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Nitrazepam (United States: Not available): Drug information

Nitrazepam (United States: Not available): Drug information
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For additional information see "Nitrazepam (United States: Not available): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: Canada
  • Mogadon
Pharmacologic Category
  • Benzodiazepine
Dosing: Adult

Dosage guidance:

Safety: Reduce dose or avoid use in patients receiving opioids. Avoid use in patients with a history of substance use, misuse of medications, or depression (Ref).

Insomnia, sleep onset or sleep maintenance

Insomnia, sleep onset or sleep maintenance (alternative agent):

Note: Due to risk of next day impairment, dependence, and habituation, benzodiazepines should be reserved for patients in whom alternative, safer therapies for insomnia have failed (Ref). When used, limit long-term use (>4 weeks) to cases for which nonpharmacologic treatments are not available or not effective and benefits are felt to outweigh risks (Ref).

Oral: Initial: 5 to 10 mg once daily at bedtime, as needed.

Discontinuation of therapy: Reduce by 25% of the original dose every 1 to 2 weeks until lowest available dose is reached, then discontinue. Patients on long-term therapy or in whom discontinuation has previously failed may benefit from a slower taper in conjunction with cognitive behavioral therapy for insomnia (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Liver Impairment: Adult

Mild-to-moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Severe impairment: Use is contraindicated.

Dosing: Older Adult

Insomnia: Elderly or debilitated patients: Note: Avoid use (Ref). Oral: Initial: 2.5 mg once daily, as needed, at bedtime; may increase dose to 5 mg at bedtime if tolerated (maximum dose: 5 mg/day).

Dosing: Pediatric
Myoclonic seizures

Myoclonic seizures: Infants and Children ≤30 kg: Oral: Usual dosage: 0.3 to 1 mg/kg/day in 3 equally divided doses; if doses are not divided equally, administer larger dose at bedtime. Note: Therapy should be initiated below the usual dosage range and titrated carefully based on response. If inadequate response to usual dosage, may gradually increase dose further. Manufacturer labeling does not specify a maximum dosage.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Liver Impairment: Pediatric

Mild-to-moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Severe impairment: Use is contraindicated.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Hypotension, palpitations

Dermatologic: Dermatological reaction

Endocrine & metabolic: Change in libido

Gastrointestinal: Constipation, diarrhea, dyspepsia, heartburn, nausea, sialorrhea (Jan 1971), vomiting

Hematologic & oncologic: Granulocytopenia, leukopenia

Hepatic: Abnormal hepatic function tests

Hypersensitivity: Anaphylaxis, angioedema

Nervous system: Abnormal dreams (depressed dreaming), abnormality in thinking, aggressive behavior, amnesia (including anterograde amnesia), apprehension, asthenia, ataxia (Jan 1971), behavioral changes (including disinhibition, inappropriate behavior), complex sleep-related disorder (including sleep driving), confusion, depersonalization, depression, disorientation, dizziness, drowsiness (Jan 1971), drug abuse, drug dependence (Clift 1972), emotional lability, falling, fatigue, hallucination, hangover effect (Charles 1987), headache, hypothermia (Impallomeni 1976), lethargy, nervousness, nightmares (Girwood 1973), paresthesia (MacLean 1973), sedated state, staggering, suicidal ideation, suicidal tendencies, withdrawal syndrome (including catatonia, delirium, muscle rigidity, rebound anxiety, rebound insomnia, tremor) (Adam 1976; Mackinnon 1982)

Ophthalmic: Blurred vision

Respiratory: Dyspnea, increased bronchial secretions (Jan 1971)

Miscellaneous: Paradoxical reaction (Nassr 1986)

Contraindications

Hypersensitivity to nitrazepam, benzodiazepines, or any component of the formulation; myasthenia gravis; severe respiratory insufficiency (eg, significant sleep apnea syndrome); severe hepatic insufficiency; use as hypnotic in children

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/anaphylactoid reactions: Have been reported with use (rare); patients who develop angioedema should not be rechallenged with nitrazepam.

• Anterograde amnesia: Benzodiazepines have been associated with anterograde amnesia (Nelson 1999). May also rarely induce transient global amnesia or traveler's amnesia (if taken to induce sleep while traveling); caution patients to ensure they have uninterrupted sleep of 7 to 8 hours after ingestion of dose.

