Valtoco, illustration of nasal spray form (not a photo of the actual pack)

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Valtoco

Diazepam

Prescription required

$1311.00

5mg · 1

BrandBranded medicine· By Neurelis

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FDA boxed warningRisks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.

The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO.

The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.

Read this with the rest of the clinical information

About Valtoco

Overview

Valtoco is a nasal spray containing diazepam, a benzodiazepine anticonvulsant. It is used for the acute treatment of seizure clusters, episodes of frequent seizures that differ from a person’s usual seizure pattern, in people with epilepsy aged 2 years and older. Its exact action is not fully understood, but it is thought to enhance the effects of GABA, a chemical messenger in the brain.

What it treats

Acute treatment of seizure clusters (acute repetitive seizures) that are distinct from the usual seizure pattern in people with epilepsy aged 2 years and older.

Safety information

Side effects

Common side effects of Valtoco include sleepiness, headache and nasal discomfort. Contact a doctor promptly about excessive sleepiness or reduced alertness, or concerns about abuse, misuse, addiction, dependence or withdrawal. Dependence and withdrawal reactions can occur when Valtoco is used more frequently than recommended. Using it with opioids carries a risk of serious adverse reactions. Alcohol and other medicines that slow brain activity can increase its sedating effects. Seek urgent medical help for suicidal thoughts or behavior. Valtoco can increase pressure inside the eye in people with glaucoma; people with open-angle glaucoma should use it only while receiving appropriate treatment. Use during pregnancy can cause sedation or withdrawal in the newborn. The benzyl alcohol preservative also carries a risk of serious adverse reactions in infants. Discuss these risks with a doctor.

FDA boxed warning

Risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.

The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO.

The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

• Seek medical help immediately for extreme sleepiness, slowed breathing, or loss of consciousness, especially when Valtoco is used with opioid medicines. • Seek medical help immediately for thoughts of suicide or suicidal behavior.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not use Valtoco if you have a known allergy to diazepam or acute narrow-angle glaucoma. Valtoco can increase pressure inside the eye. People with open-angle glaucoma may use it only if they are receiving appropriate treatment for their glaucoma. Valtoco can reduce alertness and cause sedation. Alcohol and other medicines that slow brain activity may increase these effects. Monitoring is needed for these effects and for suicidal thoughts or behavior. Use during pregnancy requires caution. Animal data suggest possible harm to the unborn baby, and use during pregnancy can cause sedation or withdrawal symptoms in the newborn.

Interactions

Medicines that inhibit the enzymes CYP2C19 or CYP3A4 may slow the removal of diazepam from the body, increasing the risk of side effects from Valtoco. Medicines that increase the activity of these enzymes may reduce diazepam exposure, making Valtoco less effective. Ask your doctor whether any medicines you take affect these enzymes.

Using Valtoco

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C upright, away from direct light. Do not freeze. Follow the in-use period printed on the pack once it is opened. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label VALTOCO (DIAZEPAM) SPRAY [NEURELIS, INC] (DailyMed, retrieved 19 September 2026).

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