Valtoco

Pronunciation: val-toe-koe
Generic name: diazepam nasal spray
Dosage form: nasal spray (5 mg/0.1 mL, 7.5 mg/0.1 mL, 10 mg/0.1 mL)
Drug class: Benzodiazepine anticonvulsants

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 29, 2025.

What is Valtoco?

Valtoco is used for the short-term treatment of seizure clusters (also known as "acute repetitive seizures") that are different from a person's normal seizure pattern in adults and children aged 2 years and older. It is a nasal spray that is given as a single dose. If needed, a second dose can be given 4 hours later.

Valtoco (diazepam nasal spray) is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse. Selling or giving away this medicine may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription drugs, or street drugs.

Valtoco gained FDA approval on January 10, 2020. Oral diazepam has been approved since 1963.

Mechanism

The exact way Valtoco works is not known, but experts suggest it enhances the effects of GABA (a calming neurotransmitter) by attaching to specific binding sites on GABA_A receptors, strengthening inhibitory signals throughout the nervous system.

Valtoco belongs to the drug class called benzodiazepines.

Side effects

The most common side effects of Valtoco are:

• feeling sleepy or drowsy

• headache

• nose discomfort.

Serious side effects and warnings

Valtoco is a benzodiazepine medicine and carries a Boxed Warning for risks from concomitant use with opioids, abuse, misuse, addiction, dependence, and withdrawal reactions. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency medical help right away if any of the following happens:

• shallow or slowed breathing
• your breathing stops (which may lead to the heart stopping)
• excessive sleepiness (sedation).

Do not drive or operate heavy machinery until you know how taking Valtoco with opioids affects you.

Valtoco can cause the following serious side effects:

• Risk of abuse, misuse, and addiction. There is a risk for abuse, misuse, and addiction with benzodiazepines, including Valtoco, which can lead to overdose and serious side effects including coma and death.
  • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Valtoco). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
  • You can develop an addiction even if you use Valtoco as prescribed by your healthcare provider.
  • Use exactly as your healthcare provider prescribed.
  • Do not share with other people.
  • Keep in a safe place and away from children.
• Physical dependence and withdrawal reactions. Benzodiazepines, including Valtoco, can cause physical dependence and withdrawal reactions, especially if you use them daily. Valtoco is not intended for daily use.
  • Do not suddenly stop using Valtoco without talking to your healthcare provider. Stopping this medicine suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
  • Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
  • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • Do not use more than prescribed or use more often than prescribed.
• Valtoco can make you sleepy or dizzy and can slow your thinking and motor skills.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Valtoco affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while using Valtoco without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, this medicine may make your sleepiness or dizziness worse.
• Like other antiepileptic medicines, Valtoco may cause suicidal thoughts or actions in a small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • thoughts about suicide or dying
  • feeling agitated or restless
  • acting aggressively, being angry, or being violent
  • attempts to commit suicide
  • panic attacks
  • acting on dangerous impulses
  • trouble sleeping (insomnia)
  • an extreme increase in activity and talking (mania)
  • new or worse anxiety
  • new or worse irritability
  • other unusual changes in behavior or mood
  • new or worse depression.

How can I watch for early symptoms of suicidal thoughts or actions?

• • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

• Increase in eye pressure in people with open-angle glaucoma. Do not use Valtoco if you have acute narrow-angle glaucoma. 

It is not known if this medicine is safe and effective in children under 2 years of age.

These are not all of the possible side effects of Valtoco. Call your doctor for medical advice about side
effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking this medicine

Do not use Valtoco if you are allergic to diazepam (Valium), Valtoco, or if you have narrow-angle glaucoma.

To make sure this medicine is safe for you, tell your doctor about all your medical conditions, including if you:

• have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems
• have a history of alcohol or drug abuse
• have a history of depression, mood problems, or suicidal thoughts or behaviors
• have liver or kidney problems.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Some people have thoughts about suicide while using Valtoco. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

This medicine is not approved for use by anyone younger than 2 years old.

Pregnancy

May harm an unborn or newborn baby. Taking Valtoco late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone) and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).

Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with this medicine.

If you become pregnant while using Valtoco, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can register by calling 1-888- 233-2334. For more information about the registry, go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

Breastfeeding

Valtoco passes into your breast milk and may harm your baby.

Breastfeeding during treatment with this medicine may cause your baby to have sleepiness, feeding problems, and decreased weight gain.

How should I use Valtoco?

Valtoco is for use only in the nose.

Read the Instructions for Use for detailed information about the right way to use this medicine.

• Use exactly as prescribed by your healthcare provider 

Your healthcare provider will tell you:

• what seizure clusters are
• exactly how much to give
• when to give it
• how to give it
• what to do after you give Valtoco if the seizures do not stop or there is a change in breathing, behavior, or condition that worries you.

You should carry Valtoco with you in case you need it to control your seizure clusters.

Family members, care providers, and other people who may have to give this medicine should know where you keep your Valtoco and how to give it before a seizure cluster happens.

Valtoco is given in the nose (nasal) only.

• Do not test or prime the nasal spray before use.
• Each device only sprays 1 time and cannot be reused.
• Each dose of Valtoco is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.

What should I do after I give Valtoco?

Stay with the person after you give Valtoco and watch them closely.

• Make a note of the time this medicine was given.

Call for emergency help if any of the following happen:

• seizure cluster behavior is different than other seizure clusters the person has had.
• you are alarmed by how often the seizures happen, by how severe the seizure is, by how long the seizure lasts, or by the color or breathing of the person.

Throw away (discard) the used device.

• If needed, a second dose may be given at least 4 hours after the first dose, using a new pack of Valtoco. Do not give more than 2 doses to treat a seizure cluster.
• A second dose should not be given if there is concern about the person’s breathing, they need help with their breathing, or have extreme drowsiness.

Do not use for more than 1 seizure cluster episode every 5 days. Do not use for more than 5 seizure cluster episodes in 1 month.

Dosing information

The dosage of Valtoco is dependent on a person's age and weight.

The recommended number of nasal spray devices based on age and weight for adults and children 2 years and older are as follows:

Second Dose (if needed): A second dose, when required, may be administered at least 4 hours after the initial dose. If the second dose is to be administered, use a new Valtoco nasal spray device.

What happens if I overdose?

When treating a seizure cluster, the maximum is 2 doses of Valtoco per seizure cluster. Wait at least 5 days between treating seizure cluster episodes. Do not use for more than 5 seizure cluster episodes within a month.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

• Overdose symptoms may include drowsiness, confusion, muscle weakness, or loss of consciousness.

What should I avoid while using this medicine?

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how Valtoco will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What other drugs will affect this medicine?

Using Valtoco with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with diazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C).

• Do not freeze.
• Keep it in its blister pack until ready to use. Protect from light.
• Keep out of the reach of children.

Ingredients

Active ingredient: diazepam

Inactive ingredients: benzyl alcohol, dehydrated alcohol, n-dodecyl beta-D-maltoside, and vitamin E.

Valtoco is available in the following strengths:

• 5 mg/0.1 mL
• 7.5 mg/0.1 mL
• 10 mg/0.1 mL.

Manufacturer

Valtoco (diazepam nasal spray) is made by Neurelis, Inc. Their headquarters are located in San Diego, California.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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