Нитразепам

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Нитразепам

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Treatment option: Insomnia, Sedation

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 Нитразепам

What is Нитразепам? (Nitrazepam)

Property Description
Active ingredient Nitrazepam
Form Tablet (Oral)
Pharmacological class Benzodiazepine derivative, CNS depressant
General purpose Sedation, Hypnosis, Anticonvulsion
Origin Synthetic

What Type of Medicine is Нитразепам?

Нитразепам (Nitrazepam) is a synthetic pharmaceutical substance classified as a benzodiazepine derivative and a powerful Central Nervous System (CNS) depressant. The medication's sole active component is the compound Nitrazepam, which is chemically recognized as a nitrobenzodiazepine, a specific sub-group of the larger benzodiazepine class. This single-ingredient product is categorized pharmacologically as a Psycholeptic due to its profound influence on brain activity.

The compound is clinically recognized for its long half-life and potent ability to induce sleep, distinguishing its profile from many shorter-acting agents in the benzodiazepine family. The classification of Nitrazepam as a hypnotic agent is well-established in global regulatory documents and supported by pharmacological studies.

What is the General Purpose of Nitrazepam?

The general purpose of Nitrazepam is to induce profound sedative and hypnotic effects by significantly quieting overactive neural signals in the brain. This action promotes deep sedation and helps initiate and sustain sleep, making it generally helpful for alleviating severe disturbances in sleep patterns, such as chronic difficulty falling asleep or frequent nocturnal awakenings. As a strong anticonvulsant and effective skeletal muscle relaxant, the compound is also leveraged to inhibit and manage abnormal, excessive electrical discharges in the nervous system. The overall utility of the drug stems from its capacity to dampen excitability.

In What Form is Нитразепам Supplied?

Нитразепам is manufactured and supplied primarily in the tablet dosage form, which is designed for oral administration and provides a standardized delivery of the active component. This solid oral preparation functions strictly as a single-ingredient product, meaning all therapeutic activity is attributable solely to the Nitrazepam compound, compounded with solid excipients that form the inert vehicle of the tablet.

What side effects are possible with Нитразепам?

Possible Side Effects and Safety Information

The safety profile of Nitrazepam is primarily defined by effects stemming from its action as a Central Nervous System (CNS) depressant. Adverse reactions are classified according to frequency, as documented in official regulatory documents.


Frequency-Classified Adverse Reactions

Classification Representative Effects (System-Organ Class)
Common Drowsiness, reduced alertness, fatigue, ataxia (unsteadiness), muscle weakness, diplopia (double vision), confusional state (Nervous/Psychiatric System Disorders). These effects are often more pronounced at the beginning of treatment and may lessen with continued use.
Rare Anterograde amnesia (dose-related), hypotension, nausea, abdominal discomfort, urinary retention, skin rashes.
Frequency Not Known Serious reactions including respiratory depression, severe cutaneous reactions (e.g., Stevens-Johnson syndrome), jaundice, and severe withdrawal syndrome following cessation.

Clinically Significant Safety Considerations

The label documents several serious safety constraints. Respiratory depression, coma, and death are noted as risks, particularly when Nitrazepam is used concurrently with Opioids or other potent CNS depressants. The risk of developing physical and psychological dependence and subsequent withdrawal symptoms increases with the duration and dosage of use.

Special safety considerations are documented for specific populations. Older adults are noted to have increased sensitivity to the depressant effects, leading to a higher risk of falls and hip fractures. Furthermore, Nitrazepam is contraindicated in cases of severe respiratory insufficiency (e.g., significant sleep apnea) and severe hepatic insufficiency.

Overdose and Emergency Response

Overdose with Nitrazepam, a Central Nervous System (CNS) depressant, presents as an exaggeration of its expected effects. Documented clinical manifestations typically begin with somnolence (profound drowsiness), confusion, slurred speech, and a loss of coordination (ataxia).

The overdose profile classifies serious outcomes tied to severe CNS depression. This can rapidly progress to coma, respiratory depression, and, in the most severe cases, respiratory arrest or death. This critical risk is significantly heightened by the concomitant ingestion of alcohol or opioids. Official warnings note that older people face an increased susceptibility to these severe respiratory and CNS effects.

Immediate medical help must be sought if any signs of severe toxicity are observed, such as profoundly slowed or shallow breathing, difficulty rousing the person, or a complete loss of consciousness.

Management focuses on supportive care to maintain vital functions, including airway and hemodynamic stability. Although a specific antagonist (Flumazenil) exists to potentially reverse the effects, close hospital monitoring is required for all patients due to the risk of re-sedation and other complications.

