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Surmontil 100

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Surmontil 100

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Method of action: Psychoanaleptics

Treatment option: Depression

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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.

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Overview of Surmontil 100

Property Description
Active ingredient Trimipramine
Form Hard Capsule
Pharmacological class Tricyclic Antidepressant (TCA)
Common use Modulation of mood and anxiety/agitation
Origin Synthetic, Dibenzazepine derivative

The medication Surmontil 100 is an oral pharmaceutical preparation containing the active ingredient Trimipramine, which is used to help restore emotional balance. It is classified as a Tricyclic Antidepressant (TCA) and is a synthetic compound belonging to the dibenzazepine chemical family. The formulation is consistently presented as a hard capsule, and the "100" signifies a specific dosage strength.


What Type of Medicine is Surmontil 100?

Surmontil 100 is a prescription-only medication whose core substance is Trimipramine, officially designated as an atypical Tricyclic Antidepressant (TCA). This class of agents is used to influence the psychological and physical symptoms associated with mood conditions. Its clinical application relates to its distinguishing receptor affinity profile. The drug is a single-entity synthetic compound, a dibenzazepine derivative, utilized for its capacity to stabilize mood. This positioning makes it a recognized option when the patient's condition includes significant agitation or difficulty sleeping alongside low mood.


Composition and General Purpose of Trimipramine

The medication is composed of the active substance, Trimipramine (typically in the form of the maleate salt), encapsulated within an inert matrix of pharmaceutical excipients suitable for oral administration. While most classical TCAs focus predominantly on blocking the reuptake of neurotransmitters like norepinephrine and serotonin, Trimipramine's unique mechanism involves potent antagonism of certain receptors, notably the H1 histamine receptors. This specific action is responsible for its marked sedative properties, a feature that differentiates it from many standard TCAs and newer classes. This contributes to its general therapeutic purpose: providing relief from low mood and easing associated symptoms like intense anxiety or agitation, thus promoting overall emotional stability.

Regulatory References

  1. Trimipramine: MedlinePlus Drug Information
  2. Tricyclic Antidepressants - StatPearls - NCBI/NIH
  3. Trimipramine - LiverTox - NCBI/NIH
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What side effects are possible with Surmontil 100?

Possible Side Effects and Safety Information: Surmontil 100 (Trimipramine Maleate)

Serious and Clinically Significant Adverse Reactions

Suicidality Risk (Boxed Warning): Antidepressants, including Surmontil, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (up to age 24) in short-term studies. Surmontil is not approved for pediatric use, and all patients starting therapy must be closely monitored for worsening depression and the emergence of unusual changes in behavior or suicidality, especially during the initial months of treatment or following dose changes.

Cardiovascular Risks: Use is contraindicated during the acute recovery period following a myocardial infarction. Extreme caution is necessary in patients with existing cardiovascular disease due to the potential for arrhythmias, heart block, conduction defects, and QT prolongation, which may lead to a rare but dangerous heart rhythm called Torsade de Pointes.

Serotonin Syndrome: A potentially life-threatening condition may occur, particularly when Surmontil is taken with other serotonergic drugs (e.g., triptans, SSRIs) or with Monoamine Oxidase Inhibitors (MAOIs), with which it is strictly contraindicated.

Common and Other Safety Concerns

Adverse reactions commonly associated with Surmontil’s anticholinergic properties include dry mouth, constipation, blurred vision, and urinary retention. Other frequent effects involve the central nervous system, such as drowsiness, dizziness, and tremor.

Population-Specific Warnings: Elderly patients are more sensitive to adverse effects, including confusion and postural hypotension. Due to the risk of mydriasis (pupil dilation), caution is advised in patients with narrow-angle glaucoma as it may precipitate an angle-closure attack. Treatment may also induce hypomania or mania in susceptible individuals.

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Overdose and Emergency Response

A Trimipramine (Surmontil 100) overdose is described in regulatory documents as a severe, multi-system toxic event carrying the potential for a fatal outcome and requiring immediate intervention. The primary concerns noted in official labeling relate to life-threatening effects on the cardiovascular and central nervous systems.

