Nitrazepam tablets

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Nitrazepam tablets

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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.

Overview of Nitrazepam tablets

What is Nitrazepam Tablets? (Overview)

Property Description
Active ingredient Nitrazepam (INN)
Form Tablet (Oral formulation)
Pharmacological class Central Nervous System (CNS) Depressant, Hypnotic, Benzodiazepine
Common purpose Promoting rest and relieving tension
Origin Synthetic compound

What Type of Medicine is Nitrazepam?

Nitrazepam is a synthetic compound classified as a benzodiazepine derivative and is formally identified as a powerful Central Nervous System (CNS) depressant. This pharmacological class is defined by its ability to globally quiet the brain's electrical activity, resulting in pronounced sedative and hypnotic properties.

The core identity of Nitrazepam places it firmly within the group of medicines used to induce and maintain restfulness. Nitrazepam's primary effect is consistent with other benzodiazepines, as it enhances the inhibitory action of the GABA neurotransmitter. This means the medicine helps dampen signals that cause over-excitement in the brain. It is a single-entity pharmaceutical product, defining its therapeutic profile as a primary hypnotic agent.


Composition and Form: The Nitrazepam Tablet

The medicine is composed solely of the active ingredient Nitrazepam (INN) and is supplied in a tablet form, making it an oral formulation (solid dosage form). This standardized presentation ensures the precise delivery of a consistent dose of the active substance via the digestive tract.

Each tablet is meticulously manufactured to contain the exact amount of Nitrazepam required, alongside solid pharmaceutical excipients (binders, fillers, and stabilizers) that provide the structural integrity necessary for stable storage and controlled dissolution. The use of this single, stable dosage form, intended for the adult patient population, eliminates the variability associated with liquid measures, providing a reliable and standardized method of intake for the active ingredient.


What is the General Purpose of its Calming Action?

The general purpose of Nitrazepam's action is to reliably promote a state of sedation and tension relief by slowing down rapid neural firing across the central nervous system. This CNS depressant activity is specifically intended to quiet excessive or prolonged neurological excitability. Benzodiazepine hypnotics are used in addressing the difficulty of initiating and maintaining sleep. By enhancing the brain's natural calming mechanisms, the medicine achieves a powerful physiological effect that helps to subdue agitation and promote muscle relaxation. This targeted biological response explains its classification as a hypnotic, as the resulting state of profound restfulness is foundational to initiating or maintaining sleep.

What side effects are possible with Nitrazepam tablets?

Possible side effects and safety information

The official safety documents for Nitrazepam tablets classify potential adverse reactions primarily based on frequency and the affected body system, reflecting the medicine's central nervous system (CNS) depressant activity. The most frequently reported effects are generally linked to residual CNS depression.

Adverse Reaction Classification

Classification Examples of Officially Documented Effects
Common Drowsiness, reduced alertness, headache, muscle weakness, ataxia (impaired coordination), and general fatigue.
Frequency Not Known Anterograde amnesia, dependence, withdrawal syndrome, and serious skin reactions (e.g., Stevens-Johnson syndrome).

The main System-Organ Classes (SOC) involved are Nervous System Disorders and Psychiatric Disorders. Serious adverse reactions highlighted in regulatory texts include the development of physical and psychological dependence and withdrawal syndrome upon abrupt cessation. The potential for paradoxical reactions, such as excitement, agitation, or hostility, is also noted in official warnings.

Population and Time-Related Safety

Safety constraints detail specific risks for certain groups. Older adults are particularly sensitive to these effects, which increases their risk of falls and fractures due to ataxia. Severe hepatic insufficiency is an absolute contraindication due to the risk of hepatic encephalopathy. Regulatory information also addresses the time-related nature of risk:

  • Tolerance to the hypnotic effect may develop after a few weeks of repeated use.
  • Anterograde amnesia is noted as being more likely at higher doses, often occurring one to two hours after intake.

Furthermore, official safety notes emphasize that co-administration with other CNS depressants, including alcohol, significantly increases the risk of profound sedation and respiratory depression.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information states that an overdose of Nitrazepam tablets is characterized by an extreme exaggeration of its effects, resulting in severe Central Nervous System (CNS) Depression.