Therapeutic Uses of Нитразепам

What Нитразепам treats: Main Uses and Benefits

Nitrazepam is considered relevant for easing certain distressing symptoms across key therapeutic domains. This medication is generally used to help with symptomatic relief rather than curing underlying conditions.

The medication is relevant for managing symptom clusters that may become intense or disruptive, specifically in conditions characterized by periods of heightened symptoms. It is commonly used to help with the management of severe, debilitating insomnia that involves prolonged difficulty falling asleep or frequent nocturnal awakenings. It is also relevant for managing symptoms of certain seizure disorders, particularly specific forms of myoclonic seizures and infantile spasms. The therapeutic focus is on providing supportive relief in scenarios where temporary assistance in symptom stabilization is important.

“The medication may assist with maintaining a sense of stability when symptoms are more noticeable, supporting the patient during difficult episodes.”

Quick Fact: Support for Symptoms Related to Hyper-Arousal

Nitrazepam is also relevant for easing symptoms related to heightened physiological activity, such as pronounced nervous tension and generalized restlessness, which can interfere with daily functioning. It is applied during phases of increased distress or discomfort, providing support that helps ease the overall symptom burden.

Regulatory References

  1. UK's official therapeutic information

Eligibility and Restrictions for Use

Who Can and Cannot Use Nitrazepam

The eligibility for Nitrazepam (Нитразепам) is strictly defined by regulatory authorities based on age, specific medical conditions, and physiological status.


Contraindicated Populations

The medication must not be used by patients with a known hypersensitivity to benzodiazepines, or those diagnosed with myasthenia gravis, severe hepatic insufficiency, severe respiratory insufficiency, or sleep apnoea syndrome. It is also contraindicated for use as a hypnotic in children, and should not be used as the sole treatment for depression or chronic psychosis.

Eligibility Restrictions

Category Regulatory Status Restrictions
Age (Adults) Allowed Approved for short-term, severe insomnia.
Age (Children) Contraindicated Prohibited for use as a hypnotic/for insomnia.
Age (Elderly) Special Caution Dosage must be significantly reduced.
Pregnancy/Lactation Not Recommended Use should be avoided, especially during the first and last trimesters.
Organ Function Special Caution Patients with chronic renal or non-severe hepatic disease may require a reduced dose.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The officially documented interactions for Nitrazepam are generally classified into two main categories: pharmacodynamic reinforcement and pharmacokinetic alteration of clearance. All statements below are based on government regulatory labeling.

Pharmacodynamic Interactions (Additive CNS Depression)

Co-administration with other substances that also depress the Central Nervous System (CNS) may result in an additive or synergistic effect, leading to an increased risk of severe CNS depression. Product categories officially linked to this risk include Opioid analgesics, Antipsychotics, Hypnotics, Sedative Antihistamines, Anaesthetics, and Antidepressants. Official documentation strictly advises that alcohol (ethanol) must be avoided due to its potentiation of this depressant effect.

Pharmacokinetic Interactions (Increased Exposure)

Specific medicines are documented to interfere with Nitrazepam's removal from the body, leading to an increase in plasma concentration and greater exposure. For example, Cimetidine is formally recorded as an agent that impairs the clearance of Nitrazepam, which prolongs its presence and action in the body. Other medicines that inhibit hepatic enzymes may also increase the concentration and enhance the activity of Nitrazepam.

Population-Specific Notes

Interaction effects are noted to be more pronounced in the elderly population. Additionally, patients with existing hepatic impairment may have a heightened risk associated with interactions that further impede the drug's metabolism.

Mechanism of Action

Enhancement of Central Inhibitory Signaling

Нитразепам acts as a Positive Allosteric Modulator (PAM) of the GABA A receptor ( GABA A R) complex in the central nervous system (CNS). It binds to the allosteric benzodiazepine site, primarily located at the interface of the alpha and gamma subunits. This interaction enhances the effect of the endogenous neurotransmitter, GABA, on the receptor. The primary action is an increase in the frequency of the GABA A R channel opening, not the duration of its opening.


Molecular Cascade Leading to Neuronal Hyperpolarization

Increased channel opening permits a greater influx of negatively charged chloride ions ( Cl^-) into the postsynaptic neuron. This Cl^- influx causes the neuron to become more negatively charged, a process known as hyperpolarization. Hyperpolarization stabilizes the neuronal membrane and reduces the cell's excitability. This molecular cascade reduces the propagation of high-frequency excitatory signals across the CNS, which results in a generalized CNS depressant effect and the physiological basis for reduced motor reflex excitability and neuronal hyperexcitability.

Dosage and Administration Information

The administration of Nitrazepam is restricted to the oral route using its tablet formulation. General administration guidelines define the specific dosage, frequency, and duration limits for the medicine’s use, which is based on its classification as a hypnotic.

