Nomefren (Nitrazepam)

Nitrazepam is indicated for several central nervous system conditions where enhanced GABAergic inhibition is therapeutic.

• Insomnia: helps initiate and maintain sleep in patients with difficulty falling asleep or frequent awakenings.
• Anxiety disorders: reduces excessive worry and tension in generalized anxiety and related conditions.
• Seizure disorders: provides adjunctive control of certain focal and generalized seizures.

• Nitrazepam acts as a positive allosteric modulator at the GABA_A receptor complex. By binding to the benzodiazepine site, it increases the frequency of chloride channel opening in response to GABA, enhancing inhibitory neurotransmission and producing sedative, anxiolytic, muscle‑relaxant and anticonvulsant effects. This potentiation leads to a net reduction in neuronal excitability, which underlies its therapeutic actions in sleep induction, anxiety reduction, and seizure suppression.

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

Common Side Effects

• Drowsiness: feeling of sleepiness during daytime.
• Fatigue: reduced energy levels.
• Dizziness: sensation of light‑headedness.
• Impaired coordination: clumsiness or unsteady movements.
• Memory impairment: difficulty recalling recent events.
• 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 anaphylaxis.
• Depression or suicidal thoughts: mood changes requiring immediate attention.
• Paradoxical reactions: increased agitation, aggression, or anxiety.
• Dependence and withdrawal: physical dependence with abrupt discontinuation.

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

• Assess medical history: evaluate for respiratory disorders, liver impairment, or history of substance abuse.
• Avoid abrupt discontinuation: taper the dose gradually to prevent withdrawal symptoms.
• Use caution with CNS depressants: limit concurrent use of 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, as safety data are limited.
• Store at ambient temperature: keep tablets below 25 °C in the original container, protected from moisture and light.

Nitrazepam can interact with other medicines, altering its effects or increasing adverse reactions.

Major Interactions (Avoid)

• Opioids: combined CNS depression may cause profound respiratory depression.
• Barbiturates: additive sedative effects increase risk of overdose.
• Antifungal azoles (e.g., ketoconazole): may raise nitrazepam plasma levels.

Moderate Interactions (Monitor Closely)

• Antidepressants (SSRIs, SNRIs): may enhance sedation or affect serotonin balance.
• Antihistamines: increased drowsiness.
• Anticonvulsants (phenytoin, carbamazepine): may reduce nitrazepam efficacy.
• Oral contraceptives: may alter hormone levels, requiring monitoring.