Nitraze

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Nitraze

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 Nitraze

What is Nitraze? Defining the Benzodiazepine Hypnotic

Property Description
Active Ingredient Nitrazepam (INN)
Form Tablet
Pharmacological Class Benzodiazepine; Central Nervous System (CNS) Depressant
General Purpose Induction of sleep, sedative and anticonvulsant effects
Origin Synthetic

Nitraze is a trade designation for a synthetic pharmaceutical preparation containing the sole active substance Nitrazepam. This compound is structurally classified as a Benzodiazepine derivative and functionally as a Central Nervous System (CNS) Depressant and psycholeptic agent. The preparation is typically supplied as a tablet, intended for oral ingestion, representing the standard administration form for this class of medication.

Nitrazepam's identity is clinically recognized for its long duration of action compared to many other agents within its class. Nitrazepam acts as an inhibitory agent on the central nervous system; this core function is based on slowing down excessive brain activity.

Nitrazepam's Role and General Therapeutic Purpose

The fundamental action of Nitrazepam is to enhance the effects of the brain's main inhibitory neurotransmitter, gamma-aminobutyric acid (GABA). This results in pronounced hypnotic, sedative, and anticonvulsant physiological effects. Nitrazepam is classified as a long-acting benzodiazepine used for its pronounced sedative effects.

This mechanism translates directly into the drug's primary therapeutic purpose: to provide effective, reliable calming and control over heightened neurological states. By reducing the overall tension and excitability of the CNS, the drug is primarily utilized to induce sleep and to offer strong muscle-relaxant benefits, often reserved for conditions requiring significant, sustained sedation.

Regulatory References

  1. psycholeptic

What side effects are possible with Nitraze?

Possible side effects and safety information

The safety profile of Nitraze (Nitrazepam) is defined by its action as a central nervous system (CNS) depressant, leading to a number of officially documented adverse reactions classified by frequency and system involvement in regulatory documents.

Frequency-Classified Adverse Reactions

The most common adverse reactions listed in official product information include drowsiness, reduced alertness, fatigue, headache, dizziness, ataxia (impaired coordination), and muscle weakness. These are often most noticeable at the start of treatment. Rare documented effects include vertigo, nausea, abdominal discomfort, and urinary retention. A number of serious psychiatric and neurological reactions, such as aggression, agitation, delirium, amnesia, and respiratory depression, are also documented, but their frequency is not known according to some regulatory classifications.

Serious Safety Considerations

The official labeling notes that use may lead to physical and psychological dependence, even at therapeutic doses, with a risk of withdrawal syndrome and rebound phenomena (e.g., rebound insomnia) upon cessation. Rare but serious reactions documented include respiratory depression and severe hypersensitivity events such as anaphylactic reaction and Stevens-Johnson syndrome.

Population-Specific Notes and Constraints

Official documents indicate that older adults are particularly sensitive to the drug's effects, carrying a heightened risk of falls and hip fractures due to muscle weakness. The medicine is formally contraindicated in patients with severe conditions, including severe respiratory insufficiency, sleep apnoea syndrome, myasthenia gravis, and severe hepatic insufficiency. Furthermore, regulatory documents specify that use with alcohol and opioids is restricted due to the increased risk of profound sedation and potentially fatal respiratory depression.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation defines a Nitrazepam overdose primarily by the exaggeration of its effects, resulting in profound Central Nervous System (CNS) depression. Documented clinical manifestations range from somnolence (extreme sleepiness), ataxia (impaired coordination), and slurred speech to more severe outcomes. Life-threatening toxicity is explicitly documented, including the potential for respiratory depression (slow or shallow breathing) and progression to coma. This risk is significantly heightened by co-ingestion with other CNS depressants, notably alcohol, which increases the documented risk of death.

Official labeling requires individuals to seek immediate medical attention when an overdose is suspected or when specific severe signs—such as extreme somnolence or difficulty waking—are observed. Management, as defined by regulatory authorities, is symptomatic and supportive, focusing on maintaining a patent airway and continuous hospital monitoring of vital signs. While the benzodiazepine antagonist Flumazenil is specified as an adjunct, its use is noted to carry the risk of inducing seizures. Population-specific considerations exist, including a higher risk of falls in the elderly and pronounced ataxia in pediatric patients.

Therapeutic Uses of Nitraze

Nitraze is commonly used across conditions presenting with acute or disruptive symptom patterns, offering symptomatic relief that may help patients cope more steadily with difficult episodes. The compound is considered relevant in clinical settings involving sleep-related symptoms and is applied in addressing specific symptoms associated with epileptic spasms in infants.