• Aspiration pneumonia: Bronchial hypersecretion and excessive salivation/drooling leading to aspiration pneumonia in young and elderly patients may occur rarely.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Paradoxical reactions: Paradoxical reactions, including hyperactive or aggressive behavior, have been reported with benzodiazepines; risk may be increased in adolescent/pediatric patients, geriatric patients, or patients with a history of alcohol use disorder or psychiatric/personality disorders (Mancuso 2004).

• Rebound insomnia: Following withdrawal of therapy, transient insomnia may recur accompanied by other reactions including restlessness, anxiety, and mood changes.

• Sleep-related activities: Hazardous sleep-related activities such as sleep-driving, cooking and eating food, and making phone calls while asleep have been noted with benzodiazepines (Dolder 2008).

Disease-related concerns:

• Depression: Avoid use in patients with depression because of concerns about worsening mood symptoms, particularly if suicidal risk may be present, except for acute or emergency situations (eg, acute agitation, status epilepticus) (Craske 2022).

• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use.

• Hepatic impairment: Use with caution in patients with hepatic impairment (contraindicated in severe hepatic impairment).

• Renal impairment: Use with caution in patients with renal impairment.

• Respiratory disease: Reduce dose or avoid use in patients with respiratory disease, including chronic obstructive pulmonary disease or sleep apnea. Benzodiazepines may cause significant respiratory depression. Use is contraindicated in severe respiratory insufficiency.

• Sleep apnea: Benzodiazepines can suppress respiratory drive in patients with obstructive sleep apnea; use caution when prescribing for insomnia in this population (Webster 2020). Nitrazepam is contraindicated in cases of clinically significant sleep apnea.

Special populations:

• Debilitated patients: Use with caution in debilitated patients

• Older adult: Use with caution in older adults. Older adult patients may be at an increased risk of death with use; risk has been found highest within the first 4 months of use in older adult dementia patients (Jennum 2015; Saarelainen 2018).

• Fall risk: Use with extreme caution in patients who are at risk of falls; benzodiazepines have been associated with falls and traumatic injury (Nelson 1999).

• Pediatric: Associated with sudden death in children <5 years of age being treated for seizure disorders (Murphy 1987; Rintahaka 1999). Use should be restricted to children unresponsive to other antiseizure agents. Higher doses may cause excessive drowsiness and bronchial hypersecretion in infants and young children; evaluate infants prior to initiation of therapy to determine if upper airway is clear.

Other warnings/precautions:

• Appropriate use: Does not have analgesic, antidepressant, or antipsychotic properties.

• Hypnotic: Appropriate use: Should be used only after evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve after 7 to 10 days may indicate psychiatric and/or medical illness. A worsening of insomnia or the emergence of new abnormalities of thought or behavior may represent unrecognized psychiatric or medical illness and requires immediate and careful evaluation. Reassess patient for appropriateness of continued use after 2 to 3 weeks of consecutive treatment.

• Rebound insomnia: Following withdrawal of therapy, transient insomnia may recur accompanied by other reactions, including restlessness, anxiety, and mood changes.

• Tolerance: Nitrazepam is a long half-life benzodiazepine; duration of action after a single dose is determined by redistribution rather than metabolism (Brunton 2011). Tolerance develops to the hypnotic and antiseizure effects (Vinkers 2012). Chronic use of this agent may increase the perioperative benzodiazepine dose needed to achieve desired effect.

• Withdrawal: A longer sleep-onset latency and increased awakenings during sleep may occur for 1 to 2 days following the discontinuation of GABA-mediated (GABAergic) medications. A more severe withdrawal syndrome may rarely occur following abrupt discontinuation or large decreases in dose after sustained use (>10 days), and is characterized by new-onset agitation, ataxia, depersonalization, dizziness, dysphoria, fatigue, headache, hypersensitivity to stimuli, irritability, muscle cramps or pain, nausea, sweating, twitching, vomiting, and weakness. This withdrawal syndrome generally resolves within weeks or upon reinitiation of the GABAergic medication. Intermittent dosing may reduce the risk of withdrawal symptoms (BAP [Wilson 2019]). Use caution when reducing dose or withdrawing therapy; avoid abrupt discontinuation; decrease slowly and monitor for withdrawal symptoms.

Product Availability

Not available in the US

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Mogadon: 5 mg, 10 mg

Controlled Substance

CDSA IV

Administration: Adult

Oral: Tablets may be swallowed whole, crushed, or dissolved in liquid. For insomnia, administer at bedtime. For myoclonic seizures, administer in 3 equally divided doses, or if doses are not divided equally, give larger dose at bedtime.

