{"id":7952,"date":"2026-04-21T13:15:46","date_gmt":"2026-04-21T13:15:46","guid":{"rendered":"https:\/\/bristishpharmacy.co.uk\/?post_type=product&p=7952"},"modified":"2026-09-16T11:10:50","modified_gmt":"2026-09-16T11:10:50","slug":"nitrazepam-5-mg","status":"publish","type":"product","link":"https:\/\/bristishpharmacy.co.uk\/de\/shop\/nitrazepam-5-mg\/","title":{"rendered":"Nitrazepam 5 mg"},"content":{"rendered":"

\u00a0<\/h1>\n
\n
\n

Clinical Monograph: Nitrazepam 5 mg<\/h3>\n

1. Classification and Chemical Overview<\/h2>\n

Nitrazepam is a chlorinated nitrobenzodiazepine derivative chemically designated as 1,3-dihydro-7-nitro-5-phenyl-2H<\/i>-1,4-benzodiazepin-2-one. Under the Anatomical Therapeutic Chemical (ATC) system, nitrazepam is indexed under N05CD02.<\/p>\n

The 5 mg strength represents a standard adult therapeutic dose for insomnia management. Internationally, nitrazepam is classified as a Controlled Substance (Schedule IV under the US Controlled Substances Act; Schedule 3 \/ Class C Controlled Drug in the UK) due to its risks of tolerance, physical dependence, and misuse. It is regulated strictly as a Prescription Only Medicine (POM).<\/p>\n

2. Mechanism of Action and Pharmacodynamics<\/h2>\n

Nitrazepam produces hypnotic, sedative, anxiolytic, and skeletal muscle relaxant properties via allosteric modulation of central nervous system receptors:<\/p>\n

    \n
  • \n

    FRONT<\/span>A<\/span><\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span> Receptor Potentiation:<\/b> Binds with high affinity to the benzodiazepine binding site located on the FRONT<\/span>A<\/span><\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span> receptor complex.<\/p>\n<\/li>\n

  • \n

    Chloride Conductance Enhancement:<\/b> Facilitates GABA-mediated opening of chloride ion channels, hyperpolarizing the neuronal membrane and suppressing electrical excitability across sleep-promoting centers in the brainstem and limbic system.<\/p>\n<\/li>\n

  • \n

    Sleep Architecture Alteration:<\/b> Decreases sleep latency, reduces nocturnal awakenings, and prolongs total sleep duration, though prolonged use can alter normal sleep architecture (e.g., reducing REM sleep).<\/p>\n<\/li>\n<\/ul>\n

    3. Approved Clinical Indications and Dosing Scope<\/h2>\n

    Licensing for nitrazepam includes:<\/p>\n

      \n
    • \n

      Severe Insomnia:<\/b> Short-term management of severe, disabling insomnia that is causing profound distress or exhaustion in adults.<\/p>\n<\/li>\n<\/ul>\n

      Dosing & Administration Regimen:<\/i><\/p>\n

        \n
      • \n

        Adult Dosage:<\/b> Typically 5 mg to 10 mg taken orally immediately before bedtime. In elderly or debilitated patients, initial dosing should not exceed 5 mg due to heightened sensitivity and risks of excessive sedation or ataxia.<\/p>\n<\/li>\n

      • \n

        Duration Restrictions:<\/b> Treatment duration should be kept to the absolute minimum (typically not exceeding 2 weeks) to minimize the risk of dependence and tolerance.<\/p>\n<\/li>\n<\/ul>\n

        4. Pharmacokinetic Profile and Metabolic Fate<\/h2>\n
          \n
        • \n

          Absorption:<\/b> Readily absorbed from the gastrointestinal tract, with peak plasma concentrations (C<\/span>ma<\/span>x<\/span><\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span>) attained within 2 hours (T<\/span>ma<\/span>x<\/span><\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span>).<\/p>\n<\/li>\n

        • \n

          Distribution:<\/b> Highly lipophilic with extensive tissue distribution; plasma protein binding is approximately 85% to 88%. Crosses the blood-brain barrier, placenta, and enters human breast milk.<\/p>\n<\/li>\n

        • \n

          Biotransformation:<\/b> Extensively metabolized in the liver primarily via nitroreduction by Cytochrome P450 enzymes and subsequent acetylation to inactive amino metabolites (7-aminonitrazepam and 7-acetamidonitrazepam).<\/p>\n<\/li>\n

        • \n

          Elimination:<\/b> Excreted predominantly in urine as conjugated metabolites. Nitrazepam is a medium-to-long-acting agent with an elimination half-life (t<\/span>1\/2<\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span>) ranging from 15 to 38 hours, which can lead to next-day residual sedation (“hangover effect”).<\/p>\n<\/li>\n<\/ul>\n

          5. Physiological Effects and Adverse Event Spectrum<\/h2>\n

          Nitrazepam depresses central nervous system function, dampens psychomotor performance, and relaxes skeletal muscle tone.<\/p>\n