Key Therapeutic Domains

Nitraze is relevant for easing symptoms related to the inability to fall asleep, frequent nocturnal awakenings, high internal tension, and involuntary motor activity. The medication is often used during phases when symptoms create noticeable physiological strain. It is commonly used across conditions presenting with severe insomnia, disabling anxiety requiring profound sedation, and the management of specific types of minor motor seizures and infantile spasms (such as West syndrome).

“This medication is considered relevant in situations where symptoms create noticeable physiological strain and require short-term symptomatic assistance.”


Quick Fact Block

Quick Fact: Relief for Key Symptom Domains Description
Severe Sleep Disturbance May assist in managing symptom groups that interfere with daily comfort, contributing to improved sleep maintenance.
Episodic Seizure Activity Is used in situations involving certain distressing symptoms related to specific symptom clusters.
Heightened Tension May assist with easing the overall symptom load associated with symptoms of increased neurological or muscular activity.

Eligibility and Restrictions for Use

Nitraze (Nitrazepam) eligibility is strictly defined by regulatory guidelines. The medicine is primarily approved for use in Adults for the short-term management of severe insomnia. However, its use is contraindicated across several patient groups. Individuals with known hypersensitivity to benzodiazepines, myasthenia gravis, severe hepatic insufficiency, or severe impairment of respiratory function (including sleep apnoea syndrome) must not use this medicine. It is also contraindicated in patients with acute porphyria or chronic psychosis.

Age Group Eligibility Status (Regulatory)
Adults Approved for short-term insomnia.
Elderly Restricted to smallest effective dose; long-term use avoided.
Children Contraindicated for insomnia; used for specific epileptic spasms.

Use is not recommended during pregnancy or breastfeeding. Furthermore, the medicine must be used with extreme caution in patients with a history of alcohol or drug abuse, and a reduced dose may be required for individuals with non-severe chronic renal or hepatic disease. These regulations define the official population limits for the drug's use.

What should I know about interactions with other medicines?

Nitrazepam's interaction profile is characterized by two main concerns: additive Central Nervous System (CNS) depression and altered drug metabolism.

Concomitant Use with CNS Depressants

Nitrazepam, as a benzodiazepine, has a strong pharmacodynamic interaction with other CNS depressants. The concurrent use of Nitrazepam with opioid pain or cough medicines is a serious risk that can lead to profound sedation, severe respiratory depression, coma, and death due to an additive effect. Health authorities strongly recommend that the co-prescribing of benzodiazepines and opioids be limited to patients for whom alternative treatment options are inadequate, and the dosage and duration should be the minimum possible. Alcohol must be avoided completely as it significantly enhances the sedative and central depressive effects. Other interacting medicine categories include anti-epileptics (e.g., barbiturates, hydantoins), antidepressants, sedative antihistamines, neuroleptics, and anesthetics.

Metabolic Interactions

The drug is metabolized by hepatic enzymes, and its concentration in the body can be affected by medicines that alter this process. Inhibitors of hepatic enzymes, such as cimetidine and certain macrolide antibiotics (e.g., Erythromycin), can slow down Nitrazepam's clearance, potentially increasing its plasma levels and effects. Conversely, hepatic enzyme inducers like Rifampicin can accelerate the clearance of Nitrazepam, which may reduce its therapeutic effectiveness.

Mechanism of Action

Targeting the GABA A Receptor

Nitraze acts as a Positive Allosteric Modulator on the GABA A receptor complex, the brain's primary inhibitory target. This mechanism enhances the functional effect of the inhibitory neurotransmitter Gamma-Aminobutyric acid ( GABA), increasing the flow of negative chloride ions ( Cl^-) into the postsynaptic neuron. This molecular action initiates the downstream cascade of reduced neuronal firing.


Systemic Reduction in Neural Excitability

The enhanced GABA signaling causes generalized Central Nervous System (CNS) depression by making nerve cells across key brain circuits less likely to fire. This modification of signaling dynamics leads to the dampening of activity in neural networks responsible for arousal and motor output. The result is a generalized reduction in neuronal activity and excitability and decreased muscle tension.


⏳ Pathway Dependency and Constraint

The mechanism's effectiveness is constrained because it depends on the presence of GABA; it cannot initiate the signal on its own. Moreover, sustained engagement of this pathway can lead to cellular adaptation, such as receptor desensitization, which is a physiological limitation that may alter the magnitude of the drug's effect over time.