Documented Clinical Manifestations

Symptoms officially documented include severe CNS effects such as coma, seizures, confusion, agitation, and profound drowsiness. Anticholinergic manifestations are also noted, encompassing signs like dilated pupils, fever, and the potential for urinary retention.

Life-Threatening Outcomes and Emergency Action

The most severe documented outcomes are related to cardiac toxicity, presenting as irregular heartbeats (dysrhythmias), severe low blood pressure (hypotension), and significant cardiac conduction abnormalities like QRS complex widening. Consequently, official guidance strictly mandates that immediate emergency medical attention must be sought for any suspected overdose exposure, regardless of symptom severity, due to the risk of delayed, serious complications.

Required Supportive Measures

Management is described as symptomatic and supportive treatment within a hospital setting. This includes continuous patient monitoring, specifically continuous ECG monitoring, and the application of procedures such as activated charcoal or administering agents like sodium bicarbonate to manage severe cardiac effects, as documented in authoritative regulatory literature.

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Therapeutic Uses of Surmontil 100

Quick Facts

  • Primary Use: Management of depressive illness.
  • Specific Benefits: May assist with symptoms of depression, particularly where anxiety, agitation, or sleep disturbance are present.

Surmontil (trimipramine) is an established prescription medication used in the management of depressive illness. Its primary therapeutic role is to provide relief of symptoms associated with depression. This medication is often used when a patient presents with concurrent symptoms such as anxiety, agitation, or sleep disturbance, as it includes a component that may assist with sedation, which can address sleep-related challenges.

The medication has been observed to be useful across a range of depressive states. Its application in this context relates to its ability to contribute to symptom reduction and support overall mental well-being in patients diagnosed with this condition.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Surmontil 100

The eligibility for Surmontil (Trimipramine) is strictly defined by regulatory documents, distinguishing between populations permitted use, those for whom use is contraindicated, and those requiring caution.

Absolute Contraindications

Surmontil must not be used by patients with a known hypersensitivity to trimipramine or other dibenzazepine compounds. Use is also contraindicated for patients who are currently taking, or have recently taken within the last 14 days, a Monoamine Oxidase Inhibitor (MAOI). The medicine is also prohibited during the acute recovery period after a myocardial infarction (heart attack).


Population and Condition Restrictions

Population/Condition Eligibility Status (Regulatory Basis)
Age (Pediatric) Not approved for use. Safety and effectiveness have not been established in children and adolescents.
Age (Older Adults ge 65) Permitted, but official documentation advises caution due to potential sensitivity.
Pregnancy/Lactation Safety not established during pregnancy (Category C). Discontinue nursing or the drug is advised during lactation.
Cardiovascular Disease Use requires extreme caution due to the risk of conduction defects or arrhythmias.
Organ Impairment Caution is advised for patients with impaired liver function or renal insufficiency.

This eligibility structure confines use to adult patients without contraindications and mandates special consideration or prohibition for groups where safety is unestablished or where underlying health risks are heightened.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Co-administration of Surmontil (trimipramine) with certain substances is restricted by regulatory authorities due to the potential for significant interaction outcomes. All information reflects officially documented constraints from regulatory prescribing information.

Formal Restrictions and Contraindications

The use of Monoamine Oxidase Inhibitors (MAOIs), including the MAOI-like drugs linezolid and intravenous methylene blue, is formally contraindicated with Surmontil. A mandatory separation period requires that a minimum of 14 days must pass between discontinuing an MAOI and starting Surmontil, or vice-versa.

Pharmacodynamic and Metabolic Interactions

Co-use with other serotonergic agents (such as SSRIs, SNRIs, and Triptans) is associated with the risk of Serotonin Syndrome due to additive effects. Additive effects also occur with Central Nervous System (CNS) depressants, including alcohol, leading to exaggerated CNS depression and psychomotor impairment. Restriction also applies to co-administration with systemic sympathomimetic agents due to the potential for increased potency, which can lead to hypertension or cardiac arrhythmias.

Pharmacokinetic interactions involve substances that alter the metabolism of trimipramine. Drugs that inhibit the CYP2D6 enzyme may increase the plasma concentration of Surmontil. Specific medicines like cimetidine are documented to alter trimipramine clearance, and barbiturates may increase the rate of trimipramine metabolism.