Dosing and Administration Protocol

For adult use, the starting dose is generally 5 mg, which may be increased to a maximum of 10 mg once daily. The drug is taken at night, immediately before retiring for bed. This timing is utilized to ensure that the user is able to guarantee a subsequent, uninterrupted sleep period of seven to eight hours.

A critical principle of use is the short-term duration for insomnia treatment, which is limited to a maximum of four weeks. This time restriction, which includes the necessary period for gradual dose reduction, governs the overall use protocol and is not to be extended without re-evaluation. Long-term continuous use is not recommended.

Standard protocols also include specific dose reductions for sensitive populations. Older adults, as well as patients with chronic hepatic or renal impairment, are typically initiated on a lower daily dose, ranging from 2.5 mg to 5 mg, to account for altered drug processing and sensitivity. The tablets are designed to be swallowed whole with water and do not require prior preparation.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Нитразепам (Nitrazepam)


Evidence for use in Short-term Insomnia

Research was studied for its use in trials applied in studies examining patient-reported experiences related to temporary sleep disturbances, including difficulty falling asleep or frequent awakenings. These studies monitored outcomes reflecting daily functioning or activity level, alongside patient-reported outcomes describing perceived discomfort linked to poor sleep. These trials primarily research examined how symptoms evolved in the observed populations over a limited time frame, typically a few weeks.

The findings describe patterns observed in the studies where participants reported outcomes were short-term related to sleep onset and duration. Data show patterns related to temporary changes measured during the study period. However, these studies focusing on episodes where symptoms become more noticeable were generally small and limited in duration.


Evidence for use in Myoclonic Seizures (Epilepsy)

Nitrazepam was evaluated in the context of research exploring specific conditions characterized by episodic or acute changes, such as certain seizure syndromes. Research in this area often involved observational settings evaluating daily-life functioning and applied in research contexts involving fluctuating or unstable symptoms, such as infantile spasms (West syndrome).

Studies explored how the frequency of these episodic or acute changes was monitored during defined time intervals. Research describing temporary physiological imbalance reported observations of nitrazepam use during periods of increased symptom activity in conditions characterized by fluctuating or episodic manifestations. However, evidence is limited primarily to older, uncontrolled studies, or smaller cohorts.


Long-term Studies and Follow-up

Research has explored extended-duration exposure to nitrazepam, mainly through observational studies rather than controlled, multi-year trials. These studies monitored outcomes related to systemic or functional imbalance over extended periods. This evidence contributes to the broader evidence landscape by providing data points on extended exposure, but the evidence quality varies across studies.


What is Still Uncertain About Нитразепам Research

Research is ongoing but several key gaps remain in the evidence base for nitrazepam. Evidence quality varies across studies, with many foundational reports being older and lacking modern methodological rigor. Findings were mixed or inconsistent across some of the smaller cohorts and observational settings, making interpretation more complex. Long-term effects are not fully established, as follow-up durations were limited in many of the core trials.

Key Studies & References Meta-analysis of benzodiazepine use in the treatment of insomnia - CMAJ

Frequently Asked Questions (FAQ)

Common questions about Нитразепам (FAQ)


Q: Is Нитразепам considered a sleeping pill or an anti-anxiety drug?

Official product information classifies Nitrazepam primarily as a hypnotic (a sleep inducer) for treating severe insomnia. As a benzodiazepine, it also possesses strong sedative properties, which describe its action of calming the central nervous system.


Q: What is the half-life of Нитразепам?

Studies and official information indicate that Nitrazepam has a long half-life, meaning the substance remains in the body for an extended period. The elimination half-life typically ranges from approximately 15 to 38 hours in younger adults, and this duration may be longer in older patients.


Q: Can Нитразепам be taken at the same time as common over-the-counter pain relievers?

Caution is required when combining Nitrazepam with any medicine that has a Central Nervous System (CNS) depressant effect, as this may increase the risk of adverse reactions. Official documentation stresses consultation with a healthcare professional regarding all co-administered medicines, as only specific drug classes, such as opioids, are explicitly listed as having highly contraindicated pharmacodynamic effects.


Q: Is Нитразепам a strong or weak sedative compared to other drugs?

Regulatory documents classify Nitrazepam as a powerful Central Nervous System (CNS) depressant. It is recognized for its potent ability to induce sleep, and its action is based on significantly quieting overactive neural signals in the brain.


Q: What should a patient know if they have a scheduled surgery while taking Нитразепам?

