Nitrom

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Nitrom

Medically reviewed

Laura Arias

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 Nitrom

Property Description
Active Ingredient Nitrazepam (C15H11N3O3)
Form Tablet (Oral Preparation)
Pharmacological Class Benzodiazepine Derivative, CNS Depressant
General Purpose Sedative, Hypnotic, Anticonvulsant
Origin Synthetic, Prescription-Only Drug

What is Nitrom and What is its Classification?

Nitrom is a prescription-only medicine whose active ingredient is Nitrazepam, a specific psychotropic drug classified as a Central Nervous System (CNS) Depressant. It belongs to the Benzodiazepine derivative family, which defines its foundational mechanism of action by enhancing inhibitory signaling in the brain. The active substance, Nitrazepam (C15H11N3O3), is a synthetic compound, ensuring manufacturing consistency and precise chemical purity. The compound possesses a potent ability to reduce central nervous system excitability, confirming its role in treating hyperexcitable states.


What are the Composition and Form of Nitrom?

Nitrom is supplied as an oral preparation in a solid tablet dosage form, making its intended route of administration oral. It is defined as a single-active-ingredient product, containing only Nitrazepam as the pharmacologically active component. Unlike some related benzodiazepines which may be formulated for intravenous use, Nitrom is specifically positioned for oral, systemic absorption. The tablet composition includes the active substance combined with appropriate pharmaceutical excipients and binders required for stability and systemic delivery.


What is the General Therapeutic Purpose of Nitrazepam?

The general therapeutic purpose of the Nitrazepam component is to exert a comprehensive calming and stabilizing influence on the brain, consistent with its designation as a sedative-hypnotic. This high-level utility stems from its ability to enhance GABAergic neurotransmission, which fundamentally slows down excessive neuronal activity. Consequently, the drug is primarily utilized to facilitate restful sleep and reduce overall nervous system agitation and tension, acting also as a central muscle relaxant and anticonvulsant.

What side effects are possible with Nitrom?

Possible side effects and safety information

The officially documented safety profile for Nitrazepam (Nitrom) is anchored by its action as a Central Nervous System (CNS) depressant. Adverse reactions are classified by frequency and system-organ class in regulatory labeling.

Frequency-Classified Adverse Reactions

Adverse effects are categorized based on their documented occurrence rates:

Classification Examples of Documented Effects
Common (up to 1 in 10) Drowsiness, Reduced alertness, Ataxia, Muscle weakness
Rare (up to 1 in 1,000) Confusion, Vertigo, Hypotension, Jaundice, Respiratory depression, Nausea, Allergic skin reactions

Serious Safety Concerns and Restrictions

Regulatory documents explicitly address clinically significant risks. The use of Nitrazepam is associated with the potential for physical and psychological dependence, with the risk increasing alongside the duration of treatment. Abrupt cessation may lead to a withdrawal phenomenon or rebound symptoms. Anterograde amnesia (impaired memory formation post-dose) is a documented risk, typically occurring one to two hours after ingestion. Furthermore, use with opioids or other CNS depressants carries a high-level safety warning due to the significantly increased risk of severe sedation and respiratory depression.

Safety is formally constrained by contraindications, which include pre-existing conditions such as Myasthenia gravis, Severe respiratory insufficiency, Sleep apnoea syndrome, and Severe hepatic insufficiency. Older adults are identified as a population with heightened sensitivity to adverse effects, carrying an increased risk of confusion, falls, and subsequent fractures.

Overdose and Emergency Response

Overdose and when to seek help

Overdose of Nitrazepam (Nitrom) is officially documented by regulatory authorities as primarily resulting in a spectrum of Central Nervous System (CNS) Depression. Initial manifestations typically include somnolence, confusion, slurred speech, and decreased muscle reflexes. This condition may progress to a stuporous state or coma in severe cases.

The most serious, life-threatening outcome documented is respiratory depression—slowed or difficult breathing—which carries the risk of respiratory arrest and death. This risk is significantly magnified when Nitrazepam is combined with other CNS depressants, notably alcohol or opioids.

Immediate medical attention is required whenever signs of severe toxicity appear. Government guidance explicitly instructs individuals to call 911 or local emergency services if the patient is unresponsive, is passing out, or is exhibiting any trouble breathing. A poison control center should also be contacted.

Management protocols focus on providing supportive care. While a specific antagonist, Flumazenil, is available, its use is generally cautioned against in routine management due to the documented risk of precipitating seizures. Regulatory documents also note that elderly patients and those with existing hepatic or renal impairment are more susceptible to overdose risks due to drug accumulation.