Population and Substance Considerations

In elderly individuals, circumstances such as hepatic or renal impairment must be considered, as slower clearance of trimipramine may influence its effects. The herbal product St. John’s Wort is classified as a serotonergic agent that contributes to the risk of Serotonin Syndrome when combined with this medicine.

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Mechanism of Action

How Surmontil 100 Works

Surmontil 100 (Trimipramine) functions primarily by inhibiting the neuronal reuptake of two key monoamine neurotransmitters: norepinephrine and serotonin (5-HT) in the central nervous system. The drug acts as a non-selective inhibitor by blocking the function of the presynaptic norepinephrine transporter (NET) and the serotonin transporter (SERT). This pharmacodynamic action results in an immediate increase in the synaptic concentrations of both norepinephrine and serotonin within the synaptic cleft. The elevated presence of these neurotransmitters then modulates the activity of postsynaptic receptors.

The tricyclic chemical structure of Surmontil 100 also contributes to its overall profile by allowing it to interact with several other targets. It exhibits significant antagonistic activity at both histamine H1 receptors and muscarinic acetylcholine receptors, directly blocking the signaling pathways mediated by these receptors. This receptor binding constitutes a secondary, non-monoaminergic component of the drug's mechanism.

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Dosage and Administration Information

Surmontil (trimipramine) capsules are taken orally (by mouth). The medication is typically administered once daily, often at bedtime, or in divided doses, as directed by a healthcare professional. Taking the entire daily dose at bedtime may be recommended to help manage potential drowsiness.

Official Dosing and Titration

Treatment begins with a low initial dose that is gradually increased over several weeks—a process known as dose titration—to find the lowest effective amount for the patient. The prescribed dose varies based on the patient's setting (outpatient vs. inpatient) and age.

Patient Group Initial Daily Dose Typical Maintenance Dose Maximum Daily Dose
Adult Outpatients 75 mg 50–150 mg 200 mg
Adult Inpatients 100 mg 200 mg 300 mg
Adolescents 50 mg Up to 100 mg 100 mg
Elderly 50 mg Up to 100 mg 100 mg

For elderly patients, treatment should begin with a lower initial dose, and any dose adjustments must be cautious. The dose should generally not exceed 100 mg per day in this age group.

Duration and Discontinuation

Therapy must be continued for a specified duration to help prevent a relapse; maintenance treatment is typically recommended for at least three months. You must not stop taking this medicine abruptly. When discontinuing, the dose must be gradually reduced under the guidance of a physician to avoid potential discomfort.

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Recent Clinical Evidence

Surmontil 100: Recent Clinical Evidence

Surmontil (trimipramine) is a tricyclic antidepressant (TCA) that has been evaluated in various clinical studies, primarily for the relief of depression symptoms. Research indicates that the drug's effectiveness is generally comparable to that of other older TCAs, such as imipramine, in trials involving depressed patients, including those who are hospitalized.

Measurements and Outcomes Studied

Clinical trials have investigated trimipramine's effects in two main areas: mood and sleep patterns. Due to its significant sedative properties, the drug has been specifically studied for depression accompanied by anxiety, agitation, or sleep disturbance. Evidence suggests that, unlike many other hypnotics, trimipramine may not suppress REM sleep (Rapid Eye Movement sleep), which is a unique characteristic noted in some studies.

Primary research endpoints for efficacy typically centered on validated rating scales for depression, with initial effects sometimes observed within 1 to 2 weeks of treatment initiation, and continued improvements noted over 4 to 6 weeks.

Safety and Tolerability Profile

Safety studies, including long-term assessments, have documented the drug's profile, which is characteristic of tertiary amine TCAs. Common adverse events observed in research include anticholinergic effects such as dry mouth, constipation, and blurred vision, as well as sedation and weight gain.

Research has also specifically addressed the drug's cardiovascular safety, particularly in patients with pre-existing mild heart disease. Some studies suggest that trimipramine may have a relatively favorable cardiotoxicity profile compared to certain other TCAs. However, like all antidepressants, clinical trials include a Boxed Warning regarding the increased risk of suicidal thoughts and behavior in children, adolescents, and young adults (up to age 24) compared to placebo.