Documented Manifestations

Classification Official Regulatory Statements
Symptom Profile Manifestations include profound somnolence, confusion, slurred speech, and ataxia (impaired coordination).
Severe Outcomes The risk of coma, respiratory depression, and death is documented, especially with the co-ingestion of alcohol or opioids. Severe cases may also involve hypotension.

Required Emergency Action

Regulatory guidance mandates that immediate medical attention must be sought for serious symptoms. Urgent medical help is required if the affected individual exhibits trouble breathing, is unresponsive (passing out), or cannot be easily roused. The management approach is primarily based on supportive care to maintain a secure airway and circulatory function.

Action Official Regulatory Statements
Help-Seeking Trigger Seek immediate medical attention for trouble breathing or unresponsiveness.
Supportive Measures Supportive care is the principal measure; the antagonist Flumazenil is available but generally not recommended for routine reversal due to documented risks.

Population Note: Elderly patients are officially recognized as being more sensitive to the CNS depressant effects and may have a higher risk for adverse outcomes.

Therapeutic Uses of Nitrazepam tablets

The application of this medication is relevant across therapeutic areas involving symptoms related to increased neurological or muscular activity and subsequent functional strain. It is applied across domains where additional symptomatic support is needed to assist with patient comfort and stability, particularly in situations involving certain distressing symptoms.

It is commonly used for the short-term treatment of severe sleep disturbances in adults, addressing issues like difficulty falling asleep and frequent nocturnal awakenings. In specialized contexts, it is also relevant in pediatric care for the management of specific, severe seizure manifestations, including certain forms of myoclonic seizures and infantile spasms. This dual role contributes to easing the overall symptom load in conditions marked by heightened physiological stress.

“The application is relevant for easing distress and assists with maintaining functional stability during difficult episodes.”

The therapeutic benefit supports the patient during symptomatic phases, which may help maintain a sense of stability and contributes to easing the overall symptom load related to disturbed sleep and agitation.


Quick Fact: Relief for Acute Sleep and Seizure Symptoms The medicine is commonly used when symptoms intensify and supportive relief is needed, providing assistance in managing specific epileptic spasms and sleep initiation failures.

Regulatory References

  1. Health Canada Product Monograph for APO-NITRAZEPAM

Eligibility and Restrictions for Use

Who can and cannot use Nitrazepam tablets?

The eligibility for using Nitrazepam tablets is strictly defined by regulatory authorities based on patient age, medical history, and specific conditions. This medicine is approved for the short-term treatment of severe insomnia in adults.

Populations with Absolute Contraindications

Certain conditions are absolute non-eligibility rules, meaning the medicine must not be used. These include known hypersensitivity to benzodiazepines, Myasthenia Gravis, severe hepatic insufficiency (liver failure), and severe respiratory impairment such as significant sleep apnea syndrome or acute pulmonary insufficiency.

Age and Conditional Use Restrictions

Population Group Regulatory Status
Children & Infants Contraindicated for insomnia; allowed only for specific severe seizure types.
Geriatric Patients Use is restricted and requires a reduced dose (e.g., not exceeding half the normal adult dose).
Pregnancy/Lactation Not recommended during pregnancy and use should be avoided while breastfeeding.
Organ Impairment Use requires caution and possible dose reduction in patients with mild-to-moderate renal or hepatic impairment.

Eligibility is also constrained to short-term use only, and patients with a history of alcohol or drug abuse are required to use the medicine with extreme caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Nitrazepam's official interaction profile is characterized by two primary mechanisms: pharmacodynamic reinforcement and pharmacokinetic modification.


Pharmacodynamic Interactions

Co-administration with other Central Nervous System (CNS) depressants results in an enhanced central depressive effect, which is listed in regulatory documentation as a significant risk. This includes concomitant use with Antipsychotics, Barbiturates, Anxiolytics, Antidepressant agents, Anaesthetics, Sedative Antihistamines, and Muscle Relaxants.

  • The combination with Alcohol must be avoided due to the potential for severe additive CNS depression.
  • Co-prescribing with Opioids is highly restricted and must be reserved only for situations where alternative options are not possible, due to the increased risk of profound sedation and respiratory depression.
  • Conversely, Xanthine derivatives such as Theophylline or Aminophylline are documented to potentially decrease the sedative effects of nitrazepam.