Therapeutic Uses of Nitrom

What Nitrom Treats: Main Uses and Benefits

This medication is primarily used to address symptom clusters that may become intense or disruptive, such as the discomfort, pressure, or tightness in the chest known as angina pectoris. It is applied to provide symptomatic relief during an acute episode and may assist with preventing these episodes. This contributes to comfort during symptomatic periods. The medicine is commonly used in conditions presenting with acute episodes and recurrent or episodic manifestations, including angina pectoris due to coronary artery disease, high blood pressure emergencies, and pain associated with chronic anal fissures. It is applicable within clinical settings that involve acute or disruptive symptom patterns and to address anticipated symptomatic discomfort.

It is relevant in clinical settings marked by symptoms that create noticeable physiological strain. It is generally applied across domains where additional symptomatic support is needed to moderate pronounced symptoms related to systemic imbalance or localized spasms. This helps to ease the overall burden on the circulatory system and supports the patient during symptomatic phases.

“This medication is considered relevant when supportive symptom management is appropriate, assisting patients during difficult episodes by easing discomfort.”

Quick Fact: Relief for Chest Discomfort and Vascular Strain The primary therapeutic benefit is in helping to ease symptoms linked to organ-specific functional stress (the heart) and symptoms related to systemic imbalance (blood pressure), supporting the patient when symptoms escalate temporarily.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Official Eligibility Rules for Nitrom (Nitrazepam)

Eligibility to use Nitrom is strictly determined by regulatory documents, focusing primarily on the patient’s age, organ function, and specific pre-existing conditions. These rules define who may receive the medicine and who is absolutely prohibited from using it.

Eligibility Status Applicable Populations and Conditions
Absolute Contraindication (Must NOT Use) Patients with Severe Hepatic Insufficiency or Severe Respiratory Insufficiency, including Sleep Apnoea Syndrome and Acute Pulmonary Insufficiency. Also contraindicated in patients with Myasthenia Gravis or known Hypersensitivity to the medicine or any other benzodiazepine [Source 1.1, 1.4].
Age-Related Non-Eligibility Use as a hypnotic is contraindicated in children. For older adults and the debilitated, use is permitted, but the starting dose must be significantly reduced due to an increased risk of adverse effects, including falls [Source 1.7, 1.9].
Conditional or Restricted Use Caution is advised for patients with Chronic Renal, Hepatic, or Pulmonary Disease, and dosage may need to be adjusted. The medicine should not be used alone to treat patients with depression [Source 1.7].
Pregnancy and Lactation Use during Pregnancy is not recommended. Use while Breastfeeding should be avoided as the medicine is excreted in maternal milk and may accumulate in the infant [Source 1.2, 1.10].

These official regulatory requirements ensure that the medicine is only used by populations where the risk profile is deemed acceptable by health authorities, excluding individuals whose pre-existing conditions could be severely exacerbated by the medicine’s central nervous system depressant properties.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Nitrom (Nitrazepam) interactions are primarily defined by the risk of enhanced central nervous system (CNS) depression and changes to the drug's metabolism.


Interaction Type Interacting Substances (Examples) Regulatory Constraint/Basis
CNS Depressant Reinforcement Alcohol, Opioids, Sedative Antihistamines, Other CNS Depressants Additive pharmacodynamic effects may lead to profound sedation, respiratory depression, coma, and death. Concomitant use with alcohol must be avoided. Use with opioids is strongly cautioned and should be limited in dosage and duration.
Metabolism & Clearance Cimetidine, Macrolide Antibiotics, Azole Antifungal Agents, Grapefruit Juice These substances may inhibit hepatic enzymes (Cytochrome P450), which reduces Nitrom's clearance, potentially leading to increased plasma concentrations and prolonged effects.
Reduced Efficacy Theophylline, Aminophylline These substances may reduce the sedative effects of Nitrom, leading to reduced therapeutic efficacy.

Formal Regulatory Prohibitions and Requirements:

  • Contraindicated Combinations: Co-administration with Diphenoxylate/Atropine is formally contraindicated due to the increased risk of severe CNS depression.
  • Timing Requirement: This medicine must not be taken unless the patient can ensure they will have an uninterrupted sleep of at least 7 to 8 hours to minimize the risk of anterograde amnesia and impaired alertness.
  • Population Note: Clearance is prolonged in the elderly, increasing the potential for residual effects and falls. Use is contraindicated in patients with severe hepatic insufficiency due to accumulation risk.

Mechanism of Action

Nitrom functions primarily as a specific inhibitor of the enzyme farnesyl pyrophosphate synthase (FPPS). This molecular interaction occurs by binding competitively to the active site of the enzyme, blocking the conversion of geranyl pyrophosphate (GPP) to farnesyl pyrophosphate (FPP) within the mevalonate pathway. The resulting cessation of FPP synthesis initiates a cascading effect on intracellular signaling processes. A critical consequence is the decreased prenylation of regulatory proteins, particularly small GTPases such as Ras and Rho. Without appropriate prenylation, these proteins fail to anchor to the cell membrane, which prevents their activation and thereby modulates intracellular signaling cascades that regulate cellular survival and differentiation. By interfering with the necessary signaling required for osteoclast function and attachment to the bone matrix, Nitrom induces osteoclast apoptosis (programmed cell death). This targeted reduction in the number of active osteoclasts shifts the balance of bone remodeling toward the synthetic activity of osteoblasts, resulting in the preservation of mineralized bone structure by modulating the cellular processes responsible for bone resorption.