          Adverse Drug Reaction Spectrum<\/h3>\n
            \n
          • \n

            Very Common (\u2265<\/span><\/span>1\/10<\/span><\/span><\/span><\/span><\/span>):<\/b> Residual daytime drowsiness, daytime sedation, lightheadedness, impaired coordination, ataxia.<\/p>\n<\/li>\n

          • \n

            Common (\u2265<\/span><\/span>1\/100<\/span><\/span><\/span><\/span><\/span> to <<\/span><\/span>1\/10<\/span><\/span><\/span><\/span><\/span>):<\/b> Confusion, dizziness, headache, muscle weakness, visual disturbances, emotional lability, fatigue.<\/p>\n<\/li>\n

          • \n

            Uncommon (\u2265<\/span><\/span>1\/1<\/span>,<\/span>000<\/span><\/span><\/span><\/span><\/span> to <<\/span><\/span>1\/100<\/span><\/span><\/span><\/span><\/span>):<\/b> Paradoxical reactions (agitation, aggression, rage, irritability), anterograde amnesia, skin rash, gastrointestinal distress, changes in libido.<\/p>\n<\/li>\n

          • \n

            Rare \/ Severe (<1\/1,000):<\/b> Severe respiratory depression, blood dyscrasias (leukopenia, thrombocytopenia), severe withdrawal syndrome, hepatic dysfunction.<\/p>\n<\/li>\n<\/ul>\n

            6. Contraindications, Drug Interactions, and Clinical Precautions<\/h2>\n

            Kontraindikationen<\/h3>\n
              \n
            • \n

              Known hypersensitivity to nitrazepam or other benzodiazepines.<\/p>\n<\/li>\n

            • \n

              Severe acute respiratory insufficiency or respiratory depression.<\/p>\n<\/li>\n

            • \n

              Sleep apnea syndrome.<\/p>\n<\/li>\n

            • \n

              Myasthenia gravis.<\/p>\n<\/li>\n

            • \n

              Severe hepatic impairment.<\/p>\n<\/li>\n

            • \n

              Acute narrow-angle glaucoma.<\/p>\n<\/li>\n<\/ul>\n

              Key Drug Interactions<\/h3>\n
                \n
              • \n

                CNS Depressants, Opioids, & Alcohol:<\/b> Co-administration results in profound, synergistic central nervous system and respiratory depression, significantly elevating the risk of fatal overdose, coma, and respiratory arrest.<\/p>\n<\/li>\n

              • \n

                CYP3A4 Inhibitors & Inducers:<\/b> Inhibitors (e.g., erythromycin, ketoconazole) can reduce clearance and enhance sedation, while inducers (e.g., rifampicin, carbamazepine) accelerate metabolism and reduce efficacy.<\/p>\n<\/li>\n<\/ul>\n

                Clinical Precautions and Monitoring<\/h3>\n
                  \n
                • \n

                  Boxed Warning (Concomitant Opioid Use & Abuse\/Dependence):<\/b> Combined use with opioids increases the risk of severe respiratory depression and death. Long-term continuous use leads to physical and psychological dependence.<\/p>\n<\/li>\n

                • \n

                  Rebound Insomnia & Withdrawal:<\/b> Abrupt cessation after regular use triggers an acute withdrawal syndrome characterized by severe rebound insomnia, anxiety, tremors, sweating, and, in severe cases, convulsions. Tapering is mandatory.<\/p>\n<\/li>\n

                • \n

                  Falls Risk in Elderly:<\/b> Due to its long half-life and residual sedative effects, nitrazepam significantly increases the risk of daytime falls, confusion, and hip fractures in elderly populations; use with extreme caution.<\/p>\n<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n

                  \n\n\t\t\n
                    \n\t\t\t <\/ul>\n <\/div>","protected":false},"excerpt":{"rendered":"

                    Nitrazepam 5 mg is a medium-to-long-acting nitrobenzodiazepine sedative-hypnotic agent indicated for the short-term management of severe, disabling insomnia. It functions by potentiating central GABAergic neurotransmission to induce and maintain sleep.<\/p>\n

                    \u00a0<\/h3>","protected":false},"featured_media":7963,"comment_status":"closed","ping_status":"closed","template":"","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""}},"product_brand":[],"product_cat":[104],"product_tag":[229],"class_list":["post-7952","product","type-product","status-publish","has-post-thumbnail","product_cat-anxiety-pills","product_tag-nitrazepam-5mg","instock","shipping-taxable","purchasable","product-type-variable"],"yoast_head":"\nNitrazepam 5mg - British Pharmacy<\/title>\n<meta name=\"description\" content=\"Nitrazepam (Mogadon or Insom) is a\u00a0benzodiazepine\u00a0medication primarily used as a\u00a0hypnotic\u00a0(sleep aid) for short-term treatment of severe insomnia in adults.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bristishpharmacy.co.uk\/de\/shop\/nitrazepam-5-mg\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nitrazepam 5mg\" \/>\n<meta property=\"og:description\" content=\"Nitrazepam 5 mg is a medium-to-long-acting nitrobenzodiazepine sedative-hypnotic agent indicated for the short-term management of severe, disabling insomnia. 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