Administration: Pediatric

Oral: Myoclonic seizures: Tablets may be swallowed whole, crushed, or dissolved in liquid. Administer in 3 equally divided doses, or if doses are not divided equally, give larger dose at bedtime.

Use: Labeled Indications

Note: Not approved in the United States.

Insomnia, sleep onset or sleep maintenance: Short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

Limitations of use: Restrict use to insomnia that impairs normal daytime functioning. Treatment should typically not exceed 7 to 10 consecutive days. Reevaluation of the patient is required if treatment continues for >2 to 3 consecutive weeks. Prescriptions should be written for short-term use (7 to 10 days) and limited to ≤1 month supply.

Seizures: Management of myoclonic seizures in children.

Medication Safety Issues
Older Adult: High-Risk Medication:

Beers Criteria: Benzodiazepines (nitrazepam) are identified in the Beers Criteria as potentially inappropriate medications to be avoided in patients 65 years and older due to risk of abuse, misuse, physical dependence and addiction. In addition, older adults have increased risk of impaired cognition, delirium, falls, fractures, and motor vehicle accidents with benzodiazepine use (Beers Criteria [AGS 2023]).

Metabolism/Transport Effects

Substrate of CYP3A4 (Major with inducers), CYP3A4 (Minor with inhibitors); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Acrivastine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Alcohol (Ethyl): CNS Depressants may increase CNS depressant effects of Alcohol (Ethyl). Risk C: Monitor

Alizapride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Amisulpride (Oral): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

ARIPiprazole Lauroxil: May increase CNS depressant effects of Benzodiazepines. ARIPiprazole Lauroxil may increase hypotensive effects of Benzodiazepines. Specifically, the risk of orthostatic hypotension may be increased. Risk C: Monitor

ARIPiprazole: May increase CNS depressant effects of Benzodiazepines. ARIPiprazole may increase hypotensive effects of Benzodiazepines. Specifically, orthostatic hypotension may be increased. Risk C: Monitor

Articaine: May increase CNS depressant effects of CNS Depressants. Management: Consider reducing the dose of articaine if possible when used in patients who are also receiving CNS depressants. Monitor for excessive CNS depressant effects with any combined use. Risk D: Consider Therapy Modification

Azelastine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Benperidol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Beta-Acetyldigoxin: Benzodiazepines may increase serum concentration of Beta-Acetyldigoxin. Risk C: Monitor

Blonanserin: CNS Depressants may increase CNS depressant effects of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider Therapy Modification

Brexanolone: CNS Depressants may increase CNS depressant effects of Brexanolone. Risk C: Monitor

Brimonidine (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromopride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromperidol: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Buclizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Buprenorphine: CNS Depressants may increase CNS depressant effects of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider Therapy Modification

BusPIRone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Cannabinoid-Containing Products: CNS Depressants may increase CNS depressant effects of Cannabinoid-Containing Products. Risk C: Monitor

Certoparin: May increase serum concentration of Benzodiazepines. Risk C: Monitor

Cetirizine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk D: Consider Therapy Modification

Chloral Hydrate/Chloral Betaine: CNS Depressants may increase CNS depressant effects of Chloral Hydrate/Chloral Betaine. Management: Consider alternatives to the use of chloral hydrate or chloral betaine and additional CNS depressants. If combined, consider a dose reduction of either agent and monitor closely for enhanced CNS depressive effects. Risk D: Consider Therapy Modification

Chlormethiazole: May increase CNS depressant effects of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider Therapy Modification

Chlorphenesin Carbamate: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

CloZAPine: Benzodiazepines may increase adverse/toxic effects of CloZAPine. Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine. Monitor for respiratory depression, hypotension, and other toxicities if these agents are combined. Risk D: Consider Therapy Modification

CNS Depressants: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Corticosteroids (Orally Inhaled): Benzodiazepines may increase adverse/toxic effects of Corticosteroids (Orally Inhaled). Specifically, the risk of pneumonia may be increased. Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of Nitrazepam. Risk C: Monitor

Dantrolene: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Daridorexant: May increase CNS depressant effects of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

DexmedeTOMIDine: CNS Depressants may increase CNS depressant effects of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider Therapy Modification

