Diazepam Labesfal

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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 Diazepam Labesfal

What is Diazepam Labesfal? (Overview)

Property Description
Active Ingredient Diazepam
Form Tablets, oral solution, or solution for injection (varies by product line)
Pharmacological Class Benzodiazepine; Central Nervous System (CNS) Depressant
Common Use Treating anxiety, muscle spasms, and seizures
Regulatory Status Schedule IV Controlled Substance (in many jurisdictions)

Diazepam Labesfal is a brand-specific pharmaceutical formulation containing the active ingredient diazepam. Diazepam belongs to the benzodiazepine class of medicines, which are clinically recognized for their ability to exert calming, muscle-relaxing, and anti-seizure effects on the central nervous system (CNS).

The drug’s importance is underscored by its inclusion on the World Health Organization Model List of Essential Medicines. This indicates that the compound is internationally accepted as a core, high-efficacy component required for a basic healthcare system.

Diazepam is structurally defined by its C16H13ClN2O molecular formula and its proven ability to enhance the action of the inhibitory neurotransmitter GABA. The compound’s efficacy in managing conditions such as acute anxiety or severe muscle spasm is recognized alongside its therapeutic actions, which include sedative, anxiolytic, and anticonvulsant properties.

The specific brand name "Diazepam Labesfal" differentiates this product as manufactured by Labesfal - Laboratórios Almiro, S.A. This formulation is primarily distributed within the European Union market, subject to strict oversight and detailed product specifications.

Regulatory References

  1. National Institutes of Health (NIH)
  2. European Medicines Agency (EMA)

What side effects are possible with Diazepam Labesfal?

Possible side effects and safety information

The safety profile for this medicine is characterized by adverse reactions that are classified by regulatory authorities based on frequency and affected system-organ class. The most frequently documented effects often involve the Central Nervous System (CNS).

Category Regulatory Safety Classification
Common Effects Drowsiness, fatigue, and ataxia (loss of coordination) are frequently observed, particularly at the initiation of therapy.
System Affected Adverse reactions are classified across various systems, including Nervous system disorders, Psychiatric disorders, Musculoskeletal, Vascular (e.g., hypotension), and Hepatobiliary (e.g., jaundice).

Serious adverse reactions are specifically addressed in regulatory labeling. The use of the active substance, diazepam, carries a documented risk of physical and psychological dependence, particularly with prolonged use. Abrupt cessation following chronic use may precipitate a severe withdrawal syndrome. A significant safety concern highlighted in official documents is the potential for respiratory depression, especially when used in combination with other CNS depressants such as opioids.

Safety Constraints and Special Populations

Official prescribing information defines specific safety limitations and constraints on use. The medicine is contraindicated in conditions such as severe respiratory insufficiency, severe hepatic insufficiency, myasthenia gravis, and sleep apnea syndrome.

Regulatory documents also detail population-specific safety considerations. Older adults face an increased risk of serious sedation and ataxia, which can increase the risk of falls due to altered metabolism and clearance. Use during late pregnancy is associated with risks of neonatal sedation or withdrawal symptoms after birth.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Diazepam Labesfal is primarily characterized by escalating Central Nervous System (CNS) depression. Documented initial manifestations include drowsiness, mental confusion, impaired reflexes, and uncoordinated movement (ataxia). The official regulatory profile notes that overdose can progress from profound sedation to severe, life-threatening outcomes.

The most serious documented outcomes are respiratory depression, hypotension, coma, and death. This risk is significantly heightened when the drug is used concurrently with other CNS depressants, such as opioids. Immediate medical attention is required if severe symptoms are noted. Patients and caregivers must contact emergency services or a poison control center right away for signs of slow or shallow breathing or profound difficulty staying awake.

Management is symptomatic and supportive, focusing on maintaining vital functions. Supportive measures include monitoring blood pressure and breathing, and providing mechanical ventilation if necessary. Elderly and very ill patients are noted to be at increased risk for the most serious complications, including apnea or cardiac arrest. The antagonist Flumazenil is a documented agent for reversal, but its administration is associated with the explicit, documented risk of precipitating seizures.

