Diazepam Nasal

How to take:

• Each device can be used once
• A person can give the nasal spray to themselves if they are not having a seizure at the time. If the medicine is meant to be given during or after a seizure, a family or care partner should be taught how to use it.
• Hold the nasal spray with one finger on each side of the nozzle. Do not prime the pump or push it in until it is ready to be used. 
• Place the nozzle in one nostril or side of the nose and push the plunger in to give the medicine. Remove the nasal spray device.
  • If 2 nasal sprays are needed for the 15 or 20 mg doses, give one spray into each side of the nose. 
• ​Follow the providers orders for observing the person afterwards. Watch for continued seizures and side effects. 
• If a second dose is needed for more seizures, it can be given 4 hours or more after the first dose.
• Do not use more the 2 doses of Valtoco for one seizure cluster. 
• It is recommended that Valtoco not be used more often than every 5 days or more than 5 times a month. 
• Talk to your treating provider if more frequent use seems needed.

How to store:

• Keep the medicine in a place that is easy to get when it is needed. 
• Keep them in their original container tightly closed, away from light, and out of reach of children. 
• Store your prescription at room temperature away from excess heat and moisture (i.e. not the bathroom). 
• Throw away any medication that is outdated or no longer needed.

These medicines are designed to be used only if needed as a rescue treatment. They are not designed to be used daily, and should not replace a patients daily anti-seizure medication. Do not take an extra dose unless prescribed by your doctor.

The exact way that diazepam works to stop seizures is not known. It appears to suppress or stop seizure activity by affecting a substance in the brain called GABA (gamma-aminobutyric acid). 

• Valtoco is well absorbed from the nose. It reaches peak or highest amounts in the bloodstream in 1.5 hours but starts working sooner. 
• Diazepam has a half-life in adults of about 49 hours. This means that it may stay at a level in the body that can help seizures for about 2 days. 
• In children, nasal diazepam has a half-life of 15 to 21 hours.
• Most of the diazepam is bound to proteins in the blood stream.
• Diazepam is broken down in the liver to metabolites or breakdown products that can also have effects on seizures. 

• The way it worked in the body was similar for Diastat and Valtoco. 
• In a long term study that evaluated how well people did taking Valtoco, the majority of people only needed one dose of Valtoco. 
  • 96% of people by 4 hours 
  • 94%  of people by 6 hours
  • 91% of people by 12 hours
  • 86% of people over 24 hours

Approval of Valtoco was based primarily upon the drugs bioavailability compared to Diastat. In these studies, the systemic exposure (AUC) and maximal peak concentrations (Cmax) of diazepam was similar between Diastat and  Valtoco. Safety of Valtoco in pediatric patients was also confirmed in open-label studies. With regard to how well Valtoco works, both safety and efficacy were established based primarily upon studies done with Diastat.

The most frequent side effect of Diastat is sleepiness. Other reported side effects include:

• Dizziness
• Headache
• Pain
• Nervousness
• Diarrhea
• Unsteady walking
• Behavior change
• Poor coordination
• Asthma
• Runny nose
• Rash (2 to 5 %)
• Vasodilation (light-headedness from low blood pressure may occur)

• Feeling sleepy or drowsy
• Headache
• Nose discomfort or congestion

• Usually the benefits of Diastat far outweigh the mild to moderate side effects.
• Side effects generally go away within hours, and with no lasting harm. 
• Serious problems are very rare.

Breathing Problems:

• People given diazepam by injection occasionally need help with breathing, especially if they have other breathing problems or have taken sedating medicines.
• Breathing problems are extremely rare when either Diastat or Valtoco are used. The risk is slightly higher when more than one dose is given.
• Caregivers should watch for signs of breathing problems (for example, slowed breathing or a change in the color of the skin) and call for help if needed. 

Central Nervous System Depression

All benzodiazepines can cause CNS depression which means it affects how the brain may work.

• For example, the medicines may cause drowsiness, affect alertness and thinking. 
• If a person feels very sleepy, dizzy or uncoordinated for a period after using one of these medicines, they should avoid activities where they could get injured.

Suicidal Thoughts and Behavior

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10.

Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions:

• Do not make any changes to the medication regimen without first talking with the responsible healthcare professional.
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.

Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:

• Talking or thinking about wanting to hurt yourself or end your life
• Withdrawing from friends and family
• Becoming depressed or having your depression get worse
• Becoming preoccupied with death and dying
• Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Changes in Vision (Glaucoma): Diazepam may cause an increase in eye pressure in people with open-angle glaucoma. 

Other potentially serious side effects: Increased seizure tolerance

• Some people with epilepsy who take diazepam or other benzodiazepines daily may have more frequent or severe seizures if the medicine is lowered or stopped. 
• Developing tolerance and needing a higher dose to get the same effect could also be a problem with daily diazepam. 
• Since Diastat and Valtoco are not used daily, these concerns are much less likely to arise. 

Nothing listed.

Valtoco is only approved for treatment of seizure clusters.

• People with a known sensitivity to diazepam.
• People who have an eye condition called acute narrow angle glaucoma. People with open angle glaucoma may use it.

Caution needs to be taken when taking any diazepam product with alcohol, pain medications and other antianxiety medications.

See package insert.

See package insert.

Extra caution is needed when diazepam is used in older adults or those with liver or kidney disease. The medicine may last longer in their body and could lead to higher amounts of medicine in the body. They may be more likely to develop side effects like drowsiness, unsteadiness, or breathing problems.

See package insert

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Diastat (diazepam) is found at:In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Valtoco (diazepam) is found at:

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211635s000lbl.pdf

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see "How to read a package insert."