medication taken as a tablet, typically available in 50 mg and 100 mg strengths of Opipramol dihydrochloride. Its usage regimen is based on established protocols that define the route, dose, frequency, and duration of the course.


Administration Scope

Feature Standard Protocol
Route of administration Oral (by mouth).
Dosing schedule The total daily dose typically ranges from 50 mg to 300 mg. Treatment is often initiated with lower doses and gradually adjusted.
Timing in relation to meals Can be taken with or without food.
Preparation requirements Tablets are swallowed whole with a sufficient quantity of liquid.
Age-group administration rules Older adults typically require lower doses (e.g., one-third to one-half of the adult dose). Children over six years of age may be prescribed a weight-based dose (e.g., 3 mg/kg body weight).
Missed-dose rules If a dose is missed, the standard approach is to skip the missed dose and continue with the normal schedule; doses are not doubled to compensate.

Frequency and Course Structure

The total daily dose is frequently administered in divided portions up to three times a day. In specific clinical contexts, a single dose, such as 100 mg at bedtime, is a recognized administration pattern. Due to its gradual therapeutic onset, the medication is typically taken regularly for at least two weeks before the full effect is observed. The typical treatment course generally involves an administration period of one to two months, and discontinuation generally involves a gradual tapering process rather than an abrupt stop.

Recent Clinical Evidence

Research evidence / Overview of studies for Opipramol

Research into Opipramol has primarily focused on its evaluation as an anxiolytic agent, with studies examining its application in conditions characterized by heightened nervous tension and anxiety symptoms. The body of research includes controlled trials and scientific reviews that explore how symptoms are measured and how they evolve in observed patient populations.

Evidence for Use in Generalized Anxiety Disorder (GAD)

The structure of research for Generalized Anxiety Disorder includes short-term Randomized Controlled Trials (RCTs) and comparative trials. These trials were primarily used in research exploring how symptoms change over time in adult outpatients diagnosed with the condition. The main focus of research was the evaluation of overall anxiety severity, using standardized measurement scales such as the Hamilton Rating Scale for Anxiety (HAMA).

When research examined symptom intensity and variability, some comparative trials monitored outcomes where the observed measurements for Opipramol were also documented for other agents studied. The certainty of the evidence is low to very low across some measured anxiety outcomes, as determined by formal scientific assessment.

Evidence for Use in Somatoform Disorders

Opipramol was evaluated in the context of somatoform disorders, which are conditions characterized by fluctuating or episodic manifestations of physical symptoms linked to psychological tension. The research structure includes multicenter, placebo-controlled RCTs where researchers primarily assessed changes in the severity of physical (somatic) symptoms using the somatic subscore of the HAMA scale. Trials reported measurements of somatic symptom scores, with research observing the evolution of these scores in the Opipramol group versus the placebo group over the study interval.

What is Still Uncertain in the Research Record

Evidence quality varies across studies, and the certainty of findings remains low for several measured outcomes. Follow-up durations were limited in the primary efficacy studies, meaning that long-term effects are not fully established, and there is insufficient data regarding outcomes beyond the initial treatment phase. Data for certain special groups remain insufficient, meaning there is limited information available from controlled trials regarding its evaluation or use in key special populations.

Frequently Asked Questions (FAQ)

Common questions about Opipramol (FAQ)


Q: What main conditions is Opipramol typically prescribed for?

A: Official regulatory documents indicate that Opipramol is prescribed for the relief of nervous tension and symptoms related to generalized anxiety disorder and somatoform disorders. These indications establish the primary uses of the medication.

Q: What is the concern about taking Opipramol with medications that also cause drowsiness?

A: The official product information warns that co-administration with other Central Nervous System (CNS) depressants, including alcohol, can reinforce their effects. This interaction can reportedly result in increased drowsiness, dizziness, and confusion.

Q: Is Opipramol generally considered appropriate for use in children or adolescents?

A: According to the official safety profile, Opipramol is not generally recommended for the pediatric population (under 18 years) due to insufficient data on safety and efficacy. However, some regulatory texts reference a weight-based dose that may be used for children over six years.

Q: Is Opipramol considered an antidepressant or a medicine primarily for anxiety?

A: Regulatory classification lists Opipramol as both an anxiolytic (anxiety-reducing agent) and an atypical antidepressant. Its main function is widely recognized as anxiety-modulating, confirming its role in treating both anxiety and related emotional states.

Q: What other types of medicines should be mentioned to a healthcare provider when taking Opipramol?

A: Official information indicates Opipramol may compete with other psychotropic drugs and certain cardiovascular agents for metabolism. Patients should ensure they inform their provider about all medicines, particularly those affecting the nervous system or heart function.

Q: Why is Opipramol sometimes described as having a 'biphasic action'?

A: The term 'biphasic action' is used in pharmacological literature to describe a reported effect that occurs in two stages. This generally involves an initial, prompt improvement of symptoms like tension, anxiety, and sleep disturbances, followed by a later improvement in mood.

Q: How long does it usually take to feel an initial effect after starting Opipramol?

