Dosing & Uses
Dosage Forms & Strengths
intranasal spray: Schedule IV
- 5mg/0.1mL
- 7.5mg/0.1mL
- 10mg/0.1mL
Epilepsy
Indicated for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy
Adolescent or adult dose (0.2 mg/kg)
- 14-27 kg: 5 mg (one 5-mg device); 1 spray in 1 nostril
- 28-50 kg: 10 mg (one 10-mg device); 1 spray in 1 nostril
- 51-75 kg: 15 mg (two 7.5-mg devices); 1 spray in each nostril
- ≥76 kg: 20 mg (two 10-mg devices); 1 spray in each nostril
Second dose and maximum dose
- Second dose: When required, may be administered after at least 4 hr after initial dose; if the second dose is to be administered, use a new blister pack of diazepam intranasal
- Maximum dosage: Not to exceed 2 doses to treat a single episode
- Treatment frequency: Do not use for more than 1 episode q5days and no more than 5 episodes/month
Dosage Modifications
Renal impairment
- Not studied
Hepatic impairment
- Not studied
- Prescribing information describes literature review showing diazepam 0.1-0.15 mg/kg IV had prolonged half-life by 2- to 5-fold in patients with alcoholic cirrhosis
Dosage Forms & Strengths
intranasal spray: Schedule IV
- 5mg/0.1mL
- 7.5mg/0.1mL
- 10mg/0.1mL
Epilepsy
Indicated for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy aged ≥6 years
<6 years: Safety and efficacy not established
6-11 years (0.3 mg/kg)
- 10-18 kg: 5 mg (one 5-mg device); 1 spray in 1 nostril
- 19-37 kg: 10 mg (one 10-mg device); 1 spray in 1 nostril
- 38-55 kg: 15 mg (two 7.5-mg devices); 1 spray in each nostril
- 56-74 kg: 20 mg (two 10-mg devices); 1 spray in each nostril
12 years or older (0.2 mg/kg)
- 14-27 kg: 5 mg (one 5-mg device); 1 spray in 1 nostril
- 28-50 kg: 10 mg (one 10-mg device); 1 spray in 1 nostril
- 51-75 kg: 15 mg (two 7.5-mg devices); 1 spray in each nostril
- ≥76 kg: 20 mg (two 10-mg devices); 1 spray in each nostril
Second dose and maximum dose
- Second dose: When required, may be administered after at least 4 hr after initial dose; if the second dose is to be administered, use a new blister pack of diazepam intranasal
- Maximum dosage: Not to exceed 2 doses to treat a single episode
- Treatment frequency: Do not use for more than 1 episode q5days and no more than 5 episodes/month
Dosage Modifications
Renal impairment
- Not studied
Hepatic impairment
- Not studied
- Prescribing information describes literature review showing diazepam 0.1-0.15 mg/kg IV had prolonged half-life by 2- to 5-fold in patients with alcoholic cirrhosis
Dosing Considerations
Not approved for use in neonates or infants
Prolonged CNS depression observed with neonates treated with diazepam
Serious adverse reactions including fatal reactions and gasping syndrome occurred in premature neonates and low-birth-weight infants who received drugs containing benzyl alcohol as a preservative (diazepam intranasal contains benzyl alcohol 10.5 mg/0.1mL)
Epilepsy
Indicated for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy
Clinical studies did not include sufficient numbers of individuals aged ≥65 yr to determine whether they respond differently from younger patients
Caution in geriatric patients owing to increased half-life that corresponds to decreased clearance of free diazepam
Decreased dose recommended in older patients to reduce likelihood of ataxia or over sedation
Use with caution in patients with compromised respiratory function related to a concurrent disease process (eg, asthma, pneumonia) or neurologic damage
Adult dose (0.2 mg/kg)
- 14-27 kg: 5 mg (one 5-mg device); 1 spray in 1 nostril
- 28-50 kg: 10 mg (one 10-mg device); 1 spray in 1 nostril
- 51-75 kg: 15 mg (two 7.5-mg devices); 1 spray in each nostril
- ≥76 kg: 20 mg (two 10-mg devices); 1 spray in each nostril
Second dose and maximum dose
- Second dose: When required, may be administered after at least 4 hr after initial dose; if the second dose is to be administered, use a new blister pack of diazepam intranasal
- Maximum dosage: Not to exceed 2 doses to treat a single episode
- Treatment frequency: Do not use for more than 1 episode q5days and no more than 5 episodes/month
Dosage Modifications
Renal impairment
- Not studied
Hepatic impairment
- Not studied
- Prescribing information describes literature review showing diazepam 0.1-0.15 mg/kg IV had prolonged half-life by 2- to 5-fold in patients with alcoholic cirrhosis
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
Adverse effects reported in prescribing information based on data from diazepam rectal gel unless otherwise specified
>10%
Somnolence (23%)
1-10%
Headache (5%)
Diarrhea (4%)
Ataxia (3%)
Dizziness (3%)
Euphoria (3%)
Incoordination (3%)
Rash (3%)
Asthma (2%)
Vasodilation (2%)
Asthenia (≥1%)
Hypotension, vasodilatation (≥1%)
Agitation, confusion, convulsion, dysarthria, emotional lability, speech disorder, thinking abnormal, vertigo (≥1%)
Hiccup (≥1%)
Diazepam intranasal
- Nasal discomfort (6%)
- Nasal congestion (3%)
- Epistaxis (3%)
- Dysgeusia (2%)
Frequency Not Defined
The following infrequent adverse events have been reported previously with diazepam use: Depression, slurred speech, syncope, changes in libido, urinary retention, bradycardia, cardiovascular collapse, nystagmus, urticaria, neutropenia, and jaundice
Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances, and stimulation have been reported with other diazepam products
Warnings
Black Box Warnings
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate
Limit dosages and durations to minimum requirement
Monitor for signs and symptoms of respiratory depression and sedation
Contraindications
Hypersensitivity
Acute narrow angle glaucoma
Cautions
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death; because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate
May produce CNS depression; caution patients against engaging in hazardous activities requiring mental alertness until effects of the drug, such as drowsiness, have subsided, and as their medical condition permits
Caution in patients with compromised respiratory function related to a concurrent disease process (eg, asthma, pneumonia) or neurologic damage
Antiepileptic drugs (AEDs) increase risk of suicidal thoughts or behavior in patients taking these drugs for any indication; monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
Benzodiazepines can increase intraocular pressure in patients with glaucoma; may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy; diazepam is contraindicated in patients with narrow-angle glaucoma
Not approved for use in neonates or infants; diazepam intranasal contains benzyl alcohol, which can cause serious and fatal adverse reactions, including gasping syndrome, in neonates and low-birth-weight infants
Drug interaction overview
- Diazepam is a CYP2C19 and CYP3A4 substrate
- Coadministration of benzodiazepines and opioids increases risk of respiratory depression; limit dosage and duration if concomitantly used; monitor closely for respiratory depression and sedation
- Coadministration of other CNS depressants or alcohol consumption may potentiate CNS-depressant effects of diazepam
- CYP2C19 or CYP3A4 inhibitors: May decrease rate of diazepam elimination, thereby increasing adverse reactions to diazepam
- CYP2C19 or CYP3A4 inducers: May increase rate of diazepam elimination; therefore, efficacy of diazepam may be decreased
Pregnancy & Lactation
Pregnancy
North American Antiepileptic Drug (NAAED) Pregnancy Registry: 1-888-233-2334; http://www.aedpregnancyregistry.org
There are no adequate data on the use of diazepam intranasal in pregnant women
Available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies
Although some early epidemiological studies suggested a relationship between benzodiazepine use in pregnancy and congenital anomalies such as cleft lip and or palate, these studies had considerable limitations
More recently completed studies of benzodiazepine use in pregnancy have not consistently documented elevated risks for specific congenital anomalies
There is insufficient evidence to assess the effect of benzodiazepine pregnancy exposure on neurodevelopment
Neonatal withdrawal and floppy infant syndrome
- Neonatal withdrawal syndrome and symptoms suggestive of floppy infant syndrome associated with administration of benzodiazepines during the later stages of pregnancy and peripartum period have been reported
Animal data
- Increased incidences of fetal malformations in mice and hamsters when given PO at single doses of ≥100 mg/kg or greater (∼13 times the maximum recommended human dose [MRHD = 0.6mg/kg/day] or greater on a mg/m2 basis)
- Cleft palate and exencephaly are the most common and consistently reported malformations produced in these species by administration of high, maternally toxic doses of diazepam during organogenesis
Lactation
Diazepam is excreted in human milk
There are no data specifically for diazepam intranasal
Postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines may have effects of lethargy, somnolence, and poor sucking
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
The exact mechanism of action for diazepam is not fully understood, but it is thought to involve potentiation of gamma aminobutyric acid (GABA) neurotransmission resulting from binding at the benzodiazepine site of the GABA-A receptor
Absorption
Peak plasma concentration: 1.5 hr
Absolute bioavailability: 97%
Distribution
Protein bound: 95-98% (including active desmethyldiazepam metabolite)
Vd: 0.8-1 L/kg
Metabolism
Metabolism of diazepam is primarily hepatic and involves demethylation (primarily by CYP2C19 and CYP3A4) and 3-hydroxylation (primarily by CYP3A4), followed by glucuronidation
Elimination
Half-life: 49.2 hr (10-mg intranasal dose)
Administration
Intranasal Administration
For intranasal use only
No device assembly required; ready-to-use nasal spray device; do not open individual blister packs or test nasal spray devices before use
Do not use if nasal spray unit appears damaged
Each single-dose nasal spray device sprays 1 time and cannot be reused
Nasal spray delivers its entire contents upon activation
Before use, instruct individual administering diazepam intranasal on how to identify seizure clusters and how to appropriately administer the product
Storage
Store at 20-25ºC (68-77ºF); excursions permitted from 15-30ºC (59-86ºF)
Do not freeze
Protect from light
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Patient Handout
Formulary
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