Difelikefalin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Difenoxin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dihydralazine: CNS Depressants may increase hypotensive effects of Dihydralazine. Risk C: Monitor

Dimethindene (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dothiepin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Doxylamine: CNS Depressants may increase CNS depressant effects of Doxylamine. Risk C: Monitor

DroPERidol: May increase CNS depressant effects of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider Therapy Modification

Emedastine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk C: Monitor

Entacapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Esketamine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Flunarizine: CNS Depressants may increase CNS depressant effects of Flunarizine. Risk X: Avoid

Flunitrazepam: CNS Depressants may increase CNS depressant effects of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider Therapy Modification

HydrOXYzine: May increase CNS depressant effects of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider Therapy Modification

Ilaprazole: May increase serum concentration of Benzodiazepines. Risk C: Monitor

Ixabepilone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kava Kava: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ketotifen (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kratom: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Lemborexant: May increase CNS depressant effects of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider Therapy Modification

Levocetirizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lisuride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofepramine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofexidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Loxapine: CNS Depressants may increase CNS depressant effects of Loxapine. Management: Consider reducing the dose of CNS depressants administered concomitantly with loxapine due to an increased risk of respiratory depression, sedation, hypotension, and syncope. Risk D: Consider Therapy Modification

Magnesium Sulfate: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Melatonin: May increase sedative effects of Benzodiazepines. Risk C: Monitor

Melitracen [INT]: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Mequitazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metergoline: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Methadone: Benzodiazepines may increase CNS depressant effects of Methadone. Management: Clinicians should generally avoid concurrent use of methadone and benzodiazepines when possible; any combined use should be undertaken with extra caution. Risk D: Consider Therapy Modification

Methotrimeprazine: CNS Depressants may increase CNS depressant effects of Methotrimeprazine. Methotrimeprazine may increase CNS depressant effects of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider Therapy Modification

Methoxyflurane: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metoclopramide: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

MetyroSINE: CNS Depressants may increase sedative effects of MetyroSINE. Risk C: Monitor

Minocycline (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Moxonidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Nabilone: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Nalfurafine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Noscapine: CNS Depressants may increase adverse/toxic effects of Noscapine. Risk X: Avoid

OLANZapine: Benzodiazepines may increase adverse/toxic effects of OLANZapine. Management: Monitor closely for hypotension, respiratory or central nervous system depression, and bradycardia if olanzapine is combined with benzodiazepines. Use of parenteral benzodiazepines with IM olanzapine is not recommended. Risk C: Monitor

Olopatadine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Opicapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Opioid Agonists: CNS Depressants may increase CNS depressant effects of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Opipramol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Orphenadrine: CNS Depressants may increase CNS depressant effects of Orphenadrine. Risk X: Avoid

Oxomemazine: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Oxybate Salt Products: Benzodiazepines may increase CNS depressant effects of Oxybate Salt Products. Risk X: Avoid

OxyCODONE: CNS Depressants may increase CNS depressant effects of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Paliperidone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Paraldehyde: CNS Depressants may increase CNS depressant effects of Paraldehyde. Risk X: Avoid

Perampanel: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Periciazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pipamperone: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Piribedil: CNS Depressants may increase CNS depressant effects of Piribedil. Risk C: Monitor

Pizotifen: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pramipexole: CNS Depressants may increase sedative effects of Pramipexole. Risk C: Monitor

Procarbazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Rilmenidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ropeginterferon Alfa-2b: CNS Depressants may increase adverse/toxic effects of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider Therapy Modification

ROPINIRole: CNS Depressants may increase sedative effects of ROPINIRole. Risk C: Monitor

Rotigotine: CNS Depressants may increase sedative effects of Rotigotine. Risk C: Monitor

Suvorexant: CNS Depressants may increase CNS depressant effects of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

Teduglutide: May increase serum concentration of Benzodiazepines. Risk C: Monitor

Thalidomide: CNS Depressants may increase CNS depressant effects of Thalidomide. Risk X: Avoid

Theophylline Derivatives: May decrease therapeutic effects of Benzodiazepines. Risk C: Monitor

Trimeprazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Valerian: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Yohimbine: May decrease therapeutic effects of Antianxiety Agents. Risk C: Monitor

Zolpidem: CNS Depressants may increase CNS depressant effects of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider Therapy Modification

Zuranolone: May increase CNS depressant effects of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider Therapy Modification

Reproductive Considerations

Manage epilepsy in patients who could become pregnant based on a shared decision-making process that optimizes seizure control and considers the possibility of pregnancy during treatment (Pack 2024). Regularly discuss age-specific and developmental needs, including pregnancy planning and contraceptive options during the patient's reproductive lifespan (ACOG 2020; NICE 2022).