Therapeutic Uses of Diazepam Labesfal

What Diazepam Labesfal Treats: Main Uses and Benefits

This medication is applied across domains where additional symptomatic support is needed in contexts involving acute or disruptive symptom patterns. It is used across conditions presenting with acute episodes, including severe, disabling anxiety states, acute alcohol withdrawal syndrome, skeletal muscle spasms, and plays a role in managing acute repetitive seizure episodes.

Diazepam Labesfal generally provides anxiolytic support that helps ease the overall symptom burden during challenging, short-term periods. The medication is applicable within clinical settings that involve acute or unstable symptom patterns, and is commonly used to help provide symptomatic relief during episodes of sudden symptom escalation.

It offers a myorelaxant benefit that supports the easing of pronounced physical manifestations, contributing to comfort during symptomatic periods. In acute situations, it may assist with maintaining a sense of stability, helping patients cope more steadily with difficult manifestations.


Quick Fact: Relief for Acute Tension This medication is often used when symptoms intensify, providing supportive relief for symptoms related to physical discomfort and heightened physiological activity, such as muscle spasticity or severe apprehension.

Eligibility and Restrictions for Use

Who Can and Cannot Use Diazepam Labesfal?

Population eligibility for Diazepam Labesfal is strictly defined by regulatory documents, distinguishing between approved use, contraindications, and restricted use.


Official Contraindications

Use of this medicine is prohibited in patients with a formal diagnosis of Myasthenia Gravis, severe hepatic insufficiency (liver failure), severe respiratory insufficiency, Sleep Apnoea Syndrome, or Acute Narrow-Angle Glaucoma. The drug is also contraindicated for pediatric patients under 6 months of age (oral forms) and anyone with a known hypersensitivity to diazepam or other benzodiazepines.


Populations Requiring Restricted Use

Population Group Regulatory Restriction Context
Older Adults (Elderly) Requires a reduced dose due to increased physiological sensitivity and risk of accumulation.
Pregnancy/Lactation Not recommended due to documented risks, especially during the first and third trimesters of pregnancy.
Impaired Organ Function Requires caution and a lower dose in cases of Chronic Respiratory Insufficiency or Mild to Moderate Hepatic Impairment.
Substance Abuse History Must be used with extreme caution due to risk of dependence (generally avoided outside of acute withdrawal).

Standard eligibility is limited to Adults for the officially documented short-term, severe indications, provided no specific contraindication is present. Use in children over 6 months is allowed only for compelling medical reasons.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for diazepam establishes critical constraints across drug–drug and drug–substance combinations. The interaction structure is defined by two primary categories: pharmacodynamic effects and pharmacokinetic clearance.

Pharmacodynamic Interaction Constraints

The primary concern involves the augmentation of Central Nervous System (CNS) Depression when combined with other depressants. The co-administration with opioids is reserved under a regulatory warning due to the risk of profound sedation and respiratory depression. The simultaneous ingestion of alcohol is formally contraindicated, leading to enhanced CNS depressant effects.

Pharmacokinetic Clearance Profile

Diazepam is metabolized by the hepatic isoenzymes CYP2C19 and CYP3A4. Interactions are documented for:

  • Agents that Decrease Elimination: Substances that inhibit these enzymes, such as Cimetidine, certain Antidepressants (e.g., Fluoxetine), and Antifungals (e.g., Ketoconazole), are officially noted as increasing systemic exposure.
  • Agents that Increase Elimination: Inducers like Rifampin and certain Anticonvulsants (e.g., Phenytoin) can increase the elimination rate.

Non-Drug and Population Notes

The regulatory profile restricts the consumption of Grapefruit Juice, which is documented to increase the drug's exposure. Co-administration with herbal products for anxiety (e.g., Valerian) can increase drowsiness. Furthermore, Severe Hepatic Insufficiency is a contraindication, and elderly patients require adjustment due to officially noted reductions in clearance.

Mechanism of Action

Diazepam Labesfal operates primarily within the central nervous system as a positive allosteric modulator of the GABA A receptor.

This target is a ligand-gated ionotropic chloride channel, which mediates fast inhibitory neurotransmission. Diazepam binds to a specific allosteric site located at the interface of the alpha and gamma2 subunits, particularly in receptors containing alpha1, alpha2, alpha3, or alpha5 subunits. Its binding does not directly activate the receptor; instead, it induces a conformational change that increases the apparent affinity of the receptor for the endogenous inhibitory neurotransmitter, gamma-aminobutyric acid (GABA).