Dosage and Administration Information

Nitrazepam (Nitraze) is administered exclusively via the oral route, most commonly as a tablet or oral solution. Usage guidelines establish specific dosing and scheduling patterns depending on the context of use.

For adult patients with insomnia, the treatment follows a once-daily schedule. The typical starting dose is 5 mg, taken immediately before retiring to initiate its hypnotic effect. If required for severe insomnia, the dose may be increased to a maximum of 10 mg, although a single dose of 20 mg may be permitted in a hospital setting. The medicine is explicitly designated for short-term use, with the total duration of treatment, including the necessary dose tapering period, typically not exceeding four weeks.

Dosing requires adjustments for certain populations. Older or debilitated adults must start on a reduced dose, typically 2.5 mg, which should not exceed half the dose recommended for younger adults. For the management of specific pediatric seizures, the medicine is administered in three divided doses per day, based on weight (e.g., 0.3 to 1.0 mg/kg/day). A critical procedural instruction is the requirement to ensure the patient can commit to 7 to 8 hours of uninterrupted sleep following administration. When discontinuing therapy, the dose must always be gradually tapered off rather than stopped abruptly.

Recent Clinical Evidence

Research Evidence for Short-Term Severe Sleep Disturbance

The evidence was generated in studies exploring conditions associated with acute sleeplessness and is largely derived from short-term Randomized Controlled Trials (RCTs). Research examined symptom changes by focusing on measurements of Total Sleep Duration and Sleep Onset Latency (time taken to fall asleep) in adults. Patterns observed in studies included measurements related to an increase in sleep duration compared to placebo. However, data related to objectively measuring the reduction in the time it takes to fall asleep were reported as limited or mixed across different trials, and the focus remains on acute symptom changes.


Research Evidence for Specific Types of Seizure Activity

The compound was also studied for conditions characterized by episodic changes in brain activity, specifically Infantile Spasms (West Syndrome). Research examined outcomes related to systemic or functional imbalance in RCTs that included infants and young children. The primary endpoints evaluated included the complete cessation of epileptic spasms and changes related to electroclinical remission (EEG pattern improvement). Research reported patterns of spasm cessation observed in a portion of the treated infants, but the evidence base is limited by a paucity of large-scale, prospective studies.


Limitations and Unanswered Questions

A key limitation across all research is that follow-up durations were limited, primarily characterizing acute changes. The majority of trials focused on defined time intervals, meaning data for extended use are still emerging. For other specific demographic groups, such as older adults with comorbidities, data for certain groups remain insufficient. Furthermore, evidence quality varies across studies, and the limited information for long-term outcomes represents a major area where more research is needed to contribute to the broader evidence landscape.

Frequently Asked Questions (FAQ)

Common questions about Nitraze (FAQ)

Q: What should I know before starting Nitraze?

A: Official product information emphasizes the importance of informing a healthcare provider about any severe conditions, such as severe respiratory issues, sleep apnea, or severe hepatic (liver) disease. These conditions may mean that the medicine is not appropriate or requires a modified approach. Regulatory documents also state that the presence of certain muscle disorders or a history of substance use should be reported.

Q: Are there any long-term effects of taking Nitraze?

A: Regulatory guidance describes the intended use of this medicine as short-term, typically not exceeding four weeks. Official warnings state that using the drug for longer periods significantly increases the risk of developing physical or psychological dependence. This dependency may lead to withdrawal symptoms if the medicine is abruptly stopped.

Q: Does Nitraze affect sleep patterns?

A: Studies and official information indicate that Nitraze does affect the overall sleep cycle. While it is intended to increase total sleep time, it may also impact the architecture of sleep. Specifically, it can potentially delay the onset and duration of REM sleep and decrease the time spent in the deepest sleep stages.

Q: Is Nitraze a drug that needs to be taken daily?

A: The required frequency of the medicine depends on the specific condition being addressed. For example, regulatory documents state that for the treatment of insomnia, it is typically prescribed as a once-daily dose. However, for certain seizure management, official guidance may specify that the medicine is administered in multiple divided doses throughout the day.

Q: Is Nitraze a controlled substance?

A: Yes, this medicine is classified as a Schedule IV controlled substance by official sources in several countries. This designation indicates that the drug has an accepted medical use but also possesses a potential for abuse and physical or psychological dependence.

Q: How long does it take for Nitraze to start working?

