Product image of Nitredon (Nitrazepam) supplied by GNH India

Nitredon

Active Ingredient:
Nitrazepam
Origin:
EU

Nitredon (Nitrazepam)

Nitrazepam, the active ingredient in Nitredon, is a benzodiazepine presented as a tablet for oral use. It acts on the central nervous system to produce a calming effect and is commonly prescribed for short‑term management of insomnia, various anxiety disorders, and as a pre‑operative sedative in adult patients.

GNH India supplies Nitredon as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, globally ensuring consistent product quality through rigorous quality‑assurance procedures and adherence to EU regulatory standards.

Manufacturer / TM Owner

Remedica Ltd

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Indications & Clinical Uses

Nitrazepam is a benzodiazepine that modulates the GABA‑A receptor pathway, providing therapeutic effects in several central nervous system conditions.

  • Insomnia: helps initiate and maintain sleep, reducing nighttime awakenings.
  • Anxiety disorders: alleviates excessive worry and tension, promoting calmness.
  • Preoperative sedation: provides calming and amnesic effects before surgical procedures.

How It Works

  • Nitrazepam binds to an allosteric site on the GABA‑A receptor complex, enhancing the affinity of the receptor for the inhibitory neurotransmitter gamma‑aminobutyric acid (GABA). This positive allosteric modulation increases chloride ion influx into neurons, hyperpolarising the cell membrane and reducing neuronal excitability, which produces sedative, anxiolytic, muscle‑relaxant and anticonvulsant effects. The enhanced GABAergic transmission leads to a generalized depressant effect on the central nervous system, accounting for its clinical utility in sleep induction and anxiety reduction.

Side Effects

Nitrazepam may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Drowsiness: feeling of sleepiness during daytime.
  • Dizziness: light‑headed sensation or loss of balance.
  • Fatigue: reduced energy and increased tiredness.
  • Impaired coordination: clumsiness or difficulty with fine motor tasks.
  • Memory disturbances: short‑term recall problems.
  • Headache: mild to moderate head pain.

Serious or Rare Side Effects

  • Respiratory depression: slowed or shallow breathing, especially with other depressants.
  • Severe allergic reaction: rash, itching, swelling, or difficulty breathing.
  • Paradoxical agitation: increased anxiety, aggression, or hostility.
  • Dependence and withdrawal: physical or psychological reliance with abrupt discontinuation.
  • Mood changes: depression or suicidal thoughts.
  • Hepatic dysfunction: abnormal liver enzymes or jaundice.

Precautions & Warnings

When prescribing Nitrazepam, clinicians should consider several safety precautions to minimise risk.

  • Assess medical history: evaluate for respiratory disorders, hepatic impairment, or glaucoma.
  • Avoid abrupt discontinuation: taper dose gradually to prevent withdrawal symptoms.
  • Use caution with CNS depressants: limit concurrent alcohol, opioids, or other sedatives.
  • Monitor elderly patients: increased sensitivity may lead to falls or confusion.
  • Pregnancy and lactation: prescribe only if benefits outweigh potential risks.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture and light.

Avoid Interactions

Nitrazepam can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Opioids: combined use may cause profound respiratory depression.
  • Barbiturates: additive CNS depression can increase sedation and risk of overdose.
  • Antifungal azoles (e.g., ketoconazole): may raise nitrazepam plasma levels, enhancing toxicity.
  • Macrolide antibiotics (e.g., erythromycin): can inhibit metabolism, leading to accumulation.
  • CNS depressants (e.g., antihistamines, muscle relaxants): heightened sedative effects.

Moderate Interactions (Monitor Closely)

  • Antidepressants (SSRIs, SNRIs): may increase risk of serotonin syndrome or enhanced sedation.
  • Anticonvulsants (phenytoin, carbamazepine): may reduce nitrazepam effectiveness.
  • Herbal supplements (St. John’s wort): may induce metabolism, lowering drug concentration.
  • Diuretics: may exacerbate electrolyte imbalances, affecting CNS stability.
  • Caffeine: can counteract sedative effect, requiring dose adjustment.

Frequently Asked Questions

Nitredon contains nitrazepam, a benzodiazepine indicated for short‑term treatment of insomnia, for the relief of anxiety disorders, and as a pre‑operative sedative to calm patients before surgical procedures. It is prescribed for adult patients when a rapid onset of calming effect is required.

Nitrazepam binds to a specific allosteric site on the GABA‑A receptor complex, increasing the receptor’s affinity for the inhibitory neurotransmitter GABA. This enhances chloride ion influx, hyperpolarising neuronal membranes and reducing neuronal firing, which produces sedative, anxiolytic, muscle‑relaxant and anticonvulsant actions.

The appropriate dose of Nitredon is determined by the prescribing clinician based on the individual’s medical condition, age, response to therapy and any concomitant medications. Dosage regimens are not standardized in public literature and should be followed exactly as written on the prescription.

Safety data for nitrazepam in pregnancy and lactation are limited. The drug is generally prescribed only when the potential benefit to the mother outweighs possible risks to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives and risk assessment with their healthcare provider.

To request Nitredon, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

Nitredon (nitrazepam) has a relatively long elimination half‑life compared with shorter‑acting agents such as temazepam. This can provide more sustained sleep promotion but may increase residual daytime sedation. Choice of benzodiazepine depends on the clinical scenario, desired duration of action, patient age, and risk of accumulation.

Nitredon tablets should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and ensure the container is tightly closed to maintain stability throughout its shelf life.

Nitredon is supplied as oral tablets that are taken by mouth with a glass of water. The tablet should be swallowed whole and not crushed or chewed unless otherwise directed by a healthcare professional.

Serious risks include respiratory depression, especially when combined with other central nervous system depressants, severe allergic reactions, paradoxical agitation, dependence and withdrawal syndrome upon abrupt discontinuation, and rare hepatic dysfunction. Patients should be monitored closely for these events, particularly during the initiation of therapy.

Nitredon is contraindicated in individuals with known hypersensitivity to nitrazepam or other benzodiazepines, patients with severe respiratory insufficiency, acute narrow‑angle glaucoma, and those who are currently intoxicated with alcohol or other CNS depressants. Caution is also advised for patients with severe hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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