This allosteric enhancement leads to an increase in the frequency of chloride ( Cl^-) channel opening when GABA is bound. The resultant greater influx of Cl^- ions causes neuronal hyperpolarization, making the post-synaptic neuron less responsive to excitatory stimuli. This increased inhibitory signaling results in a widespread dampening of neural circuit excitability throughout the CNS.

Dosage and Administration Information

How to Use Diazepam Labesfal

This section outlines the administration methods and dosing principles for the medicine.

Routes of Administration and Forms

Diazepam Labesfal is used via several routes depending on the clinical context and urgency. The primary routes include Oral (PO), available as tablets or oral solution for daily use, and Parenteral (Intravenous or Intramuscular injection) for acute scenarios, such as the initial management of Status Epilepticus. Specialized forms, such as rectal solutions and intranasal sprays, are designated for the intermittent treatment of acute repetitive seizure episodes.


Dosing and Frequency Principles

Administration Type Standard Adult Dosage Range Frequency / Duration Note
Oral (Anxiety/Spasm) 2 mg to 10 mg per dose Typically 2 to 4 times a day, in divided doses.
IV (Acute Use) 5 mg to 10 mg May be repeated every 10–15 minutes, up to a cumulative maximum of 30 mg in the initial treatment period.

Oral tablets may be taken with or without food. When administering the intravenous solution, it must be injected slowly, at a rate generally not exceeding 5 mg per minute, to ensure proper procedural control.


Course Length and Adjustments

Treatment duration for conditions like anxiety and muscle spasm is intended to be for the shortest possible period, generally not exceeding four weeks. Upon discontinuation, the dose must be gradually reduced; abrupt cessation is advised against to prevent withdrawal phenomena. For older adults and patients with hepatic impairment, a reduced starting dose (often half the adult dose) is indicated due to altered drug clearance.

Recent Clinical Evidence

Research evidence / Overview of Studies for Diazepam Labesfal


Evidence for Use in Severe, Disabling Anxiety States

Diazepam Labesfal was studied for its relevance in trials assessing short-term or episodic symptom patterns of severe anxiety. Researchers primarily used short-term Randomized Controlled Trials (RCTs) and meta-analyses to evaluate how measures of severe anxiety symptoms change over time. Findings describe patterns observed in the studies where measurable changes in standardized scores were observed in study participants during the initial, short-term treatment phases. Research describes the observed calming and sedative patterns in the observed populations.

However, follow-up durations were limited in this area of research, meaning that the data for long-term outcomes are not fully established. Evidence is limited regarding research exploring conditions characterized by fluctuating or episodic manifestations when the potential for tolerance or dependence is a sustained factor. Data for certain groups remain insufficient.


Evidence for Use in Acute Alcohol Withdrawal Syndrome

This medication was evaluated in studies focused on the immediate stabilization of patients experiencing acute alcohol withdrawal, a condition involving periods of heightened symptoms. Research mostly involved Randomized Controlled Trials (RCTs) and comparative studies examining temporary physiological imbalance. Studies primarily monitored outcomes related to physiological strain or stress, particularly the incidence of acute events such as seizures or delirium tremens, using standardized severity scales.

Studies report how symptoms evolved in the observed populations, indicating that research highlights changes measured during the study period on the withdrawal severity scales over the first few days of treatment. Findings describe patterns observed in the studies related to research describing conditions associated with acute or disruptive episodes.


Evidence for Use in Skeletal Muscle Spasms

Diazepam Labesfal was studied for its effect on conditions where symptoms may vary in intensity, such as skeletal muscle spasms. This research was observed in RCTs and various observational settings evaluating daily-life functioning. Key outcomes related to physical discomfort were studied for their change, including muscle tone scores and patient-reported outcomes describing perceived discomfort. Research highlights changes measured during the study period, noting that findings indicate patterns of measurable change in muscle tone scores over short time intervals.

Comparative evidence is lacking regarding outcomes of long-term studies comparing functional measures versus non-drug or physical interventions. Evidence quality varies across studies due to the wide range of underlying causes for the muscle spasms investigated.


