Description

Nitrazepam Tablets (5 mg / 10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced psychiatric, neurology, and restricted central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically precise Nitrazepam Uncoated / Film-Coated Tablets (5 mg / 10 mg), manufactured in WHO–GMP certified, highly secure psychotropic oral solid dosage facilities. This “Long-Acting Benzodiazepine Hypnotic” is an ultra-high-value, highly regulated export to psychiatric hospitals, severe sleep disorder clinics, neurology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, heavy-duty intervention for severe, disabling insomnia and specific myoclonic seizure disorders.

Product Overview

This highly advanced formulation contains Nitrazepam, a potent, long-acting nitrobenzodiazepine that fundamentally depresses the central nervous system, violently shutting down racing thoughts, severe anxiety, and motor agitation to force deep, sustained sleep.

The “GABA-A Allosteric Modulator & Hypnotic” Specialist:

• Mechanism 1 (The GABA-A Amplification): In patients suffering from severe insomnia, the brain’s excitatory signals completely overpower its calming signals. Nitrazepam aggressively binds to the benzodiazepine site on the GABA-A receptor in the brain. It physically alters the receptor to make it massively more sensitive to GABA (the brain’s primary inhibitory neurotransmitter). This hyperpolarizes the neurons, completely silencing the hyperactive electrical signals causing the wakefulness.
• Mechanism 2 (Sleep Architecture Modification): Nitrazepam drastically reduces “sleep latency” (the time it takes to fall asleep) and massively decreases the number of nighttime awakenings. Because it has a relatively long half-life (up to 30 hours), it guarantees that a patient suffering from extreme stress or psychiatric distress will sleep completely through the night.
• The Anticonvulsant “Off-Label” Advantage: Beyond sleep, Nitrazepam possesses profound muscle-relaxant and anticonvulsant properties. It is frequently stockpiled by pediatric neurology wards as a critical adjunct therapy for controlling severe, refractory myoclonic seizures and infantile spasms (West Syndrome).

Product Composition & Strength

We supply this product as a Precision-Blended Tablet, packed exclusively in highly secure, tamper-evident Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the active ingredient and prevent unauthorized access.

*Pack Sizes: 10×10 Blisters (Optimized specifically for strict 2-to-4 week acute psychiatric dispensing regimens to prevent dependency).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Psychiatric Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Controlled Substance Containment & Auditing: Manufacturing a highly potent, addictive benzodiazepine requires absolute regulatory perfection. Our facilities utilize strictly secured, camera-monitored manufacturing suites. Every single milligram of the Nitrazepam API is rigorously weighed, tracked, and reconciled by independent quality assurance officers. This absolute guarantee against product diversion allows us to seamlessly pass the most stringent international narcotic control audits.

Therapeutic Indications (Human Use)

Indicated for the short-term, targeted management of severe neurological and psychiatric dysfunction:

• Severe Insomnia: Short-term (2 to 4 weeks) treatment of insomnia when it is severe, disabling, or subjecting the individual to extreme distress.
• Myoclonic Seizures (Adjunct): Management of specific seizure profiles, including infantile spasms, in pediatric neurology (under strict specialist supervision).

Dosage & Administration

Recommended Dosage (Strictly as per Psychiatrist Guidelines):

• Adults: 5 mg to 10 mg taken orally just before retiring to bed.
• Elderly or Debilitated Patients: Strictly 2.5 mg to 5 mg to prevent severe respiratory depression and ataxia.
• Administration (THE FULL NIGHT RULE): The patient must ensure they have a full 7 to 8 hours dedicated to sleep after taking the tablet. Waking up earlier will result in severe anterograde amnesia and motor impairment.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Concomitant Use with Opioids): Combining Nitrazepam with opioid painkillers (e.g., Morphine, Tramadol) causes profound sedation, severe respiratory depression, coma, and death. This combination must be entirely avoided unless absolutely clinically necessary.
• Dependence, Tolerance, and Withdrawal: As a benzodiazepine, continuous use for more than 4 weeks leads to severe physical and psychological dependence. Abrupt cessation will cause violent withdrawal symptoms, including rebound insomnia, extreme anxiety, tremors, and potentially fatal withdrawal seizures. It must be tapered slowly.
• Next-Day “Hangover” Effect & Ataxia: Due to its long half-life, patients frequently experience heavy sedation, confusion, and muscle weakness the following day. This dramatically increases the risk of fatal car accidents and, in the elderly, catastrophic hip fractures from falls.
• Paradoxical Reactions: In rare cases (particularly in children and the elderly), instead of causing sleep, the drug triggers extreme aggression, hallucinations, and manic hyper-excitability.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Psychiatric Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced CNS and Controlled Psychotropic Formulations. Whether you are looking for a reliable Government Tender Supplier for mental health clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics and regulatory compliance teams ensure the timely, fully licensed, and secure delivery of WHO-GMP certified products.