Pregnancy Considerations

Nitrazepam crosses the placenta (Kangas 1977).

In-utero exposure to benzodiazepines has the potential to cause harm to the fetus. Teratogenic effects have been observed in some studies; however, a clear association has not been reported and additional data are needed (Bellantuono 2013; Chuang 2024; Freeman 2018; Grigoriadis 2019; Tinker 2019; Wu 2024). Data are insufficient to evaluate the risk of specific major congenital malformations following in utero exposure to nitrazepam (Pack 2024). Exposure to a benzodiazepine late in pregnancy may cause neonatal sedation (hypotonia, lethargy, respiratory depression) and/or symptoms of neonatal withdrawal (feeding difficulties, hyperreflexia, inconsolable crying, irritability, restlessness, tremors) (Iqbal 2002). Monitor newborns exposed to nitrazepam in utero for adverse events. Data related to long-term effects on neurodevelopment following maternal use of benzodiazepines are inconclusive (Andrade 2024; Radojčić 2017; Sundbakk 2025; Wang 2022) and data are insufficient to evaluate the risk of neurodevelopmental outcomes (IQ scores or autism spectrum disorder) in children following in utero exposure to nitrazepam (Pack 2024). Screen for major congenital malformations and monitor fetal growth when antiseizure medications are used during pregnancy. Conduct age-appropriate developmental screening in children with previous in utero exposure to antiseizure medications (Pack 2024).

Epilepsy is associated with adverse maternal and fetal outcomes (Kuang 2024; Mazzone 2023). Convulsive seizures should be minimized to reduce risks to the fetus and pregnant patient. Use caution if removing or replacing an effective seizure medication in patients who become pregnant during therapy. Folic acid supplementation prior to and during pregnancy minimizes the risk of congenital malformations and poor neurodevelopment (Pack 2024).

Treatment for insomnia in pregnant patients should be individualized. Untreated insomnia may lead to adverse pregnancy outcomes. Although recommendations vary, nonpharmacologic therapy is preferred as an initial treatment of insomnia during pregnancy (BAP [McAllister-Williams 2017]; BAP [Wilson 2019]; Palagini 2022).

Breastfeeding Considerations

Nitrazepam is present in breast milk (Kangas 1981; Matheson 1990).

Drowsiness, lethargy, or weight loss in nursing infants have been observed in case reports following maternal use of some benzodiazepines, including nitrazepam (Iqbal 2002; Speight 1977).

Breastfeeding is not recommended by the manufacturer. Infants exposed to nitrazepam via breast milk should be monitored for adverse events, including irritability and sedation. Consider the long half-life of nitrazepam and the potential for accumulation.

Monitoring Parameters

Respiratory, cardiovascular, and mental status

Reference Range

Steady state levels after 4 days: 40 ng/mL (SI: 142.4 nmol/L).

Mechanism of Action

Intermediate-acting benzodiazepine (based on half-life) (Griffin 2013). Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the CNS, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization. Benzodiazepine receptors and effects appear to be linked to the GABA-A receptors. Benzodiazepines do not bind to GABA-B receptors.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 20 to 50 minutes.

Absorption: Rapid.

Duration of action: Classified as an intermediate-acting benzodiazepine; classification based on benzodiazepines with half-life of 12 to 40 hours (Griffin 2013).

Distribution: Vd: 2.4 L/kg (range: 1.6 to 3.2 L/kg), Elderly: 4.8 L/kg (range: 3.1 to 6.5 L/kg); also distributes into CSF, saliva (Kangas 1979).

Protein binding: 87%.

Metabolism: Hepatic: Nitroreduction, acetylation; no active metabolites.

Bioavailability: ~80%.

Half-life elimination: 30 hours (range: 18 to 57 hours), Elderly/ill patients: 40 hours.

Time to peak, plasma: ~3 hours.