A: Studies on the drug’s pharmacokinetics indicate that its peak concentration in the blood is typically observed about three hours after a dose is taken by mouth in healthy young adults. This measurement provides an estimate of when the medicine’s main effects may begin.

Q: What happens if I forget to take Nitraze?

A: Official patient information describes the typical approach when a dose is forgotten, which is to generally skip the missed dose and continue with the regular schedule. Regulatory warnings advise against taking two doses at the same time to make up for the one that was missed.

Q: Can Nitraze cause weight gain?

A: Official lists of frequently reported side effects do not commonly include weight gain as a primary concern. However, changes in appetite are sometimes noted in the overall summary of undesirable effects for this medicine.

Q: Does Nitraze make you tired or drowsy?

A: Yes, official safety information states that drowsiness, dizziness, and a feeling of being tired are commonly reported side effects. Official safety information includes warnings that this medicine may cause sleepiness that persists and affects alertness the following day.

Q: Are there any common interactions between Nitraze and vitamins or supplements?

A: Regulatory documents primarily focus on known interactions with prescription drugs and alcohol, particularly those that cause Central Nervous System (CNS) depression. While specific supplement interactions may not be listed, official guidance typically requires that all vitamins and supplements being used be disclosed to a prescriber.

Q: Is it safe to drink coffee while taking Nitraze?

A: This medicine acts as a Central Nervous System (CNS) depressant. Regulatory guidance suggests that concurrent use of CNS stimulants, such as high amounts of caffeine found in coffee, may counteract the drug's intended effects or result in drug-induced mental excitement.

Q: Is Nitraze safe for teenagers?

A: Official product information states that this medicine is contraindicated for the short-term treatment of insomnia in children and juveniles. The use of this drug is generally restricted to specific conditions like certain pediatric seizure disorders, where a weight-based dose is calculated due to a potentially higher risk of side effects in children.

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

A: According to official regulatory documents, the most commonly reported undesirable effects include drowsiness, dizziness, headache, and loss of coordination. Other frequently reported effects include lightheadedness and the occurrence of nightmares.

Q: Does using Nitraze affect driving ability?

A: Yes, official regulatory warnings state that this medicine can impair cognitive function and coordination. Due to the potential for sedation and next-day drowsiness, its use can significantly affect a person's ability to drive or operate complex machinery safely.

Q: Is Nitraze available as a generic version?

A: In many authorized markets, official product information lists the drug under its generic name and several different brand names. This confirms that generic versions of the medicine are widely available in various regions.

Q: What kind of studies support the use of Nitraze?

A: Regulatory approval is based on clinical studies designed to establish the drug's efficacy and safety for its approved uses. For insomnia, studies measure benefits by observing objective markers like time taken to fall asleep and total sleep duration. For seizures, the primary benefit is measured by assessing changes in seizure frequency.

Q: Does Nitraze have a high risk of dependence?

A: Yes, as a member of the benzodiazepine class, this medicine carries a known risk for abuse and the development of physical or psychological dependence. Official warnings state that this risk generally increases with higher doses and longer duration of use.

Q: Can people with liver issues take Nitraze?

A: According to official product information, the medicine is contraindicated (should not be used) in patients with severe hepatic (liver) insufficiency. For individuals with chronic hepatic disease, caution is required, and a significant dosage reduction may be necessary.

Q: What is considered an overdose of Nitraze?

A: Regulatory information states that symptoms of an overdose may include extreme drowsiness, confusion, and slurred speech. More severe signs of overdose include decreased muscle reflexes and impaired breathing.

Q: Is it normal to feel a change in appetite while on Nitraze?

A: Changes in appetite are not typically listed among the most common side effects in official regulatory summaries. However, general gastrointestinal upsets are noted rarely in the overall adverse effect reports for this medicine.

Q: What should I do if I experience unexpected mood changes on Nitraze?

A: Official safety documents emphasize that patients experiencing serious mental or mood changes should receive immediate medical attention. These can include confusion, agitation, anxiety, depression, or the emergence of suicidal thoughts.

Q: Are there food restrictions when taking Nitraze?

A: Official instructions generally advise that the medicine can be taken with or without food. Taking it at the same time as food may be recommended if the medicine causes an upset stomach.

Q: Can people with kidney problems use Nitraze?

A: Official product information indicates that the use of the medicine by people with chronic renal (kidney) disease requires caution. In some cases, a dosage reduction may be necessary.

Q: What happens if I take Nitraze with alcohol?

