Nitram

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Nitram

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Medically reviewed

Rosario Oropesa

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 Nitram

Property Description
Active ingredient Nitrazepam
Form Tablets (Oral solid)
Pharmacological class Benzodiazepine, CNS Depressant
Common use Hypnotic (to promote rest) and Sedative
Origin Synthetic compound

What Type of Medicine is Nitram?

Nitram is a Prescription-only medicine containing the Active ingredient Nitrazepam. This Synthetic compound is firmly classified within the Benzodiazepine pharmacological class. This medical classification indicates that the drug primarily functions as a potent Central Nervous System (CNS) Depressant, actively reducing specific excitability within the brain and nervous system.

The Active ingredient, Nitrazepam, is clinically recognized for its strong hypnotic profile compared to other Benzodiazepine agents, which often emphasize anti-anxiety or muscle relaxation. As a single Active ingredient product, its effect is derived purely from the Nitrazepam compound. This primary function is to induce sleep and deep rest, distinguishing its specific role among related sedative medications.

Understanding the Form and General Purpose of Nitram

Nitram is typically presented as Tablets, a standard Drug form designed for the Oral Route of administration. This measured Tablets format provides consistent and stable delivery of the Active ingredient for use outside of inpatient settings.

The general purpose of Nitram is defined by its powerful CNS Depressant effect. It functions as a potent Hypnotic and Sedative agent, intended to promote profound sedation and mental tranquility. Nitrazepam's profile allows it to minimize excessive neural and motor agitation. The medicine functions by stabilizing the nervous system when needed to achieve rest, such as during periods of significant restlessness or excitation.

Regulatory References

  1. Nitrazepam Summary of Product Characteristics (SmPC)

What side effects are possible with Nitram?

Possible Side Effects and Safety Information

This information describes the documented adverse reactions and safety restrictions for Nitram, based strictly on official government regulatory documents.

Adverse Reactions

The most frequent adverse reactions reported in clinical studies include headache, diarrhea, nausea, and vomiting. These effects are common, with some, such as headache and diarrhea, documented at an incidence greater than 10%. Other common adverse effects (incidence ge 5%) include flushing, jaw pain, pain in extremity, and abdominal discomfort.

Adverse effects are categorized by the body systems they affect, with frequent reports involving the Nervous System (headache, jaw pain), the Gastrointestinal System (diarrhea, nausea), and the Vascular System (flushing).

Serious Risks and Safety Limitations

Abrupt Discontinuation Risk: A critical safety limitation is the potential for acute clinical deterioration, including the worsening of underlying pulmonary arterial hypertension (PAH) symptoms, if Nitram is discontinued abruptly or if the dose is rapidly reduced. Patients must avoid sudden changes to the regimen.

Bleeding Risk: Use of Nitram, which is documented to inhibit platelet aggregation, carries an increased risk of bleeding. This risk is particularly noted when the medicine is used concurrently with anticoagulants.

Concomitant Use: Regulatory documents highlight an increased risk of symptomatic hypotension when Nitram is administered alongside other antihypertensive agents or vasodilators.

Population Considerations: Caution is necessary when administering Nitram to certain populations. Individuals with severe hepatic impairment (Child-Pugh Class C) should not use this medicine. Furthermore, the medicine is categorized as Pregnancy Category C, indicating potential harm based on animal studies.

Overdose and Emergency Response

Overdose with Nitram (Nitrazepam) is characterized by a spectrum of Central Nervous System (CNS) depression as detailed in regulatory documents. Initial manifestations include drowsiness, mental confusion, and lethargy. In more serious cases, symptoms may progress to physical signs such as ataxia (loss of coordination) and decreased muscle tone (hypotonia), potentially leading to coma. The critical physiological complications are respiratory depression (slow or shallow breathing) and hypotension (low blood pressure).