Evidence for Use in Acute Repetitive Seizure Episodes

This medication was evaluated in research focused on immediately stopping conditions involving periods of heightened symptoms, specifically acute repetitive seizures. Studies involved Randomized Controlled Trials (RCTs) and protocols used in emergency settings. Researchers monitored outcomes describing episodic or acute changes, such as the time taken for the seizure activity to stop and the likelihood of recurrence.

Research describes its use as part of the immediate interruption protocols for conditions presenting with cycles of stability and flare-ups. The follow-up durations were limited, typically only to the hours following the acute event. The research does not determine or characterize the medication's potential use as a long-term, daily treatment for chronic epilepsy.


Summary of Research Gaps

For all indications, research has primarily focused on the acute-phase response, meaning that follow-up durations were limited. There is limited information for long-term outcomes across the board, and the data for long-term outcomes are not fully established. Evidence concerning specific populations is limited; for instance, data for certain groups remain insufficient, such as those with concurrent or comorbid conditions.

Key Studies & References

  1. Diazepam - StatPearls (NCBI Bookshelf)
  2. Benzodiazepines - StatPearls (NCBI Bookshelf) - Evidence for Seizure/Anxiety Disorders
  3. WHO Model List of Essential Medicines – 23rd List (2023) - World Health Organization (WHO)

Frequently Asked Questions (FAQ)

Common questions about Diazepam Labesfal (FAQ)


Q: How long does the effect of Diazepam Labesfal usually last?

Studies on how the medicine moves through the body show that the main active component has a long half-life, which can be up to 48 hours, and its active metabolite (a substance the body produces when breaking down the drug) can last up to 100 hours. This prolonged presence in the body contributes to an extended duration of effect.


Q: How soon after taking it might a person feel the effects?

According to official product information for the oral form, the active ingredient typically reaches its highest level in the blood approximately 1 to 1.5 hours after being taken. This is generally the time frame during which a person might begin to feel the effects, though taking the medicine with food may slow down this process.


Q: Does grapefruit juice affect how Diazepam Labesfal works?

Yes, official regulatory documents advise against or restrict the consumption of grapefruit juice. This is because grapefruit juice is documented to increase the body's exposure to the medication. This change in exposure is associated with a potential for increased side effects.


Q: What should a person know about the medicine's half-life?

The term 'half-life' refers to the time it takes for half of the drug to be eliminated from the body. Official information indicates that the active ingredient has a long half-life of up to 48 hours, and its active metabolite can last up to 100 hours. This accumulation is why regulatory documents state that a reduced starting dose is officially required for older adults.


Q: Is Diazepam Labesfal prescribed for short-term or long-term issues?

Official guidelines state that for approved conditions such as anxiety and muscle spasm, treatment is intended for the shortest possible period, generally not exceeding four weeks. Long-term use is not generally supported by clinical research for its approved indications, and official documents note that follow-up data on long-term outcomes are limited.


Q: What is the difference between this product (Labesfal) and other diazepam products?

Diazepam Labesfal is a brand-specific pharmaceutical formulation that contains the active ingredient diazepam. The brand name signifies that the product is manufactured by Labesfal, S.A., and distributed primarily within the European market. It adheres to the specific quality and composition details outlined in its regulatory product information.


Q: Is there a specific warning about using this medicine with antacids?

Regulatory documents include warnings about potential interactions. Certain common acid-reducing medicines may inhibit, or slow down, the liver enzymes responsible for breaking down the medication. This inhibition could lead to increased exposure and a higher chance of side effects.


Q: What is the standard procedure for disposing of expired Diazepam Labesfal?

Official regulatory documents mandate that expired or unused medicine must never be disposed of in household waste or flushed down toilets. The standard procedure is to return the product to a pharmacy or designated local collection scheme, in line with local regulations.


Q: Is there a generic version of Diazepam Labesfal available?

The active ingredient in this product is diazepam, which is the generic name of the medicine. This generic medicine is widely available under various brand names and forms in different markets. Diazepam Labesfal is simply one specific brand formulation.


Q: Do older adults typically experience different side effects from younger adults?