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Frequently Asked Questions (FAQ)

Common questions about Surmontil 100 (FAQ)

Q: Does Surmontil cause weight gain for most people?

Regulatory documents indicate that weight gain is a commonly reported adverse event that was observed during clinical trials. However, official product information does not uniformly specify the exact frequency or likelihood of this effect across all patients.


Q: How long does it usually take to feel the effect of Surmontil on mood?

The onset of the clinical effect on mood is often noted within 1 to 2 weeks after beginning therapy. Official studies and product information indicate that continued and more pronounced improvements typically occur over a period of 4 to 6 weeks.


Q: What is 'anticholinergic effect,' and why is it common with Surmontil?

An anticholinergic effect refers to the blockade of certain chemical signals in the body. This specific action is prominent with Surmontil due to its mechanism, which can lead to commonly reported effects such as dry mouth, constipation, or blurred vision.


Q: Can Surmontil affect the way other non-prescription medications work?

Yes, official drug information indicates that Surmontil can interact with certain substances. Regulatory information states co-use with Central Nervous System (CNS) depressants and certain herbal products may alter the characteristics of the medicine's action.


Q: Is the tiredness felt when starting Surmontil expected to go away?

Drowsiness is a frequently reported effect of the medication, which has known sedative properties. While therapeutic benefit on mood is typically noted over four to six weeks, official documents do not uniformly specify the expected duration or resolution for all side effects.


Q: Does Surmontil affect sleep or cause drowsiness during the day?

The drug is recognized for its pronounced sedative action and is often used for depression when accompanied by sleep disturbance. This sedative property may be associated with feeling drowsy during the daytime hours.


Q: Is Surmontil a habit-forming or addictive medication?

Regulatory drug status information notes that Surmontil (trimipramine) is not classified as a controlled substance. The medication has no known risk of drug abuse or physical dependence according to official sources.


Q: Are there any common foods or drinks that should be avoided when taking Surmontil?

Regulatory documents specifically note that the drug interacts with alcohol, which is classified as a CNS depressant. However, no specific restrictions are listed for common foods.


Q: What are the possible risks of taking Surmontil while pregnant or breastfeeding?

Official documents classify the drug as Pregnancy Category C. This indicates that animal studies showed potential adverse effects on the fetus, and there are no adequate human studies, but potential benefits may warrant its use despite the potential risks. Caution is advised during lactation.


Q: Can Surmontil cause tremors or uncontrollable shaking?

The clinical effects listed in regulatory documents include tremor (shaking) as a reported adverse event. The product label does not specifically use the term 'uncontrollable shaking' to describe this effect.


Q: Is a sudden increase in energy or restlessness a reason to be concerned when starting Surmontil?

Regulatory patient information indicates that the emergence of symptoms such as agitation, restlessness, or a big increase in energy should be reported immediately, especially during the initial phase of treatment. These changes may indicate a worsening condition or unusual changes in behavior or suicidality.


Q: Does Surmontil change a person's personality?

Regulatory documents instruct patients, families, and caregivers to monitor for unusual changes in behavior or emergent symptoms, especially when starting the medication or following dose changes. This is part of the ongoing monitoring for unusual changes in behavior.


Q: Is Surmontil only used for severe depression?

The medication is approved by regulatory authorities for the treatment of symptoms associated with Major Depressive Disorder. Official product information does not restrict its approved use to only severe cases.


Q: What kind of monitoring is recommended for people taking Surmontil?

Monitoring requirements include close observation for worsening depression or unusual behavioral changes, especially during initial therapy. ECG monitoring (to check heart function) may also be required for certain patients due to potential cardiovascular risks.


Q: What happens if a person forgets to take a dose of Surmontil?

Official patient information generally advises to take the missed dose as soon as remembered unless it is nearly time for the next dose. If so, the missed dose should be skipped, and doubling the dose is not recommended.


Q: Does Surmontil have any known interactions with herbal supplements?

Regulatory documents specifically mention the herbal product St. John's Wort. This supplement is classified as a serotonergic agent that contributes to the risk of Serotonin Syndrome when combined with this medicine.


Q: What is the evidence supporting the use of Surmontil in children or teenagers?

The safety and effectiveness of the medication have not been established in children and adolescents. Due to the lack of evidence, the drug is not approved for use in the pediatric population.