Pharmacokinetic Interactions

Interactions that affect the clearance of nitrazepam through hepatic enzymes are also documented. Inhibitors of hepatic enzymes, notably Cimetidine and certain Macrolide Antibiotics, may reduce the clearance of nitrazepam, leading to increased plasma concentration. Conversely, hepatic enzyme inducers such as Rifampicin are associated with potentially increasing the drug's metabolism and reducing its exposure.

Furthermore, the drug is formally contraindicated in the presence of severe hepatic insufficiency due to the high risk of drug accumulation and prolonged elimination. The label also contains a time-dependent administration rule, requiring that the medicine not be taken when a full night's sleep and drug clearance are not possible before the patient resumes activities requiring full alertness.

Mechanism of Action

Nitrazepam operates as a positive allosteric modulator of the gamma-aminobutyric acid type A ( GABA A) receptor complex, which is the principal inhibitory neurotransmitter system in the central nervous system (CNS). The drug achieves this by binding specifically to the benzodiazepine binding site located on the interface of the GABA A receptor's alpha and gamma subunits.

This binding event induces a conformational change in the receptor structure. Mechanistically, this modification increases the affinity of the endogenous GABA ligand for its own binding site, but does not directly activate the receptor itself. The consequence is an enhanced frequency of chloride channel opening events when GABA is present.

The resulting greater influx of negatively charged chloride ions ( Cl^-) across the neuronal membrane causes hyperpolarization of the neuron. This change in membrane potential raises the threshold for generating an action potential, leading to a system-wide reduction in neuronal excitability and signal transduction within the CNS. The molecular interaction modulates neural circuits without referring to clinical outcomes.

Dosage and Administration Information

The administration of Nitrazepam tablets is governed by a strict protocol concerning route, timing, and constrained duration.

Administration Route and Strength

The medicine is an oral tablet formulation, supplied in standard 5 mg and 10 mg strengths. The 5 mg tablet is typically scored, permitting it to be divided into equal halves for precise dose adjustments when required by a prescribed regimen.

Dosing and Frequency Patterns

For short-term hypnotic use in standard adult populations, the starting dose is generally 5 mg once daily. This may be increased to a maximum of 10 mg once daily. The tablet is administered just before retiring for the night to adhere to the required timing. Dosing is structurally reduced for specific groups: the starting dose for older adults is typically 2.5 mg to 5 mg, and the maximum dose should not exceed 5 mg once daily. Dosage reduction is also necessary for patients with hepatic or renal impairment.

Duration and Cessation Protocol

Use of this medicine is designated as strictly short-term and should not exceed four weeks in total. This maximum duration includes the time necessary for the required dose reduction. When treatment is concluded, the dose must be gradually reduced (tapered off) and not stopped abruptly.

Recent Clinical Evidence

Research evidence / Overview of studies for Nitrazepam tablets

Evidence for Use in Short-Term Severe Sleep Disturbances

The research for Nitrazepam tablets in the context of sleep disturbances primarily consists of short-term Randomized Controlled Trials (RCTs). These studies were used in research exploring how symptoms change over time, comparing the medicine to a placebo (an inactive substance) and other substances used in trials. Researchers examined various outcomes related to systemic or functional imbalance, including the actual time it took participants to fall asleep (sleep latency) and the total time spent sleeping. Studies monitored sleep parameters and reported measurements of reduced sleep latency and increased total sleep time in the observed populations over a short period. This evidence contributes to the broader research landscape for conditions characterized by episodic manifestations of insomnia.

What remains uncertain is the durability of these observations due to the short-term design of the trials. Follow-up durations were limited, meaning there is limited information for long-term outcomes. Research highlights that the development of tolerance is a key research question for long-term use, and long-term effects are not fully established.

Evidence for Use in Specific Seizure Manifestations

Nitrazepam was studied for its use in children with severe seizure syndromes, specifically Infantile Spasms (West Syndrome). The research explored short-term symptom changes primarily through comparative clinical trials. Studies monitored outcomes describing episodic or acute changes, focusing on the frequency of the epileptic spasms and, in some research, the resolution of abnormal electrical activity in the brain (known as hypsarrhythmia), which are outcomes monitored in these studies. The studied populations were infants and young children with this condition.

