EpilepsyRx

Nitrazepam

Nitrazepam Auro (Netherlands)

Seizure aggravation / coverage
Abrupt withdrawal can provoke seizures. The Dutch label discusses companion anticonvulsants to prevent convulsive seizures; this historical wording is not a general combination recommendation.

Antiseizure indications · Netherlands product label

Indication / use

Label / evidence summary
No US antiseizure indication. Netherlands: Nitrazepam Auro is labeled for infantile spasms with hypsarrhythmia (West syndrome, within infantile epileptic spasms syndrome) and typical / atypical absence seizures in the label’s historical Lennox syndrome category (Lennox-Gastaut syndrome).
Role
Maintenance · Netherlands label
Class
1,4-benzodiazepine

No US antiseizure indication. Netherlands national product labeling is summarized here; this is not an EU-wide authorization. Other countries and products may have different indications.

Formulations & strengths

Netherlands product label; strengths per dosage unit.

Brand & formulation labels

Each link names the product and formulation it covers. Archived labels do not establish current availability.

Dosing & administration

Adult / product-specific schedule
The Dutch label supplies pediatric epilepsy schedules; its adult bedtime schedule is for insomnia and is not presented here as an antiseizure regimen.
Pediatric
Dutch label: infants / children under 1 year, 5–10 mg/day; children 1–14 years, 15 mg/day, divided into three doses where possible. These are label schedules requiring specialist individualization, not starting-dose advice.
Titration / repeat dosing
Individualize, monitor accumulation and respiratory secretions, and taper rather than stop abruptly. The label’s historical combination-treatment language requires specialist interpretation.
Dose basis
Netherlands product label; not a US dosing recommendation.

Practical administration

Product instructions
Oral 5 mg tablets; the label permits whole, divided or water-dispersed administration.

Dose adjustment & concentrations

Renal impairment
Use cautiously; elimination is mainly by hepatic metabolism.
Hepatic impairment
Severe hepatic insufficiency is contraindicated; impaired liver function can prolong elimination.
Serum reference information
No therapeutic serum range is specified in the cited label.

Safety

Boxed warning
No US approved human label; consult the linked national label for serious precautions.
Contraindications
Myasthenia gravis; severe respiratory or hepatic insufficiency; sleep apnea; hypersensitivity to benzodiazepines or product ingredients.
Serious precautions & monitoring
Respiratory depression, dependence and withdrawal seizures. Excess bronchial secretions / salivation can cause aspiration, particularly in infants. Opioid co-use can cause coma or death.

Common / selected adverse effects

  • Sedation
  • Ataxia / muscle weakness
  • Amnesia
  • Paradoxical agitation
  • Excess respiratory secretions

Selected label-reported effects; frequencies cannot be compared across drugs.

Drug interactions: toxicity & clinical action

Partner / combinationClinical effectClinical action
Opioids / other CNS depressants / alcoholAdditive sedation and respiratory depression.Review combined exposure and monitor closely; avoid alcohol.
Hepatic enzyme inhibitorsMay increase benzodiazepine activity.Monitor accumulation and adverse effects.
FlumazenilMay reverse antiseizure activity and provoke seizures.Specialist emergency assessment is required.

Selected interactions; consult the full product label.

Pregnancy & contraception

Fetal / neonatal risk
Human pregnancy evidence is insufficient. Late exposure may cause neonatal hypotonia, respiratory depression or withdrawal; the Dutch label prohibits use while breastfeeding.

Clinical evidence

Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.

Extrapolation

Trial summary

Study design / duration
A 1986 randomized multicenter study evaluated 48 infants under 2 years over four weeks; a separate 1996 open-label series studied refractory infantile spasms and Lennox-Gastaut syndrome.
Primary endpoint
No single pivotal endpoint is identified in the cited source.
Results
The randomized study found reduced spasm frequency in both nitrazepam and corticotropin groups without a statistically significant between-group difference. This does not establish equivalence or a current first-line recommendation.

Trial publications

Comparative evidence

Findings
The linked studies concern selected pediatric populations; national labeling and study results do not establish US approval.

Mechanism of action

  • A 1,4-benzodiazepine that acts as a positive allosteric modulator at benzodiazepine-sensitive GABA-A receptors, enhancing GABA-mediated chloride-channel activity and neuronal inhibition.

Pharmacology

Adult values unless specified. Vd/F denotes apparent oral distribution volume.

Pharmacokinetics

Bioavailability
The Dutch SmPC describes complete gastrointestinal absorption; it does not provide a measured absolute-bioavailability percentage.
Elimination half-life
Mean 30 hours; approximately 40 hours in older adults.
Volume of distribution
Approximately 2 L/kg in younger subjects.
Active metabolite(s)
7-aminonitrazepam and 7-acetamidonitrazepam do not contribute to clinical activity according to the Dutch SmPC.
Active-metabolite half-life
Not applicable: no active metabolite identified.
Protein binding
85–90%.
Metabolism / elimination
Hepatic reduction and acetylation; little parent drug appears unchanged in urine.

Product-label values depend on population and study conditions.

Molecular structure

Molecular structure of Nitrazepam
PubChem structure of the named compound.
NIH PubChem structure and record ↗

Product history

Initial U.S. approval
No US antiseizure indication. Netherlands authorization: RVG 50283, first authorized 27 April 1992.
Market / formulation history
Netherlands national authorization; this does not establish EU-wide authorization or availability in other countries.
Brands
Nitrazepam Auro (Netherlands)
Manufacturer / marketer
Aurobindo Pharma B.V. (cited Dutch product)
Generic availability
Availability and product labeling are country-specific.
Related drugs
Not summarized.

Sources & review status

The Nitrazepam Auro SmPC is a representative Netherlands product source. Antiseizure indications must not be assumed for other brands or countries.

Netherlands label checked: 2026-09-27. Other profile sources reviewed: 2026-09-27 · label revision noted at that review: Nitrazepam Auro SmPC, partial revision 21 September 2023.. This is a draft reference; final review is pending.

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