Q: Can Surmontil affect a person's sex drive or sexual function?

Adverse events reported in regulatory documentation include decreased sex drive and other effects on sexual function. These effects may include difficulty having an orgasm or issues such as impotence.


Q: What happens in the body that causes the mood-lifting effect of Surmontil?

The drug's mechanism involves blocking the reuptake of the neurotransmitters norepinephrine and serotonin. This action immediately increases their concentration in the spaces between nerve cells, leading to a modulated effect.


Q: Can Surmontil cause ringing in the ears (tinnitus)?

Regulatory documentation lists ringing in the ears (clinically known as tinnitus) as a reported side effect associated with the medication.


Q: Is Surmontil considered safe for people who have a history of seizures or epilepsy?

Official warnings state that use of the medication requires caution in patients with a history of seizures or epilepsy. Official information indicates the drug could worsen these conditions.


Q: Do official studies suggest Surmontil helps people stay better and avoid relapse?

Official documents note that there is substantial evidence from clinical maintenance trials in adults that the use of antidepressants can help delay the recurrence of depression.


Q: What kind of mental changes should a caregiver look for in a person starting Surmontil?

Caregivers are advised to monitor for specific emergent symptoms, including agitation, irritability, unusual changes in behavior, and the emergence of suicidality, especially during the first few months of treatment.


Q: Can Surmontil cause memory problems or confusion?

Regulatory documents list confusion as a possible adverse effect. This effect may be more noticeable in older adults, and official information advises monitoring for unusual thoughts.


Q: Do genetic factors influence how a person responds to Surmontil?

Yes, official information notes that the drug is metabolized by the CYP2D6 enzyme. Individuals with genetic variations in the function of this enzyme may have altered concentrations of the drug in their blood.


Q: What is the risk of having a manic episode while taking Surmontil?

Regulatory documents warn that treating a major depressive episode with an antidepressant may increase the likelihood of precipitating a mixed or manic episode in patients who are at risk for bipolar disorder.


Q: Can Surmontil cause changes in blood pressure or heart rate?

The medication is associated with cardiovascular risks, including the potential for arrhythmias (irregular heartbeats). Adverse reactions can include tachycardia (increased heart rate) and hypotension (decreased blood pressure).


Q: Do people typically take Surmontil for the rest of their life?

The duration of therapy is determined by a healthcare provider. Maintenance treatment to help prevent a relapse is typically recommended for at least three months after the initial treatment period.


Q: Is there a link between Surmontil and difficulty urinating?

Reported adverse reactions listed in regulatory documents include both urinary retention (inability to empty the bladder) and difficulty urinating.

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How should Surmontil 100 be stored and disposed of?

Storage & disposal scope

Requirement Official Regulatory Statement
Labeled storage temperature Store at Controlled Room Temperature (CRT), 20 C to 25 C (68 F to 77 F).
Light/moisture protection Protect from direct light, moisture, and heat [Trimipramine (oral route) - Side effects & dosage - Mayo Clinic].
Handling requirements Must be kept from freezing and stored in a tightly closed container [Trimipramine (oral route) - Side effects & dosage - Mayo Clinic].
Disposal instructions Dispose of unused product according to local requirements; do not dispose of via wastewater or general household waste [Trimipramine 25mg Tablets - Summary of Product Characteristics (SmPC) - (emc) 7188].
Child-protection storage Must be stored out of the reach and sight of children [Trimipramine (oral route) - Side effects & dosage - Mayo Clinic].

Storage/disposal classifications (high-level)

Classification Type Official Regulatory Classification
Storage condition type Controlled Room Temperature / Protection from Light and Moisture
Regulatory basis FDA / NIH DailyMed, EMA / SmPC
Storage-context constraints Keep from freezing; Keep away from heat; Tightly closed container

Resulting storage & disposal structure

Official regulatory documents mandate that Surmontil 100 capsules be stored at Controlled Room Temperature, protecting them from heat, freezing, moisture, and direct light. Stability depends on maintaining these conditions until the expiration date. The product must be secured in a tightly closed container and kept out of the reach of children. Disposal of unused or expired medication must follow specific local regulations and is prohibited from being placed in household waste or flushed into wastewater.

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

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