Regulators explicitly state that immediate medical attention must be sought upon the observation of severe symptoms. This mandate applies when an individual exhibits slow or shallow breathing, extreme difficulty waking up, or unresponsiveness. Contacting emergency services is required when severe complications, such as trouble breathing or passing out, are present. Life-threatening risk is primarily associated with the co-ingestion of other CNS depressants, including alcohol.

The mandated management approach is symptomatic and supportive treatment, requiring close observation and continuous monitoring of respiratory and cardiovascular functions. While Flumazenil is recognized as the specific benzodiazepine antagonist, its routine use is cautioned against due to the risk of precipitating complications. Elderly patients are noted to have increased susceptibility to the CNS depressant effects, and neonates exposed near birth may exhibit effects like hypotonia and respiratory depression.

Therapeutic Uses of Nitram

What Nitram Treats: Main Uses and Benefits

Nitram (Nitrazepam) is generally used in clinical contexts where additional symptomatic support is needed for distressing symptoms related to sleep and neurological activity.

This medication is commonly used to help manage symptom clusters that may become intense or disruptive, specifically targeting severe short-term insomnia and the supportive control of certain epileptic spasms in pediatric contexts. It is relevant in conditions characterized by periods of heightened symptoms, such as pronounced difficulties in falling asleep, frequent nocturnal awakenings, and excessive mental restlessness.

The drug provides support that helps ease the overall symptom burden, contributing to easing the overall symptom load during periods when symptoms of sleeplessness or agitation interfere with daily functioning. This is relevant in contexts involving heightened systemic burden where symptomatic assistance is needed to achieve rest.


Quick Fact: Relief for Severe Sleep and Agitation

Nitram is applied in clinical settings that involve acute symptom patterns, may assist with maintaining a sense of stability when symptoms are more noticeable, and supports patients during difficult episodes of heightened discomfort.

Eligibility and Restrictions for Use

Official Eligibility and Restrictions for Nitram

Nitram (Nitrazepam) is contraindicated in several populations due to the risks associated with its action as a CNS depressant. Absolute prohibitions apply to patients with severe hepatic insufficiency or severe liver disease, Myasthenia Gravis, severe respiratory impairment (e.g., significant sleep apnea syndrome or acute pulmonary insufficiency), and known hypersensitivity to benzodiazepines.

Eligibility Status Population/Condition
Contraindicated Children (for the hypnotic use, not anticonvulsant)
Not Recommended Pregnancy or Lactation
Restricted Use Elderly Patients

Use for insomnia is contraindicated in children, though the medicine is approved for the supportive management of specific epileptic spasms in infants and children. Elderly patients require a reduced initial dosage and use with caution due to the risk of falls and increased sensitivity. The medicine is not recommended during pregnancy and discouraged during lactation. Additionally, use requires extreme caution in patients with a history of alcohol or substance abuse or those with chronic renal disease.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Nitram (Nitrazepam) is characterized primarily by pharmacodynamic reinforcement and alterations in metabolic clearance, according to regulatory documentation. The most significant concern involves combining the medicine with other Central Nervous System (CNS) depressants.


Pharmacodynamic and Contraindicated Interactions

Co-administration with other depressant agents, including opioid medicines, results in an enhanced central depressive effect, officially leading to risks of profound sedation, respiratory depression, and adverse outcomes. Regulatory warnings emphasize limiting the dose and duration of co-administration with opioids.

Classification Interacting Substance/Class
Contraindicated Alcohol (ethanol)
Major Interaction Opioid Analgesics
Additive Effect Antipsychotics, Hypnotics, Sedative Antihistamines, Antidepressants

Metabolic Clearance and Exposure

Nitram's plasma concentration can be altered by medicines affecting the liver's enzyme systems. Substances that inhibit hepatic enzymes (e.g., Cimetidine, Isoniazid) may reduce the medicine's clearance, thereby increasing drug exposure. Conversely, enzyme inducers (e.g., Rifampicin, St. John's Wort) may increase clearance, potentially reducing effectiveness.