Excretion: Urine (65% to 71%, ~1% as unchanged drug); feces (14% to 20%).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Mogadon | Somnite;
  • (AT) Austria: Mogadon;
  • (AU) Australia: Alodorm | Mogadon;
  • (BD) Bangladesh: Amoctin | Epam | Eunoctin | Noctin | Relactin;
  • (BE) Belgium: Mogadon | Nitrazepam teva generics belgium;
  • (BG) Bulgaria: Berlidorm | Radedorm;
  • (BR) Brazil: Nitrapan | Nitrazepol | Sonebon;
  • (CH) Switzerland: Mogadon;
  • (DE) Germany: Dormalon | Dormalon nitrazepam | Imeson | Mogadon | Nitrazepam al | Novanox;
  • (DO) Dominican Republic: Hipnotab | Quill;
  • (EC) Ecuador: Somnil;
  • (EE) Estonia: Berlidorm | Dima-10 | Eatan n | Eunoctin | Nitrazepam accord | Nitrazepam-alpharma | Nomefren | Radedorm;
  • (ES) Spain: Nitrazepan;
  • (FI) Finland: Apodorm | Insomin | Mogadon | Nitrazepam accord | Pacisyn | Somitran;
  • (FR) France: Mogadon;
  • (GB) United Kingdom: Mogadon | Nitrados | Nitrazepam almus | Nitrazepam arrow | Nitrazepam berk | Nitrazepam dc | Nitrazepam kent | Nitreeze | Noctesed | Remnos | Somnased | Somnite | Unisomnia;
  • (HK) Hong Kong: Dima | Mogadon | Nipa;
  • (HR) Croatia: Cerson;
  • (HU) Hungary: Eunoctin;
  • (ID) Indonesia: Dumolid | Mogadon | Somnil;
  • (IE) Ireland: Mogadon | Somnite;
  • (IL) Israel: Numbon;
  • (IN) India: Baronite | Calmtra | Dormin | Halonite | Hypnoril | Manonit | Nicare | Nidra | Nigap | Nipam | Nira | Nitavan | Nitcalm | Nite | Nithra | Nitpro | Nitraplan | Nitravet | Nitrosun | Nitrosym | Niz | Stressban;
  • (IT) Italy: Mogadon;
  • (JP) Japan: Benzalin | Calsmin | Chiorazepam | Cysvon | Hirusukamin | Nelbon | Nelmat | Nelurolen | Nemnamine | Neuchlonic | Nitrazepam amel | Nitrazepam bmj | Nitrazepam nichiiko | Nitrazepam okura | Nitrazepam teva | Nitrazepam towa | Nitrazepam zensei;
  • (KR) Korea, Republic of: Mogadon;
  • (LB) Lebanon: Mogadon;
  • (LT) Lithuania: Berlidorm | Eunoctin | Imeson | Nitrazepam bp | Radedorm;
  • (LU) Luxembourg: Mogadon;
  • (LV) Latvia: Berlidorm | Eunoctin | Imeson | Nitrazepam accord | Radedorm | Sleep;
  • (MY) Malaysia: Mogadon | Nitramin | Nitrapam;
  • (NL) Netherlands: Mogadon | Nitrazepam A | Nitrazepam Actavis;
  • (NO) Norway: Apodorm | Mogadon | Nitrazepam accord;
  • (NZ) New Zealand: Insoma | Nitrados;
  • (PK) Pakistan: Mogadon | Nitpam;
  • (PL) Poland: Nomefren | Radedorm;
  • (QA) Qatar: Mogadon;
  • (RU) Russian Federation: Berlidorm | Eunoctin | Nitrosan | Nozepam | Radedorm;
  • (SA) Saudi Arabia: Mogadon;
  • (SE) Sweden: Apodorm | Dumolid | Mogadon | Nitrazepam recip;
  • (SG) Singapore: Dima | Nitrados;
  • (SI) Slovenia: Cerson;
  • (TH) Thailand: Alodorm | Eunoctin | Mogadon | Nitrados;
  • (TN) Tunisia: Mogadon;
  • (TR) Turkey: Mogadon;
  • (TW) Taiwan: An-sleeper | Answet | Hirusukamin | Limin | Mogadon | Mudamin | Nitraze | Nitromin | Osmin | Sleep | Sleepin | Slomin | Susui;
  • (UA) Ukraine: Berlidorm | Eunoctin | Nitrosun | Radedorm;
  • (UY) Uruguay: Mogadon;
  • (VE) Venezuela, Bolivarian Republic of: Mogadon | Onirema;
  • (ZA) South Africa: Arem | Mogadon
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