Sample sizes were modest in the studies conducted on these rare pediatric conditions. Data for certain groups remain insufficient, particularly concerning the long-term impact on the children’s cognitive or developmental outcomes beyond the immediate treatment phase. Research describes that the observed change in spasm frequency may decline over time in the studied populations.

What is Still Uncertain About Nitrazepam Tablets Research

A primary research limitation frame is the historical nature of many key studies, meaning the evidence quality varies across studies. Comparative evidence is lacking against many current, alternative therapies, which limits the scope of findings. Furthermore, long-term effects are not fully established for either sleep or seizure outcomes, which is a major gap. The evidence highlights what is known — and what is still uncertain — regarding sustained outcomes and the risk of tolerance development after extended use.

Key Studies & References APO-NITRAZEPAM Product Monograph (Health Canada)

Frequently Asked Questions (FAQ)

Common questions about Nitrazepam tablets (FAQ)


Q: What are the typical conditions or uses that Nitrazepam tablets are prescribed for?

Regulatory documents describe the medicine’s primary indication for the short-term treatment and relief of severe sleep disturbances, known as insomnia. Official information also notes its use in the management of specific, severe seizure syndromes in certain populations.


Q: How quickly do people typically expect to feel the effect after taking a Nitrazepam tablet?

Studies on the medicine’s activity show that peak concentrations in the bloodstream are typically reached about three hours after the tablet is taken. Regulatory protocol describes that the medicine is administered just before going to bed to align with its timing requirements.


Q: Can Nitrazepam tablets affect my ability to drive or operate machinery?

Yes, official warnings state that the medicine can affect performance at skilled tasks. The ability to drive or use machinery may be negatively affected due to possible side effects like sedation, memory impairment, difficulty concentrating, and impaired muscular function.


Q: Is Nitrazepam tablets generally suitable for use in older adults?

Official information states that use in older adults requires caution, and a reduced dosage is necessary. Older adults may experience increased sensitivity to the medicine's effects, and official documents note an increased risk of impaired coordination and falls in this population.


Q: Can people with a history of breathing problems or respiratory issues take Nitrazepam?

The medicine is formally contraindicated in cases of severe respiratory impairment, such as significant sleep apnoea syndrome. This means its use is ruled out by regulatory documents. Official warnings also advise avoiding its use in patients who may have carbon dioxide retention.


Q: Is there any official information about the risk of becoming dependent on Nitrazepam tablets?

Official documents state that the use of this medicine may lead to the development of physical and psychological dependence. The risk is described as increasing with higher doses and longer periods of use. For this reason, official guidance emphasizes that treatment should be short-term.


Q: Can Nitrazepam tablets cause changes in mood or behavior?

Yes, rare behavioral effects, which are sometimes called paradoxical reactions, have been reported in official documents. These can include excitement, aggression, irritability, restlessness, confusion, or inappropriate behavior.


Q: Does Nitrazepam tablets have a boxed warning or specific regulatory caution?

The medicine carries specific regulatory cautions from governmental agencies. These include prominent warnings regarding the risk of abuse, addiction, and the potential for profound sedation and breathing difficulties when taken simultaneously with opioid medicines.


Q: Is there a concern about 'rebound insomnia' after stopping Nitrazepam?

Official documents describe that a withdrawal syndrome can be experienced when treatment is stopped, particularly if done abruptly. This includes the transient reappearance of symptoms that led to treatment, such as rebound insomnia, where the original sleep difficulty returns in an enhanced form.


Q: Can Nitrazepam affect memory or cause amnesia in some users?

Official safety information states that the drug may induce a type of memory loss called anterograde amnesia (impaired recall of events that occurred after taking the medicine). This condition is noted as being more likely at higher doses.


Q: Does Nitrazepam affect blood pressure or heart rate?

Vascular disorders are listed as a rare possible side effect in official documents. These reports include instances of hypotension, which is low blood pressure.


Q: Can the effectiveness of Nitrazepam decrease over time with continued use?

Official safety information describes that tolerance to the sleep-inducing effects of the medicine may develop. This means that after consistent, repeated use over a few weeks, the medicine may not work as well as it did initially.