Population-Specific Notes

Official labeling specifies that elderly or debilitated patients are more susceptible to adverse effects from interactions, necessitating dose adjustments. Similarly, patients with hepatic impairment may experience prolonged clearance, increasing interaction risk.

Mechanism of Action

Targeting the GABA A Receptor

Nitram's primary action is to function as a positive allosteric modulator at the GABA A receptor in the Central Nervous System (CNS), the key biological target for central inhibition. This engagement enhances the effect of the inhibitory neurotransmitter GABA by binding to a site distinct from the GABA recognition site. This interaction increases the frequency of the receptor's chloride channel opening and initiates a fundamental shift in neuronal communication.


Enhancing Inhibitory Neurotransmission and Systemic Effects

This molecular binding triggers a mechanistic cascade: the enhanced opening of the receptor channel drives a greater influx of negatively charged chloride ions (Cl^-) into the postsynaptic neuron. This action leads to hyperpolarization and a significant reduction in the neuron's overall ability to fire an action potential. The widespread suppression of neural excitability across the cortex, limbic system, and spinal cord results in a generalized CNS depressant effect. This systemic modulation of activity produces core physiological consequences such as sedation, reduced muscle tone, and elevated neuronal seizure threshold, consistent with an overall reduction in central nervous system excitability.

Dosage and Administration Information

Nitram is administered via the oral route, primarily as tablets, and is typically taken once daily. Standard administration involves swallowing the dose just before going to bed and only when there is an opportunity for an uninterrupted period of sleep lasting 7 to 8 hours.


Official Dosing and Duration Principles

Treatment is intended for short-term use only, and the total duration, including the necessary dose-tapering process, generally does not exceed four weeks for insomnia. The medicine is often taken on an intermittent basis where possible.

Population Group Standard Labeled Dosage Range
Standard Adults The usual starting dose is 5 mg before retiring, which may be increased to a maximum of 10 mg.
Older Adults / Debilitated Patients A reduced starting dose of 2.5 mg is recommended, and the dose generally does not exceed 5 mg.
Children Use as a hypnotic is generally not recommended or contraindicated for those under 18 years of age.

Administration Protocol

Therapy is not stopped abruptly; the dosage is progressively decreased gradually over time to discontinue treatment. Due to its long elimination half-life, clinical monitoring is standard at the start of treatment to prevent accumulation. If a dose is missed and the remaining time before waking would not allow for the recommended 7 to 8 hours of sleep, the missed dose is not taken until the next scheduled time.

Recent Clinical Evidence

Nitram: Recent Clinical Evidence

Clinical research on Nitram (Nitrazepam, a benzodiazepine) has consistently focused on its approved indication for the short-term management of insomnia (difficulty falling or staying asleep). The body of evidence, primarily derived from randomized, placebo-controlled trials, suggests that the use of Nitram is associated with measurable changes in sleep architecture in adult patients.

Key findings from clinical studies indicate that Nitram shortens sleep latency (the time it takes to fall asleep) and helps increase the total duration of sleep. These effects are generally observed during the initial period of treatment. Due to the risk of dependence and tolerance, clinical guidelines and product labeling emphasize that use should typically not exceed four weeks.

Efficacy Measures in Trials

Outcome Measure Research Finding (Compared to Placebo)
Sleep Latency Statistically significant reduction (shorter time to fall asleep).
Total Sleep Time Statistically significant increase in total hours slept.
Wake Time After Sleep Onset Observed reduction in nighttime awakenings.

Post-marketing surveillance and longer-term observational studies highlight the need for cautious use, particularly concerning rebound insomnia and withdrawal symptoms that may occur upon discontinuation, consistent with other medications in the benzodiazepine class. The overall findings support its role as a short-acting agent for severe, disabling, or distressing transient insomnia.

Frequently Asked Questions (FAQ)

Common questions about Nitram (FAQ)


Q: Is Nitram a generic or a brand name medicine?