Official documents warn that use with anaesthetics carries a risk of additive CNS depression. This may lead to severe adverse effects, including respiratory problems. Official guidelines specify that individuals must ensure their medical team is aware of their use of Nitrazepam prior to any scheduled surgical procedure requiring general anaesthesia.


Q: Does the efficacy of Нитразепам decrease over time?

Regulatory documents indicate that tolerance to the drug's effects can develop, which may lead to a diminished therapeutic response. This reduction in efficacy is sometimes observed within the first 3 to 14 days of continuous use.


Q: How quickly does Нитразепам typically start to work after taking it?

The medication is rapidly absorbed, but the pharmacological effect takes time to peak in the bloodstream. Studies show that mean peak plasma concentrations (the highest level of drug in the bloodstream) are typically observed around 3 hours after oral administration.


Q: Does taking Нитразепам cause rebound insomnia?

Rebound insomnia is a recognized risk reported following the cessation of treatment. This syndrome is characterized by the temporary return of the original sleep symptoms in an enhanced form.


Q: Are there specific signs that tolerance to Нитразепам is developing?

Tolerance is a condition characterized by the drug's therapeutic effect diminishing over time. This may be noticeable if the initial response is lost and the insomnia symptoms fail to remit or return after the first 7 to 10 days of treatment.


Q: Are there any specific foods that should be avoided when taking Нитразепам?

Official product information states that Nitrazepam tablets may be taken with or without food. However, regulatory documents specify that alcohol (ethanol) must be strictly avoided due to its potentiation of the Central Nervous System (CNS) depressant effect.


Q: What is the risk of accidental overdose with Нитразепам?

Overdose involving Nitrazepam alone generally does not present a threat to life. However, the risk of severe complications, including respiratory depression, coma, and death, significantly increases when the medicine is combined with alcohol or other potent Central Nervous System (CNS) depressants (other risk factors not explicitly listed here apply).


Q: Is there a legal classification for Нитразепам in my country?

Regulatory authorities classify Nitrazepam as a controlled medicine due to its potential for dependence and misuse. Examples of these classifications include a Schedule 4 (CD Benz) substance in the UK or a Schedule IV controlled substance in the US.


Q: Why is Нитразепам known by the brand name Mogadon in some regions?

The compound Nitrazepam is historically and commonly cited in official health and controlled medicine information by the trade name Mogadon in various regions.


Q: What should I know about the potential for misuse or diversion of Нитразепам?

Regulatory documents note that Nitrazepam has a high potential for habit-forming and that abuse of benzodiazepines has been reported. For this reason, official guidelines mandate the shortest possible treatment duration.


Q: Is it normal to have vivid dreams when taking Нитразепам?

Nightmares are noted in official product information as a rare adverse behavioral effect. This can sometimes occur as part of a paradoxical reaction to the medicine, which involves effects contrary to the intended sedation.


Q: Can taking Нитразепам disrupt the natural sleep cycle (REM sleep)?

Studies and regulatory monographs indicate that Nitrazepam affects the architecture of sleep. Specifically, it can cause a delay in the onset and a decrease in the duration of REM (Rapid Eye Movement) sleep.


Q: Is it possible to feel anxious or agitated as a side effect of Нитразепам?

Yes, it is possible to experience paradoxical reactions to the medicine, which are adverse behavioral effects that run contrary to the intended sedative effect. These reactions can include restlessness, agitation, anxiety, irritability, and increased aggressiveness.


Q: What is the generic name for Нитразепам?

The generic name for the active ingredient is simply Nitrazepam. This name is used to identify the chemical compound across all marketed products.


Q: Is Nitrazepam sometimes used for purposes other than insomnia?

Yes, in addition to its use as a hypnotic for insomnia, regulatory documents recognize its function as a strong anticonvulsant (anti-seizure) and an effective skeletal muscle relaxant.

How should Нитразепам be stored and disposed of?

How to Store and Dispose of Nitrazepam?

  • Storage: Nitrazepam tablets should be stored at controlled room temperature, typically between 15 C and 30 C (59 F and 86 F). The medicine must be kept in a dry place, away from excessive heat, moisture, and direct light, and out of the sight and reach of children. Liquid formulations may require refrigeration; consult the specific product labeling for accurate instructions.
  • Disposal: Due to its potential for abuse and harm, unused or expired Nitrazepam should be disposed of promptly and safely. The preferred method is to drop off the medication at a community drug take-back location or use a mail-back program. If these options are not readily available, some national guidelines may recommend flushing it down the toilet to prevent accidental ingestion, but only if it is on the authorized flush list. Otherwise, mix it with an undesirable substance (like coffee grounds or dirt) and place it in a sealed container before discarding it in the household trash. Always scratch out personal information on the prescription label.

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

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