A: Official warnings state that the simultaneous intake of alcohol is contraindicated. Alcohol enhances the sedative effects of the drug, which significantly increases the risk of severe side effects, including impaired ability to drive, respiratory depression, and potentially death.

Q: Is Nitraze safe to use during pregnancy?

A: Regulatory warnings describe that the medicine is generally not recommended during pregnancy, particularly during the first and last trimesters. Official documents note risks such as potential congenital malformations and the possibility of neonatal dependence or withdrawal symptoms in the newborn.

Q: Can Nitraze be used while breastfeeding?

A: Official guidance describes that the use of this medicine is to be avoided by mothers who are breastfeeding. This is because the drug belongs to a class of medicines (benzodiazepines) that are known to pass into breast milk.

Q: Does Nitraze interact with blood pressure medicine?

A: Regulatory documents primarily list interactions with other medicines that cause Central Nervous System (CNS) depression. Official guidance indicates that patients must inform their prescriber about all existing medications to check for potential interactions.

Q: Are there any specific safety warnings for Nitraze?

A: Key safety warnings in official documents include the potential for abuse and dependence, which means gradual withdrawal is necessary to prevent withdrawal symptoms. Furthermore, there have been rare reports of complex sleep behaviors, such as sleep-driving, which may occur while the patient is not fully awake.

Q: What does it mean if an official document classifies Nitraze as a 'Schedule X' drug?

A: When official documents classify the medicine under a controlled substance schedule (e.g., Schedule IV), it indicates that the drug has an accepted medical purpose but also possesses a potential for abuse. The schedule number reflects the relative risk of abuse and dependence compared to other controlled substances.

Q: Do I need any special monitoring while taking Nitraze?

A: Patients may be monitored closely by their healthcare providers for signs of drug use disorder, changes in mood or behavior, or the emergence of suicidal thoughts. This close observation is particularly important at the beginning of treatment or when the dosage is being adjusted.

Q: Is it common to have headaches when first starting Nitraze?

A: Yes, headaches are listed as a reported undesirable effect in official safety summaries. It is also noted that headaches are a potential symptom of withdrawal if the medicine is not tapered gradually when discontinued.

Q: How is the benefit of Nitraze measured in clinical trials?

A: Clinical trials measure the benefit of the medicine by assessing specific objective markers. For insomnia, this includes recording the time taken to fall asleep, total sleep time, and the duration of time spent awake during the night. For seizures, benefit is measured by assessing changes in the frequency of seizure events.

Q: What are the main contraindications for using Nitraze?

A: Official contraindications—reasons the drug must not be used—include hypersensitivity to benzodiazepines, severe respiratory insufficiency, and sleep apnea syndrome. Other major contraindications involve severe hepatic (liver) insufficiency, the muscle disorder myasthenia gravis, and and using the drug for insomnia in children.

Q: What is the difference between the immediate-release and extended-release forms of Nitraze?

A: Official regulatory documentation typically lists the available oral dosage forms as a tablet and an oral solution. These documents do not commonly differentiate between immediate-release and extended-release versions, suggesting that a standard release formulation is the primary available form.

Q: How long does the effect of one dose of Nitraze last?

A: The medicine has a long elimination half-life, which is the time it takes for half of the drug to be cleared from the system. For young adults, this is approximately 30 hours, meaning the effects can persist throughout the next day and the medicine can accumulate with repeated nightly use.

Q: Why do people sometimes misuse Nitraze?

A: Misuse of this drug is linked to its official classification as having potential for abuse. Regulatory context indicates that the drug may be misused to enhance the effects of other substances or used to manage withdrawal symptoms from other drugs.

Q: Can Nitraze be crushed or chewed?

A: Official administration guidance for the tablets states that they may be swallowed whole, or they may be crushed or dissolved in liquid. Regulatory guidance states that specific instructions from a prescribing healthcare professional should always be followed.

How should Nitraze be stored and disposed of?

How to Store and Dispose of Nitraze?

Nitrazepam tablets must be stored at controlled room temperature, typically between 15 C and 30 C (59 F and 86 F). The product must be stored in its original container and be protected from light and moisture. Liquid formulations must be stored below 25 C and must not be frozen.

All forms of this medication must be stored strictly out of the sight and reach of children.

Disposal

Regulatory instructions state that unused or expired nitrazepam should not be thrown away via wastewater or household waste. For proper disposal, patients should ask a pharmacist for guidance on using an official take-back program or following local regulations for pharmaceutical waste.

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

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