A: The active ingredient in this medicine is Nitrazepam. The product name 'Nitram' is a brand name, but the tablets are also available under other brand names (e.g., Mogadon) or the generic name Nitrazepam in various markets. The generic alternative contains the same active ingredient.

Q: Is Nitram a controlled substance?

A: Yes, the active ingredient Nitrazepam is often classified internationally as a Schedule IV controlled substance. This designation is used by regulatory bodies to identify drugs that have accepted medical uses but also carry a recognized potential for abuse.

Q: What are the signs of a serious side effect of Nitram?

A: Official patient information notes that signs of a serious side effect or allergic reaction can include a severe rash, trouble breathing, swelling of the face or throat, slow or shallow breathing, or severe dizziness/drowsiness. These are signs that, if experienced, should be addressed by a healthcare professional.

Q: Can Nitram cause weight changes (gain or loss)?

A: Weight changes are generally not listed among the most frequent side effects in key patient documents. However, some older clinical literature has sometimes examined this class of medicines for minor effects on body weight.

Q: Can I take Nitram with pain relievers like ibuprofen or aspirin?

A: Strong pain killers such as opioids are known to have major warnings against co-administration due to additive central nervous system (CNS) depressant effects. While common non-opioid pain relievers are generally not listed as a primary interaction risk, consultation with a healthcare professional is necessary to review the complete list of all medications being taken.

Q: Is there a maximum age for taking Nitram?

A: Official regulatory documents do not specify a definitive maximum age limit for using the medicine. However, older adults are known to have increased sensitivity to the effects, which is why a reduced starting dose and increased caution are required.

Q: What is the official safety classification of Nitram?

A: The medicine is classified as a Prescription-only medicine and is often internationally designated as a Schedule IV controlled substance. Official labeling also designates it as Pregnancy Category C, meaning potential harm was observed in animal studies.

Q: Will Nitram affect my ability to drive or operate machinery?

A: Yes, official product information warns that the medicine is a central nervous system depressant and may make you sleepy or affect your concentration. Caution is formally advised when performing skilled tasks like driving or operating machinery.

Q: Where should I look to find the official Patient Information Leaflet for Nitram?

A: The official patient information is contained in the Package Leaflet (also called the Patient Information Leaflet, or PIL). This document should be received from the pharmacist with the medicine, and is also available on the manufacturer's or government's regulatory websites.

Q: Can Nitram affect my mood or emotional state?

A: Official documents mention that the medication may cause behavioural and mood changes. Possible effects noted include anxiety, irritability, and other changes in overall emotional state, consistent with its action on the central nervous system.

Q: What happens if I take Nitram on an empty stomach?

A: Some official product information states that the medication may be taken with or without food. This indicates that the status of the stomach contents is not considered a contraindication for administration.

Q: Can I crush or split the Nitram tablets?

A: Manipulating the tablet form is generally not recommended by regulatory standards. This is because alternative formulations (like an oral suspension) may be available, or crushing the tablet could alter the release properties beyond the prescribing instructions.

Q: Does taking Nitram affect the results of any common lab tests?

A: Yes, official labeling notes that the medicine can cause changes in the number and types of blood cells which may be reflected in the results of routine blood tests.

Q: Can Nitram affect my sexual health?

A: Official product information reports that a change in sex drive is documented as a possible side effect of the medicine.

Q: How is Nitram different from other similar medicines?

A: Official classification documents the active ingredient Nitrazepam as having a notably strong hypnotic profile compared to other medicines in the same class. This profile indicates its primary function is to promote sleep and deep rest.

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

A: According to the official patient information, the effects of Nitram can typically be felt within 1 hour after the dose is taken. This rapid onset contributes to its function for difficulty falling asleep.

Q: What is the expected duration of the effects after taking Nitram?

A: Studies and official information indicate that the active ingredient has a long elimination half-life, generally reported to be 15 to 38 hours in adults, with a mean around 26 to 29 hours. This means the medicine is present in the body for an extended period.

