Product image of Nitrazepam Accord (Nitrazepam) supplied by GNH India

Nitrazepam Accord

Active Ingredient:
Nitrazepam
Origin:
EU

Nitrazepam Accord (Nitrazepam)

Nitrazepam, the active ingredient in Nitrazepam Accord, is a benzodiazepine presented as an oral tablet for oral use. It is prescribed for the short‑term management of insomnia and for anxiety disorders in adult patients. Its pharmacological action enhances GABA‑mediated inhibition, producing sedative and anxiolytic effects.

GNH India supplies Nitrazepam Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Accord Healthcare B.V.

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Indications & Clinical Uses

Nitrazepam is used in the central nervous system to treat conditions that benefit from its sedative and anxiolytic properties.

  • Insomnia: helps initiate and maintain sleep in patients with short‑term sleep disturbances.
  • Anxiety disorders: reduces excessive worry and tension in generalized anxiety.
  • Pre‑operative anxiety: provides a calming effect before surgical procedures.

How It Works

  • Nitrazepam binds to a specific site on the GABA‑A receptor complex, acting as a positive allosteric modulator. This increases the frequency of chloride channel opening in response to GABA, enhancing neuronal inhibition and producing sedation, anxiolysis, muscle relaxation, and anticonvulsant effects.

Side Effects

Nitrazepam may cause a range of adverse reactions, which are grouped by frequency.

Common Side Effects

  • Drowsiness: feeling unusually sleepy during the day.
  • Dizziness: sensation of light‑headedness or unsteadiness.
  • Fatigue: reduced energy and motivation.
  • Impaired coordination: difficulty with fine motor tasks.
  • Memory impairment: short‑term recall difficulties.
  • Headache: mild to moderate head pain.

Serious or Rare Side Effects

  • Depression or suicidal thoughts: mood changes requiring immediate attention.
  • Respiratory depression: slowed breathing, especially with other depressants.
  • Severe skin reactions: rash, Stevens‑Johnson syndrome.
  • Anaphylaxis: acute allergic response with swelling and difficulty breathing.
  • Paradoxical reactions: agitation, aggression, or increased anxiety.

Precautions & Warnings

When prescribing nitrazepam, clinicians should consider several safety precautions to minimize risk.

  • Assess renal and hepatic function: adjust use in patients with impairment.
  • Avoid abrupt discontinuation: taper dose to prevent withdrawal symptoms.
  • Use caution in elderly: increased sensitivity to sedation and falls.
  • Avoid alcohol and other CNS depressants: risk of excessive sedation.
  • Monitor for dependence and abuse: limit duration of therapy.
  • Store at room temperature: keep in original packaging, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • CNS depressants (e.g., barbiturates, opioids): additive sedation and respiratory depression.
  • Alcohol: markedly increased drowsiness and impaired coordination.
  • Antifungal agents (e.g., ketoconazole): may raise nitrazepam plasma concentrations.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., erythromycin): possible increase in nitrazepam levels.
  • CYP3A4 inducers (e.g., carbamazepine): may reduce therapeutic effect.
  • Antidepressants (e.g., SSRIs): can enhance central nervous system depression.

Frequently Asked Questions

Nitrazepam Accord contains nitrazepam, a benzodiazepine indicated for the short‑term treatment of insomnia and for the relief of anxiety disorders. It may also be used to calm patients before surgical procedures when a rapid anxiolytic effect is required.

Nitrazepam acts as a positive allosteric modulator at the GABA‑A receptor. By binding to a specific site, it increases the frequency of chloride channel opening when GABA binds, enhancing inhibitory neurotransmission and producing sedative, anxiolytic, muscle‑relaxant, and anticonvulsant effects.

The prescribed dose of nitrazepam is individualized by the treating clinician based on the patient’s age, clinical condition, response, and any comorbidities. Healthcare professionals determine the appropriate strength and dosing schedule, which may differ for insomnia versus anxiety management.

Safety data for nitrazepam in pregnancy and lactation are limited, and the medication is generally avoided unless the potential benefit outweighs the risk. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To order Nitrazepam Accord, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details, and any necessary import documentation.

Nitrazepam shares the core mechanism of GABA‑A modulation with other benzodiazepines but is distinguished by a relatively long half‑life, which can provide sustained sleep promotion. Compared with shorter‑acting agents, it may have a higher risk of next‑day sedation, making patient selection and dosing duration important considerations.

Nitrazepam Accord should be stored at room temperature, below 25 °C. Keep the tablets in the original blister pack or container, protect them from moisture and direct sunlight, and ensure they are out of reach of children.

Nitrazepam Accord is administered orally as a tablet. The tablet should be swallowed whole with a glass of water, preferably at bedtime for insomnia or as directed by a physician for anxiety. It should not be crushed, chewed, or divided unless specifically advised.

Serious risks include severe depression or suicidal thoughts, respiratory depression especially when combined with other depressants, paradoxical reactions such as agitation, and rare but severe skin reactions. Patients should seek immediate medical attention if they experience any of these symptoms.

Nitrazepam is contraindicated in individuals with known hypersensitivity to benzodiazepines, severe respiratory insufficiency, acute narrow‑angle glaucoma, and in patients with a history of severe hepatic impairment. Caution is also advised for the elderly, pregnant or nursing women, and those with a history of substance dependence.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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