Dosage and Administration Information

Official Administration Guidelines for Nitrom (Nitrazepam)

Nitrom is administered exclusively via the oral route as a tablet or oral suspension. Its use is governed by a defined set of instructions focused on short-term application and precise timing.


Standard Dosing and Frequency

Population Starting Dose Typical Maintenance Dose Administration Timing
Adults 5 mg single dose 5 mg to 10 mg daily Once daily, immediately before bedtime
Older Adults 2.5 mg single dose Up to 5 mg daily Once daily, immediately before bedtime

The maximum recommended daily dose for adults is 10 mg. The dose for older adults and patients with known hepatic or renal impairment is typically reduced to prevent accumulation. The oral tablet can generally be taken with or without food.


Course Duration and Procedural Rules

Treatment with Nitrom is strictly limited to a maximum duration of four weeks. This timeframe includes the necessary period for reducing the dose to zero. Treatment should be as brief as possible, and extension beyond four weeks requires a re-evaluation of the patient's status.

The dose must be precisely timed to ensure the user can obtain a full 7 to 8 hours of uninterrupted sleep after ingestion. Abrupt discontinuation is not permitted; the dose must be tapered off gradually upon cessation of the course. If a nightly dose is missed, it should only be taken if sufficient sleep time remains before the planned wake-up time.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Nitrom

Evidence for Use in Insomnia and Sleep Disturbances (Hypnotic Use)

Official research describing Nitrom's clinical evaluation has included short-term randomized controlled trials (RCTs). These trials were used in research exploring short-term or episodic symptom patterns and applied in studies examining patient-reported experiences. Researchers monitored objective sleep parameters, such as the time it takes to fall asleep (sleep onset latency) and the Total Sleep Time (TST), and also assessed subjective sleep quality.

Research reports highlight that follow-up durations were limited in most randomized studies, typically focusing on short intervals of seven to fourteen consecutive nights. Because of this limited focus, long-term effects are not fully established, and data for understanding how the effects may change with continuous, long-term use remains insufficient.

Evidence for Use in Epilepsy and Seizure Management

Research has also evaluated Nitrom in the context of specific forms of epilepsy, exploring its anticonvulsant properties. The evidence base includes a mix of comparative RCTs (where other active treatments served as a reference) and observational cohort studies. This research examined outcomes describing episodic or acute changes, primarily focusing on outcomes related to the frequency of specific seizure types, such as myoclonic spasms, particularly in infants and children with difficult-to-treat epilepsy syndromes.

A key limitation noted in this area of research is that the sample sizes were modest in many specialized studies. Follow-up durations were limited when assessing sustained activity, and data show patterns related to the development of pharmacological tolerance, a factor often noted in the regulatory evidence record.

What is Still Uncertain About Nitrom: Research Gaps and Limitations

Overall, long-term effects are not fully established for either indication. The limited follow-up durations in key randomized trials mean that data regarding the durability of any observed response over many months or years is sparse. Furthermore, comparative evidence is lacking in some areas, and data for certain groups remain insufficient across special populations.

Key Studies & References

  1. Meta-analysis of benzodiazepine use in the treatment of insomnia
  2. Long-term use of benzodiazepines in chronic insomnia: a European perspective - Frontiers
  3. comparison of effectiveness and safety of nitrazepam versus topiramate in resistant infantile epileptic spasms syndrome: an open-label, randomized controlled trial (NitRIS trial abstract)

Frequently Asked Questions (FAQ)

Common questions about Nitrom (FAQ)


Q: How quickly does Nitrom usually start working?

Official product information indicates that the active ingredient, Nitrazepam, is typically described as acting in approximately 30 to 60 minutes after being taken to produce sleep, as described in studies. The timing may vary from person to person.


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

The active ingredient's action is generally described in official sources as producing sleep that lasts for 6 to 8 hours. The medicine is generally recommended for use only when a person can ensure a necessary period of uninterrupted rest.


Q: Is Nitrom considered safe for long-term use?

According to regulatory documents, treatment with this medicine is typically limited to a maximum of four weeks, which includes the time needed to gradually stop using it. Official guidance indicates that data on the long-term effects of this drug class are often limited or insufficient.


Q: Can Nitrom cause sleepiness or affect my ability to drive?

Yes, official warnings state that this medicine can cause drowsiness and a reduction in alertness and performance. Because of these effects, the official product information specifically notes that a person's ability to drive or operate machinery may be impaired.