A: While the full effect of the medication requires regular dosing for at least two weeks, official information suggests patients may notice an initial improvement in anxiety symptoms within the first one to two weeks of treatment.

Q: Do the calming effects of Opipramol begin before the reported mood effects?

A: Yes, the described biphasic action of Opipramol indicates that the prompt initial improvement is typically seen in tension and anxiety symptoms. The subsequent improvement in mood is generally reported later in the course of treatment.

Q: What is the expected timeframe for Opipramol to reach its full therapeutic effect?

A: The full effect of Opipramol requires regular administration for at least two weeks before it can be observed. Some official sources note that the complete observation of the effect may take up to four weeks.

Q: Is Opipramol generally a medicine meant for short-term or long-term management?

A: Although a typical treatment course often advises use for one to two months, research evidence shows that primary efficacy studies had limited follow-up durations. This means that definitive information on the safety and effects of long-term use is not fully established.

Q: Does Opipramol commonly affect a person's ability to drive or operate machinery?

A: Official regulatory warnings advise that Opipramol can cause side effects such as drowsiness, dizziness, and blurred vision. These effects may impair a person’s ability to drive a vehicle or operate heavy machinery.

Q: Can Opipramol affect energy levels or cause noticeable fatigue?

A: According to the official safety profile, fatigue is classified as a frequently reported adverse reaction. This effect is often noted as occurring especially at the beginning of treatment.

Q: Is there information about Opipramol causing changes in vision or blurred sight?

A: Yes, official safety data indicates that blurred vision is listed as a potential side effect associated with Opipramol use.

Q: Does taking Opipramol often lead to nasal congestion or a stuffy nose?

A: Yes, the official safety profile classifies nasal congestion, often described as a blocked or stuffy nose, as a frequently reported adverse reaction.

Q: Is it possible to take Opipramol concurrently with other anxiety medications?

A: Official information notes that Opipramol is specifically contraindicated (must not be used) for initiation during acute intoxication involving sedatives. Outside of contraindications, concurrent use is noted as requiring caution in official documents due to the potential for reinforced Central Nervous System depressant effects.

Q: Does Opipramol interact with common blood pressure medications?

A: Regulatory warnings note that Opipramol is known to interact with certain beta-blockers. Additionally, its use is associated with effects like hypotension (low blood pressure) and orthostatic dysregulation (a form of dizziness upon standing).

Q: Is it normal to feel restlessness or agitation if Opipramol is being discontinued?

A: Official product information states that the abrupt discontinuation of the medicine may increase the risk of adverse effects. Symptoms reported when stopping the medicine too quickly may include restlessness, tremor, or agitation.

Q: Does research suggest a specific clinical approach for gradually stopping Opipramol?

A: Regulatory guidance advises against stopping the medication quickly and suggests a gradual dose reduction to minimize the potential for adverse effects.

Q: What does research indicate about Opipramol's effectiveness compared to placebo?

A: Research has included randomized controlled trials for conditions like generalized anxiety disorder and somatoform disorders. These studies evaluated how anxiety and somatic symptoms change over time in patients receiving Opipramol versus those receiving placebo.

Q: Has Opipramol been studied for conditions other than generalized anxiety disorder?

A: Yes. Official research overviews indicate that Opipramol has been examined for use in somatoform disorders. Furthermore, studies have also explored its application in other areas, such as controlled trials for the management of migraine.

Q: Does Opipramol affect the brain's serotonin or norepinephrine in the same way as other SSRI/SNRI antidepressants?

A: No, Opipramol's pharmacological effect is distinct from most conventional antidepressants. Its action does not involve the reuptake inhibition of serotonin or norepinephrine, acting instead as a non-monoamine reuptake mechanism.

Q: What is the information regarding Opipramol and its interaction with antipsychotic medicines?

A: Official documents indicate that Opipramol is metabolized by the CYP2D6 enzyme. Medicines that inhibit this enzyme pathway, such as certain antipsychotics, may potentially increase the plasma concentration of Opipramol.

Q: What are the common symptoms people report when reducing their Opipramol use too quickly?

A: To avoid potential issues, regulatory documents advise against stopping the medicine suddenly. Symptoms reported when reducing the dose too quickly may include effects related to the nervous system, such as restlessness, agitation, or tremor.

How should Opipramol be stored and disposed of?

Storage Requirements

Opipramol tablets must be stored according to official regulatory labeling to ensure product stability and quality. The labeled storage conditions for the active ingredient, Opipramol dihydrochloride, are:

Requirement Category Official Regulatory Statement
Temperature Store at a temperature not exceeding 30 C
Protection Must be protected from light and moisture
Packaging Store the medicinal product in the original packaging
Child Safety Keep the medicine out of the sight and reach of children

Disposal Instructions

Disposal must adhere to local pharmaceutical waste handling guidelines. It is officially mandated that unused or expired Opipramol tablets must not be thrown into household garbage or wastewater due to the potential for environmental contamination. Disposal must follow local regulatory requirements, which typically involves returning the medicine to a pharmacy or an authorized drug take-back program.

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

Equivalent of Opipramol found in:

A-Z Index: