Approved indications
Valtoco is approved as a rescue medicine for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that differ from a person's usual seizures in patients with epilepsy 2 years of age and older.

Off-label uses
Clinicians may use Valtoco off label within epilepsy care, such as in specific epilepsy syndromes (for example Lennox–Gastaut syndrome or epileptic encephalopathies) and in people already taking chronic benzodiazepines, still for seizure clusters; evidence comes mainly from open-label safety and effectiveness studies rather than large randomized trials.

Efficacy expectations

• In clinical studies and long-term open-label use, most seizure clusters stop after a single Valtoco dose, and only a minority (roughly one in ten) require a second dose within 24 hours.
• Median time to seizure cessation is on the order of a few minutes after dosing, especially when the spray is given promptly at the start of a cluster, though individual responses vary.
• Seizure control is comparable to rectal diazepam, but Valtoco offers more consistent drug levels and easier, socially acceptable intranasal administration, which can support faster and more reliable real-world use.

Typical dosing ranges
Dosing is based on age and weight: children 2–5 years typically receive about 0.5 mg/kg, ages 6–11 years about 0.3 mg/kg, and ages 12 years and older about 0.2 mg/kg, using fixed nasal spray strengths of 5, 7.5, or 10 mg per spray to give a total dose of 5, 10, 15, or 20 mg.

For 5 mg and 10 mg doses, a single spray is given into one nostril; 15 mg and 20 mg doses use two devices, with one spray into each nostril.

How and when to take it
Valtoco is for intranasal use only and can be given with or without food; it should be used at the start of a seizure cluster as specified in the person's seizure action plan by a trained patient or caregiver.

Do not test or prime the spray; each device contains a single premeasured dose and should not be reused.

Special dosing instructions
If needed, a second dose may be given at least 4 hours after the first, using a new blister pack, and no more than 2 doses should be used to treat a single seizure cluster episode.

Label guidance recommends using Valtoco for no more than one seizure cluster episode every 5 days and not more than five seizure cluster episodes in 1 month; more frequent episodes should prompt urgent reassessment of the overall seizure treatment plan.

Missed-dose guidance and overdose
Because Valtoco is a rescue medicine used only when seizure clusters occur, there is no routine daily schedule; if a cluster has already ended, the dose should be skipped rather than made up.

If too much Valtoco is given or if the person shows signs of overdose (extreme sleepiness, confusion, slow or shallow breathing, or loss of consciousness), emergency medical services and/or poison control should be contacted immediately.

Common side effects
Common reactions include sleepiness or drowsiness, headache, and nasal discomfort or irritation; these usually begin soon after dosing, are mild to moderate, and resolve within hours.

Other non-serious effects can include dizziness, fatigue, changes in taste or smell, runny nose, or throat irritation.

Serious or rare adverse effects

• Severe sedation, confusion, or unresponsiveness.
• Slow or difficult breathing, bluish lips or skin, or loud or unusual breathing, especially when Valtoco is used with opioids, alcohol, or other sedating drugs.
• Allergic reactions such as rash, hives, swelling of the face or throat, or trouble breathing.
• Worsening depression, unusual behavior, agitation, or suicidal thoughts.
• Worsening glaucoma symptoms (eye pain, vision changes) in people with glaucoma.

Warnings and precautions
Valtoco carries boxed warnings for combined use with opioids, risk of abuse, misuse, and addiction, and risk of dependence and withdrawal if benzodiazepines are used more often or at higher doses than recommended.

Use with caution in people with severe lung disease or sleep apnea, liver impairment, myasthenia gravis, significant weakness, a history of substance use disorder, or mood or anxiety disorders, and in older adults who are more prone to falls and confusion.

In pregnancy, benzodiazepines may increase risks such as neonatal sedation or withdrawal, so Valtoco is generally reserved for situations where the expected benefit clearly outweighs potential risks.

Diazepam passes into breast milk; if used while breastfeeding, caregivers should watch the infant for excessive sleepiness, poor feeding, or poor weight gain and seek medical advice if these occur.

Safety compared with other rescue medicines
When used intermittently as directed, the overall safety profile of intranasal diazepam is similar to other benzodiazepine rescue therapies, with the same systemic risks but the added convenience of nasal dosing and avoidance of rectal administration.

Reporting side effects
Patients and caregivers should contact the prescriber about any side effects and can report them directly to the FDA MedWatch program (online or by calling 1-800-FDA-1088) for safety updates and further guidance.

Drug and substance interactions
Valtoco can increase sedation and breathing problems when combined with opioids, alcohol, other benzodiazepines, sleep medicines, certain antidepressants, antipsychotics, antihistamines, and other central nervous system depressants.

Medicines that affect liver enzymes that metabolize diazepam (such as some azole antifungals, macrolide antibiotics, certain antiepileptic drugs, and some HIV medicines) may raise or lower diazepam levels, potentially changing its effect; prescribers may adjust therapy or increase monitoring in these situations.

Avoid alcohol use around the time of dosing, and use caution with cannabis or other recreational sedatives.

Conditions and co-medications requiring caution
Use Valtoco carefully or avoid it in people with severe respiratory disease or sleep apnea, significant liver impairment, acute narrow-angle glaucoma (where it is contraindicated), myasthenia gravis or severe muscle weakness, or a history of benzodiazepine or other substance misuse.

Because benzodiazepines can worsen mood or increase suicidal thoughts in some people, extra caution and close follow-up are important in patients with depression or other psychiatric disorders.

Older adults and frail patients may be more sensitive to sedating and balance-impairing effects, increasing the risk of falls.

Monitoring needs
For most people, no routine blood tests or ECGs are required specifically for Valtoco, but caregivers should closely observe the person after dosing for level of alertness, breathing pattern, skin color, and seizure control and seek emergency help if there are concerning changes.

In patients with liver disease, very frequent benzodiazepine use, or complex medication regimens, clinicians may periodically review liver function and all medicines to minimize interactions and drug accumulation.

Q: What is Valtoco used for?
A: Valtoco is a nasal spray form of diazepam used as a rescue medicine to quickly treat seizure clusters (episodes of frequent seizures that are different from usual) in people with epilepsy 2 years of age and older.

Q: How fast does Valtoco start working?
A: In studies, many seizure clusters stopped within minutes after a dose, especially when Valtoco was given soon after the cluster started, but the exact time to improvement can vary from person to person and episode to episode.

Q: How often can Valtoco be used?
A: You can usually give one dose at the start of a seizure cluster and a second dose at least 4 hours later if needed, but it should not be used to treat more than one episode every 5 days or more than five episodes in a month.

Q: Can children use Valtoco?
A: Yes, Valtoco is approved for children 2 years and older with epilepsy who have seizure clusters, with the dose chosen by the prescriber based on the child's age and weight.

Q: Is Valtoco addictive?
A: Like all benzodiazepines, diazepam can cause dependence and withdrawal if used too often or at high doses, so Valtoco is intended only for occasional rescue use according to a seizure action plan from a healthcare provider.

Q: Can I drive after taking Valtoco?
A: Because Valtoco can cause drowsiness, slowed thinking, and impaired coordination, the treated person should not drive, operate machinery, or do activities that require full alertness until they have completely recovered and been advised it is safe to do so.

Storage
Store Valtoco at room temperature (68°F to 77°F / 20°C to 25°C), keep it in its original blister pack, protect it from light, and do not freeze it.

Keep the spray out of the reach of children and pets, and do not use it after the expiration date printed on the package.

Disposal
After use, place the empty nasal spray device and blister pack back in the carton or a small bag and discard them in the household trash where children and pets cannot reach them.

For unused or expired devices, use a community drug take-back program if available, or follow pharmacist or local guidance for safe disposal; do not flush medicines down the toilet unless specifically instructed.