Q: Are there any special considerations for older adults taking Nitrom?

Yes, regulatory documents indicate that older adults require special supervision and a reduced starting dose. This population is noted to have an increased sensitivity to effects like confusion, and an elevated risk of falls and fractures has been reported.


Q: Are there any known withdrawal symptoms if Nitrom is stopped?

Official documents note the potential for a withdrawal phenomenon if the medicine is stopped abruptly. Reported symptoms following cessation can include headaches, extreme anxiety, tension, restlessness, and changes in mood. If the medicine is to be stopped, regulatory guidance emphasizes that the dosage should be reduced gradually, as directed by a healthcare professional.


Q: Does Nitrom have potential for drug abuse?

As a member of the benzodiazepine class, official warnings are in place regarding the potential risks of abuse, misuse, and addiction. The risk of dependence is noted in official warnings to increase with higher doses or prolonged duration of use.


Q: Does Nitrom have a Black Box Warning from the FDA or similar agency?

Yes. The class of medicines that Nitrom belongs to carries a Boxed Warning from the FDA regarding the serious risks of use with opioids, and the risks of addiction and dependence.


Q: What happens if I take more Nitrom than prescribed?

Symptoms described in regulatory documents following the ingestion of more than the recommended amount may include signs of overdose. These range from drowsiness and confusion in mild cases to low blood pressure, difficulty breathing, or coma in severe cases.


Q: Is Nitrom suitable for use by children or teenagers?

Regulatory documents state that use of this medicine as a hypnotic is contraindicated in children. However, in certain regulated jurisdictions, the medicine is officially indicated for the management of specific seizure types, such as myoclonic seizures.


Q: Are there different brand names or generic versions of Nitrom available?

The active ingredient in Nitrom is Nitrazepam. It is sold under various brand names, such as Mogadon, in different countries globally, in addition to being available in generic form.


Q: Is Nitrom used for purposes other than what is stated in the core information?

Official indications for this medicine include the management of short-term sleep problems (insomnia) and, in some jurisdictions, its use for specific seizure types. Any other application would not be a part of the officially approved uses.


Q: Does Nitrom cause weight gain or weight loss?

Weight change is not generally listed as a common side effect of the medicine during use. However, some sources occasionally note that weight loss is a symptom that can be experienced during the withdrawal period after the medicine is stopped.


Q: Will Nitrom cure my condition, or only manage the symptoms?

The medicine functions as a sedative-hypnotic and anticonvulsant. Its general therapeutic purpose is to manage or address symptoms—such as promoting sleep or reducing seizure frequency—rather than offering a definitive cure for the underlying condition.


Q: Will Nitrom affect my ability to get pregnant or have children?

Regulatory information advises against using this medicine during both pregnancy and breastfeeding. Preclinical research has examined the potential for the drug class to interfere with reproductive processes, and caution is advised.


Q: What kind of studies or research has been done on Nitrom?

Research supporting the medicine's use includes short-term randomized controlled trials (RCTs). These studies have primarily examined objective measures of sleep, such as the time it takes people to fall asleep (sleep onset latency) and the total time spent sleeping.


Q: What are the signs that Nitrom may not be working for me?

A loss of effect, known as tolerance, may develop after repeated use for a few weeks, which is a pattern noted in regulatory documentation.


Q: Does Nitrom affect laboratory test results?

Due to rare reports of blood disorders associated with this class of medicine, certain health authorities recommend periodic blood counts for people taking the drug. This is a precautionary measure and not a common occurrence.


Q: Does Nitrom have a metallic or strange taste?

While not a common side effect during use, some sources note that a sore tongue or a metallic taste has occasionally been reported by people experiencing the withdrawal period after the medicine is stopped.


Q: Does taking Nitrom with food affect how well it is absorbed?

Official administration guidelines indicate that the oral tablet is generally described as being able to be taken with or without food.

How should Nitrom be stored and disposed of?

Nitrom (nitroglycerin) stability is essential for its effectiveness. Sublingual tablets must be stored in their original amber glass bottle with the metal cap tightly closed. This prevents the medication from losing potency due to light, moisture, or evaporation. Do not transfer the tablets to a pillbox or cotton-stuffed container. Store at room temperature (20°C to 25°C or 68°F to 77°F) and keep it out of reach of children and pets.

Action Storage Condition Disposal Method
Storage Original, tightly capped amber glass bottle Consult drug take-back programs or flush immediately if on the FDA flush list.
Temperature Room temperature, protected from light and heat Alternatively, mix with an undesirable substance (e.g., kitty litter), seal in a bag, and discard in the household trash.

Tablets may lose potency over time; discard any unused medication after the expiration date or as instructed by your pharmacist, which may be three to five months after opening the bottle. Proper disposal protects both people and the environment.

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

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