Epam5 mg

Established / Approved Uses

• Short-term treatment of insomnia that is severe, disabling, or causing extreme distress, where sleep-onset or sleep-maintenance difficulty is significant. Epam is indicated only for short courses (see Duration of Treatment).

Guideline-Supported / Regionally Approved Uses

• Myoclonic seizures and infantile spasms (West syndrome) — in several countries Epam is approved as an anticonvulsant, used alone or as adjunct therapy, particularly in children who have not responded adequately to first-line agents.

Not Recommended / Off-Label

Epam is not indicated for long-term management of chronic insomnia, for anxiety as a first-line agent, or for routine daytime sedation. Use outside the above indications should only occur under specialist supervision.

Each tablet contains Nitrazepam INN 5 mg. Lower-strength tablets (e.g., 2.5 mg) may also be available for elderly or debilitated patients and for pediatric anticonvulsant dosing.

Epam is a long-acting benzodiazepine derivative with hypnotic and anticonvulsant properties. It is used for the short-term relief of severe insomnia and, in some countries, as an anticonvulsant for myoclonic seizures and infantile spasms. Like other benzodiazepines, Epam acts on the central nervous system to produce sedative, muscle-relaxant, and anti-anxiety effects, but carries risks of dependence, tolerance, and withdrawal with prolonged use.

Benzodiazepine — Hypnotic and Anticonvulsant

Mode of Action

Nitrazepam binds to a specific site on the GABA-A receptor complex in the central nervous system, enhancing the inhibitory effect of gamma-aminobutyric acid (GABA). This increases the frequency of chloride channel opening, causing neuronal hyperpolarization and reduced neuronal excitability, which produces sedative, hypnotic, anxiolytic, muscle-relaxant, and anticonvulsant effects.

Pharmacokinetics

• Absorption: Well absorbed after oral administration; peak plasma concentration reached in 1–3 hours.
• Metabolism: Extensively metabolized in the liver, mainly by reduction and acetylation, to largely inactive metabolites (unlike some benzodiazepines, it does not form long-acting active metabolites).
• Half-life: Approximately 15–38 hours, which contributes to next-day residual sedation.
• Excretion: Primarily via the kidneys as metabolites.

Epam tablets are taken orally, swallowed whole with water, generally just before bedtime when used for insomnia. It may be taken with or without food. Do not increase the dose or frequency on your own, and do not stop abruptly after prolonged use without medical guidance (see Precautions and Warnings).

• Opioids: Concomitant use of Epam with opioid analgesics or opioid-containing cough/cold products can cause profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for cases where alternative treatment options are inadequate, and use the lowest effective doses for the shortest duration.
• Other CNS depressants (alcohol, other sedative-hypnotics, other benzodiazepines, sedating antihistamines, general anesthetics): Additive CNS and respiratory depression; avoid or use with extreme caution.
• Strong CYP enzyme inhibitors/inducers: Drugs that significantly alter hepatic metabolism (e.g., certain antifungals, some anticonvulsants) may increase or decrease Epam plasma levels; monitor for altered sedative effect.
• Muscle relaxants: May enhance the muscle-relaxant effect of Epam, increasing fall risk, particularly in the elderly.

Common

• Drowsiness and next-day sedation
• Dizziness, light-headedness
• Ataxia and unsteady gait (especially in the elderly)
• Headache
• Muscle weakness

Less Common

• Paradoxical reactions: agitation, irritability, aggression, confusion (more frequent in children and the elderly)
• Dry mouth, gastrointestinal upset
• Visual disturbances

Serious (Rare but Important)

• Respiratory depression, particularly when combined with opioids, alcohol, or other CNS depressants (see Interactions)
• Physical and psychological dependence with prolonged use (see Precautions and Warnings)
• Severe allergic reaction (rash, angioedema)

Pregnancy: Epam should be avoided during pregnancy, particularly the first trimester, unless there is no safer alternative and the potential benefit clearly justifies the potential risk to the fetus; benzodiazepine use late in pregnancy has been associated with neonatal sedation and, with prolonged use, a neonatal withdrawal syndrome. Use only under close medical supervision if considered essential, and consult a physician before use.

Lactation: Epam passes into breast milk and may cause sedation, poor feeding, or weight loss in the breastfed infant. Breastfeeding is generally not recommended during treatment; a physician should be consulted to weigh the risks and benefits.

• Dependence and withdrawal: Prolonged use of Epam can lead to physical and psychological dependence and tolerance. Abrupt discontinuation after regular use may cause a withdrawal syndrome (anxiety, tremor, sweating, insomnia, seizures in severe cases); doses should be tapered gradually under medical supervision.
• Duration of use: Use for the shortest duration possible, typically no more than 2–4 weeks including a tapering period, for insomnia (see Duration of Treatment).
• Rebound insomnia: Sleep disturbance may transiently worsen for one or more nights after stopping Epam.
• Next-day impairment: Epam can impair alertness, coordination, and psychomotor function the day after a dose. Patients should not drive or operate hazardous machinery until they know how they are affected, and impairment may not be subjectively noticed.
• Paradoxical reactions: Agitation, aggression, and confusion can occur, especially in children and the elderly; discontinue if these occur.
• Elderly patients: Increased sensitivity to sedative effects and elevated risk of falls and fractures; use the lowest effective dose.
• Respiratory disease: Use with caution in patients with compromised respiratory function (short of the absolute contraindications listed above).
• History of substance use disorder: Use with particular caution and close monitoring due to higher risk of misuse and dependence.

Overdose with Epam, especially combined with alcohol or other CNS depressants, can cause excessive drowsiness, confusion, slurred speech, ataxia, hypotonia, hypotension, respiratory depression, and coma, and can be fatal. Seek immediate medical attention or contact emergency services / a poison control center if overdose is suspected. Management is supportive (airway protection, monitoring of respiration and cardiovascular status); the benzodiazepine antagonist flumazenil may be considered by medical professionals in a hospital setting but carries its own risks (e.g., precipitating seizures) and must only be administered by trained personnel. Do not attempt home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly

Use a lower starting dose (e.g., 2.5 mg for insomnia) due to increased sensitivity to sedation, ataxia, and fall risk.

Pediatric

Epam is not recommended for insomnia in children. For myoclonic seizures/infantile spasms in countries where this use is approved, dosing is weight-based and must be individualized and supervised by a pediatric neurologist; safety and efficacy for other pediatric uses have not been established.

Renal Impairment

Use with caution; no formal dose adjustment established, but reduced clearance may increase sedative effect.

Hepatic Impairment

Use a reduced dose with caution in mild-to-moderate impairment; contraindicated in severe hepatic impairment.

For insomnia, Epam should be used for the shortest period possible, typically 2–4 weeks in total, including any tapering, with periodic reassessment of continued need. For anticonvulsant use in infantile spasms/myoclonic seizures, duration is determined by the treating specialist based on seizure control and tolerability.

Benzodiazepines

Nitrazepam is a positive allosteric modulator at the GABA-A receptor, enhancing GABA-mediated chloride influx and neuronal inhibition, which produces its sedative-hypnotic and anticonvulsant effects.

Epam is not approved for insomnia in children. In select countries it is used, under specialist supervision, for myoclonic seizures and infantile spasms (West syndrome) with weight-based, individualized dosing. Safety and efficacy for other pediatric indications have not been established, and paradoxical reactions (agitation, aggression) are more common in children.