Q: Is it possible to have an allergic reaction to Nitrazepam tablets?

Known hypersensitivity to benzodiazepines is a formal contraindication. Additionally, rare reports of allergic skin reactions, such as a rash, are listed as possible side effects in official safety documents.


Q: What is the regulatory status of Nitrazepam tablets in countries outside the US?

Regulatory authorities in various countries, including the United Kingdom and Canada, classify Nitrazepam as a medicine subject to strict control and scheduling. This indicates its pharmacological profile warrants tight monitoring due to its potential for abuse and dependence.


Q: Can a person develop tolerance to the effects of Nitrazepam tablets?

Yes, regulatory documents note that tolerance to the medicine's sleep-inducing effect may develop after consistent, repeated use over a period of a few weeks. The development of tolerance is noted in the official safety information regarding repeated use of this medicine.


Q: Is Nitrazepam recommended for short-term or long-term sleep issues?

Regulatory documents explicitly restrict the use of this medicine to the short-term treatment of insomnia. The maximum recommended duration for use, including the tapering period, is generally not more than four weeks.


Q: What are some common substances or drugs that are known to interact with Nitrazepam?

Interactions include an enhanced depressant effect when taken with other Central Nervous System (CNS) depressants such as antipsychotics, certain antidepressants, and opioids. Additionally, certain liver enzyme inhibitors may be known to affect how the body processes the medicine.


Q: Are there any specific food items or drinks that should be avoided when taking Nitrazepam?

The tablet may generally be taken with or without food. However, official information notes that xanthine derivatives, such as caffeine, may decrease the sedative effects of the medicine.


Q: Can Nitrazepam tablets make existing depression symptoms worse?

Official warnings state that the medicine should not be used on its own to treat depression or anxiety associated with depression. This is because there is a regulatory concern that this usage may precipitate a severe change in mood or suicidal tendencies.


Q: Is Nitrazepam the same type of medicine as sleeping pills I can buy over the counter?

Nitrazepam is chemically classified as a benzodiazepine and is designated as a controlled drug requiring a prescription from a healthcare provider. This classification indicates it is pharmacologically distinct from over-the-counter sleep aids, which are typically non-scheduled medicines.


Q: What are the signs that a person may be experiencing paradoxical side effects from Nitrazepam?

Paradoxical reactions are behavioral effects opposite to the expected calming effects. Signs described in official documents include excitement, agitation, aggression, irritability, rages, delusions, and hallucinations.


Q: Does Nitrazepam tablets contain lactose or other inactive ingredients I should know about?

Yes, regulatory documents and patient information leaflets note that Nitrazepam tablets contain lactose. This information is provided in the patient leaflet for individuals with known intolerance to some sugars.


Q: What are the official recommendations if I experience a severe side effect?

Official patient guidance consistently emphasizes the need to take action if severe side effects occur. Any serious or severe reaction warrants promptly contacting a healthcare professional or seeking emergency medical attention.


Q: What happens if I miss a dose of Nitrazepam?

General regulatory guidance for sleep use describes taking the missed dose only if sufficient time remains for a full night’s sleep (typically seven to eight hours). Official instructions advise against doubling the next dose to compensate for a missed one.


Q: How does the half-life of Nitrazepam compare to other benzodiazepines?

The time it takes for half of the medicine to be eliminated from the body (the elimination half-life) is reported to be approximately 30 hours in young adults. Due to this slow rate of elimination, the medicine can accumulate in the body when taken every night.

How should Nitrazepam tablets be stored and disposed of?

Storage and Disposal of Nitrazepam Tablets

Nitrazepam tablets must be stored at or below 25 C or 30 C, depending on the specific formulation's regulatory document. The product must be protected from light and kept in its original container or a well-sealed container to maintain stability. A mandatory safety instruction on all labeling is to keep this medicine out of the sight and reach of children.

Disposal Requirements

Regulatory instructions state that unused or expired Nitrazepam tablets must not be thrown away via wastewater or general household waste. Disposal must adhere to local requirements, typically by using an authorized drug take-back program. If a take-back site is unavailable, the medicine should be mixed with an unappealing substance, sealed in a container, and placed in the trash according to official governmental guidance.

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

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