Official regulatory warnings note that while the list of side effects is generally the same, older adults have an increased risk of severe sedation and ataxia, which is a loss of physical coordination. This increased risk can lead to a higher incidence of falls. A reduced starting dose is required for this population due to changes in how the body processes the drug.


Q: Can Diazepam Labesfal cause issues with memory?

Official drug information and safety warnings note that memory problems and difficulty concentrating are possible side effects. These effects are listed in official safety information.


Q: What happens if I miss a regular dose of Diazepam Labesfal?

Regulatory patient instructions advise that if a regular dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Official guidance advises against taking two doses at the same time to make up for a missed one.


Q: Is there any risk described in official sources related to using Diazepam Labesfal long-term?

Yes, official documents include boxed warnings addressing the serious risks associated with prolonged use. These risks include the potential for abuse, addiction, and physical dependence, which can lead to severe withdrawal reactions if the medication is stopped suddenly. For these reasons, treatment is typically recommended for only a short duration.


Q: Is Diazepam Labesfal generally considered safe for use during pregnancy, according to official guidelines?

Regulatory documents state that use is generally not recommended during pregnancy due to documented risks. Specifically, use during the first trimester has been associated with suggested increases in birth defects, and use during the third trimester is associated with risks such as neonatal sedation or withdrawal symptoms in the newborn.


Q: Is Diazepam Labesfal used for anxiety that is mild or occasional?

Official indications state that the medicine is for the management of anxiety disorders or severe symptoms. Anxiety associated with the stress of everyday life is generally not listed as an indication for the medicine.


Q: Is there a connection between Diazepam Labesfal and mental health side effects, such as depression?

Official information lists psychiatric disorders as a system that can be affected by the medicine. Safety warnings specifically note that the medication may worsen existing depression and has been associated with thoughts of suicide, which may be more likely when starting treatment or when the dose is changed.


Q: Does Diazepam Labesfal affect sleep patterns?

As a central nervous system depressant, the medicine commonly causes drowsiness. Furthermore, official safety constraints note that its use is contraindicated, meaning prohibited, in patients who have Sleep Apnoea Syndrome.


Q: Are there any reported long-term effects on the brain described in studies?

Official drug summaries and literature reviews note that long-term use of benzodiazepines can lead to cognitive impairment. These effects often manifest as ongoing difficulties with memory and concentration, though definitive long-term studies detailing all possible effects are limited.


Q: Does Diazepam Labesfal interact with herbal supplements like St. John's Wort?

Official safety information warns about the potential for interaction with St. John's Wort. Taking this herbal supplement may reduce the effectiveness of the medication in managing anxiety and could also increase the risk of side effects like confusion, drowsiness, and dizziness.


Q: Is it normal to feel a change in appetite while using this medication?

Official information derived from clinical trials indicates that changes in appetite have been reported as a less common adverse effect. These changes are not typically listed among the most frequently observed side effects of the medication.


Q: What is stated about using Diazepam Labesfal before surgery?

The injection form of the drug is officially indicated for use as a premedication to relieve anxiety and tension in patients scheduled for surgery. It is important that patients inform their healthcare team if they are taking the oral form for other conditions, due to the drug’s potential to add to the sedating effects of other medications used during the procedure.


Q: What should be done if too much Diazepam Labesfal is taken?

Official guidelines state that taking too much of the drug requires immediate medical help, and one should contact emergency services or a poison control center right away. Symptoms of an overdose may include extreme drowsiness, severe confusion, and dangerously slow breathing.


How should Diazepam Labesfal be stored and disposed of?

Storage and Disposal Requirements

Official regulatory documents mandate specific conditions for the storage and disposal of Diazepam formulations.

Storage Constraints

Condition Requirement
Temperature Injectable solutions require 20 to 25 C; specific oral forms require storage below 25 C.
Protection All light-sensitive forms, including solutions, must be protected from light to maintain stability.
Child Safety The medicine must be kept out of the sight and reach of children.
Packaging Some liquid formulations are supplied in amber glass bottles with child-resistant caps.

Disposal Instructions

Unused or expired Diazepam must not be disposed of in household waste or wastewater. Disposal must be carried out according to local regulations, which typically involves returning the medicinal product to a pharmacy or designated collection scheme.

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

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