Q: Is feeling tired a common side effect when starting Nitram?

A: Yes, official product information includes unusual tiredness and drowsiness as possible side effects. These residual effects may sometimes persist or be noticeable the day after the medicine is taken.

Q: Are there any vitamins or supplements that interact with Nitram?

A: Official product information advises that consultation with a healthcare professional or pharmacist is recommended before using this medication alongside any other supplements or natural products. This is because some non-prescription items can affect how the medicine works in the body.

Q: Is it safe to take Nitram with blood pressure medication?

A: Regulatory documents note that taking Nitram with certain antihypertensive agents (blood pressure medicines) or vasodilators can increase the risk of symptomatic hypotension. Hypotension is defined as abnormally low blood pressure.

Q: Is it normal to feel a strange taste or dryness when taking Nitram?

A: Official documents list changes in saliva production, such as increased watering of the mouth, as a possible adverse effect. While the most frequent side effects do not usually include dry mouth or a strange taste, it is important to review the complete list of known effects.

Q: Is there a specific diet I should follow while on Nitram?

A: Regulatory warnings state that the consumption of alcohol (ethanol) is prohibited while using Nitram. Other general dietary restrictions are not typically specified in the official product information.

Q: Is it true that Nitram can affect kidney function?

A: Official labeling confirms the body eliminates the active ingredient primarily via renal excretion (the kidneys). For this reason, caution is necessary when the medicine is used by patients who already have existing chronic renal disease (long-term kidney issues).

Q: Does Nitram interact with grapefruit or grapefruit juice?

A: While not always explicitly named on product labels, the medicine is metabolized by enzymes that are known to be affected by grapefruit or grapefruit juice. Reviewing product labeling or consulting a pharmacist is important to check for specific interaction warnings.

Q: Does Nitram come in different forms (e.g., liquid, tablet)?

A: The medicine is primarily presented as a tablet intended for oral administration. While other formulations like an oral suspension may be used in certain settings, they might be considered unlicensed for this specific product depending on the market.

Q: What kind of monitoring tests might be needed while taking Nitram?

A: Official labeling advises that patients should be checked regularly at the start of treatment to prevent accumulation of the medicine. Possible side effects noted include changes in the number and types of blood cells shown in blood tests, and monitoring of liver function is important for specific patient groups.

Q: Why are there warnings about combining Nitram with certain herbal teas?

A: Warnings exist because some herbal products, such as St. John’s Wort, are known to be enzyme inducers, which means they can alter how the body clears the medicine. This may either increase or reduce Nitram’s overall effectiveness.

Q: How does Nitram affect my daily routine?

A: Official instructions require the medicine to be taken just before going to bed and only when an uninterrupted 7 to 8 hours of sleep is possible. Residual effects, like drowsiness the next day, are possible and may affect daily activities.

Q: What is the half-life of Nitram as reported in studies?

A: Studies and official information indicate that the active ingredient has a long elimination half-life, generally reported to be 15 to 38 hours in adults, with a mean around 26 to 29 hours. This means the medicine is present in the body for an extended period.

How should Nitram be stored and disposed of?

How to Store and Dispose of Nitram

Nitram (Nitrazepam) tablets must be stored strictly according to official regulatory requirements to ensure product stability and prevent unauthorized access.

Storage Environment

The medicine should be stored at room temperature, typically below 30 C (86 F). It is mandatory to protect the tablets from light and moisture, and they should be stored in a dry place. The container must be kept tightly closed and stored away from heat; official guidelines advise against storing the medicine in the bathroom.

Child Safety and Disposal

As a controlled substance, Nitram must be kept in a safe place out of the reach of children. Disposal of unused or expired tablets should be done through DEA-authorized drug take-back programs. If a take-back option is unavailable, the product must be mixed with an undesirable substance, sealed, and placed in the household trash. Tablets must not be flushed down the toilet or poured into drains.

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

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