Libervant

Pronunciation: lee-ber-vant
Generic name: diazepam
Dosage form: oral film for buccal use
Drug class: Benzodiazepine anticonvulsants

Medically reviewed by Carmen Pope, BPharm. Last updated on May 1, 2024.

What is Libervant?

Libervant (diazepam) is an oral benzodiazepine film that may be used short-term to treat children aged 2 to 5 years with seizure clusters (also known as “acute repetitive seizures”) that are different from their usual seizure pattern. Libervant is placed on the inside of a child’s cheek (buccally).

The way Libervant (diazepam) treats seizure clusters is not fully understood but is thought to involve enhancing GABA, an inhibitory neurotransmitter, because diazepam binds at the benzodiazepine site of the GABA_A receptor.

Libervant is a federally controlled substance (C-IV) because it contains diazepam that can be abused or lead to dependence. Keep it in a safe place to prevent misuse and abuse. Selling or giving it away may harm others and is against the law.

Libervant was FDA approved on April 26, 2024. Diazepam has been approved since November 15, 1963.

Libervant side effects

Libervant may cause serious side effects, including breathing problems, severe drowsiness, and withdrawal symptoms on discontinuation (see warnings below).

The most common side effects of Libervant affecting more than 4% of people taking it are sleepiness and headache.

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

Warnings

Libervant is a benzodiazepine medicine. 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 help right away if any of the following happens:

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

Do not allow your child to operate machinery or ride a bicycle until you know how Libervant affects your child.

The unapproved use of Libervant has a risk for abuse, misuse, and addiction, 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 Libervant). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest emergency room immediately if you get any serious side effects.

Your child can develop an addiction even if your child takes Libervant as prescribed by your child’s healthcare provider.

Give it exactly as your child’s healthcare provider prescribed. Do not give more than prescribed.

Do not share Libervant with other people.

Keep it in a safe place and away from children.

Benzodiazepines, including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use.

Do not suddenly stop giving Libervant to your child without talking to your child’s healthcare provider. Stopping Libervant suddenly can cause serious and life-threatening withdrawal effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest emergency room immediately if your child gets 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 child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction.
Do not give your child more Libervant than prescribed or give it more often than prescribed.

Libervant can make your child sleepy or dizzy and can slow your child’s thinking and motor skills.

Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child’s sleepiness or dizziness much worse.

Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500. Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you:

Thoughts about suicide or dying, or attempts to commit suicide
New or worse depression, anxiety, or irritability
Feeling agitated or restless or an extreme increase in activity and
Talking (mania)
Trouble sleeping (insomnia)
Acting aggressive, being angry, or violent
New or worse panic attacks
Other unusual changes in behavior or mood
Acting on dangerous impulses.

Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your child’s healthcare provider as scheduled.

Call your child’s 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 your child has suicidal thoughts or actions, your child’s healthcare provider may check for other causes.

It is unknown if Libervant is safe and effective in children less than 2 years of age and over 5 years of age.

Before taking

Do not give Libervant to your child if your child:

Is allergic to diazepam or any of the ingredients in Libervant
Has an eye problem called acute narrow-angle glaucoma.

Before you give Libervant, tell your child’s healthcare provider about all of your child’s medical conditions, including if your child:

has a history of depression, mood problems, or suicidal thoughts or behavior
has liver or kidney problems
has asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems

How should I give Libervant?

Read the Instructions for Use provided by your healthcare provider. Give Libervant exactly as your child’s healthcare provider tells you to. Do not change your child’s dosage unless your child’s healthcare provider tells you to change.

As the caregiver, before giving Libervant you must:

Be able to tell the difference between cluster seizures and ordinary seizures
Be comfortable in your ability to give Libervant the right way as instructed by your healthcare provider.

Your child’s healthcare provider will tell you:

What seizure clusters are
Exactly how much Libervant to give to your child
When and how to give Libervant
What you should do after you give Libervant if the seizures do not stop or if there is a change in breathing, behavior, or in their condition.

Libervant administration

You should carry Libervant with you in case you need to give it to treat your child’s seizure clusters. Before a seizure cluster happens, family members, caregivers, and other people who may have to give Libervant should know where you keep it and how to give it.

Each Libervant film comes in a sealed foil pouch. Do not open the foil pouch until you are ready to use it.
Do not split Libervant. The entire film should be placed on the inside of the cheek. Do not give with liquids. It does not matter if the child has recently eaten.
Stretch the side of one of your child’s cheeks open with one hand and place one film flat against the cheek with your other hand and leave it there. Do not rub the film into the cheek with your finger.
Place the film directly onto the inside of the cheek. Do not place film on teeth.
If the film is spit out or blown out immediately, attempt to give another dose using a new film. If you cannot give the dose, call for emergency help.
Allow time for the Libervant to dissolve. The film is not meant to be chewed or swallowed.

What should I do after Libervant has been given?

Note the time that you gave Libervant and any changes in your child’s resting breathing rate.

Call for emergency medical help if any of the following happens:

The seizures are different from other episodes your child has had
You are alarmed by how often the seizure happens, by how severe it is, by how long it lasts, or seizure is alarming
Your child is an unusual color or has unusual breathing.

Libervant dosage

The recommended dosage of Libervant is based on your child’s weight.

Libervant film is available in 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg strengths.
The usual dose is one Libervant film when your child has an unusual seizure cluster.

Your child’s healthcare provider may prescribe a second dose of Libervant. Only give it if they have told you to do so.

If a second dose is needed, it may be given at least 4 hours after the first dose of Libervant film is given.
Do not give more than 2 doses of Libervant to treat a seizure cluster.

Do not give a second dose of Libervant if:

you are concerned about your child’s breathing
an emergency rescue treatment with breathing help is needed
there is more sleepiness than normal.

Maximum Libervant dosage

Do not use Libervant for:

more than 1 seizure cluster episode every 5 days and
more than 5 episodes each month.

Talk to your child’s healthcare provider about slowly stopping Libervant to avoid withdrawal symptoms.

What happens if I miss a dose?

Since Libervant is just administered to a child when they have unusual seizure clusters, it generally does not matter if you miss a dose. Talk to your healthcare provider about this.

What happens if I overdose?

If you give your child too much Libervant, call your child’s healthcare provider or go to the nearest hospital emergency room right away.

What other drugs will affect Libervant?

Taking Libervant with certain other medicines can cause side effects or affect how well it works. Do not start or stop other medicines without talking to your child’s healthcare provider. Tell your child’s healthcare provider about all your child's medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not give other drugs, such as sedating antihistamines, that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider.

This is not a complete list of Libervant interactions. See the Libervant Package Insert for a full list.

Storage

Store Libervant at room temperature between 68°F to 77°F (20°C to 25°C). Keep it in its foil pouch until ready to use.

Keep out of reach of children.

Ingredients

Active ingredient: diazepam

Inactive ingredients: benzyl alcohol, clove oil, EDTA disodium salt, FD&C Green #3, glycerol monooleate, hypromellose, peppermint oil, polyethylene oxide, polyvinylpyrrolidone, sodium phosphate, sucralose, vanillin, xanthan gum, water, and white ink