The FDA announced that there is an ongoing shortage of both brand and generic forms of diazepam rectal gel. This medication is used for rescue therapy in people with epilepsy, including children. We strongly encourage you to speak with your healthcare provider about your/your child’s options for rescue therapy, since new FDA-approved rescue therapy products have entered the market.
Diastat (dye-ah-stat) is the brand name used in the United States and Canada for the seizure medicine with the generic name diazepam rectal gel. It is a seizure rescue medicine that is inserted into a person's rectum to stop a cluster of repeated seizures. Similar products are available in the UK and elsewhere.
Diazepam rectal gel is approved for use as a rescue medicine in people who have refractory seizures on stable doses of seizure medicines and need intermittment use of diazepam to control bouts of seizures.
- These terms may also refer to periods of increased seizures or seizure clusters
- Seizure clusters are times when there is a change in the number, pattern or type of seizures. These are often different from a person's usual seizures.
- Diastat rectal gel is prescribed for short-term treatment and does not take the place of daily seizure medicine.
Used to Treat
"Quick-Dose" rectal delivery system (resembling a syringe with a flexible, molded tip):
- Pediatric: 2.5 mg, 5 mg
- "Universal": 10 mg
- Adult: 15 mg, 20 mg
Frequently Asked Questions
How to take and store Diazepam Rectal?
Diazepam rectal gel comes in pre-filled syringes for rectal use in the following doses. Doses come in 2.5 mg, 5 mg, 7.5 mg, 10 mg each.
When they filled their prescription, patients or their caregivers should have received written instructions with pictures showing how to give Diastat. Caregivers should be encouraged to study these instructions carefully right away, so they are not trying to learn the steps during a medical emergency. They should understand the procedure and be comfortable with their role in administering the Diastat.
It is also important for the physician to explicitly state in writing the circumstances under which Diastat should be given to a particular patient, and to give these written instructions to all caregivers who may be administering Diastat to thatpatient. The instructions should also include what caregivers should look for after Diastat has been given and what to do if the patient condition does not improve as expected.
As shown above, Diastat is packaged in plastic applicators of various sizes, which contain different doses of diazepam. Each "Twin Pack" package contains devices for giving the medication two times. Diastat should be stored at room temperature and has a shelf life up to 3 years.
What if I forget?
Diastat rectal gel is not intended to be used every day. It should be kept in a place that is easy to remember so it's available when it's needed.
Always follow the instructions from your health care provider on when to use this medicine.
How does Diazepam Rectal affect the brain?
The exact way that diazepam works in the brain is unknown. It appears to suppress or stop seizures by inreasing the way a substance (gamma-aminobutyric acid or GABA) acts in the brain. GABA is a neurotransmitter inthe brain.
How does the body digest Diazepam Rectal?
- Diastat is well-absorbed after it is given rectally.
- It may start working in the brain between 5 and 30 minutes.
- It reaches peak amounts in the blood in 1.5 hours.
- The half-life drug is 46 hours or about 2 days.A half-life refers to how long it takes for the body to get rid of half of the drug.
- Most of diazepam and its metabolites or breakdown products are bound to proteins in the blood.
- It is broken down in the liver. They body gets rid of or eliminates the drug from the body through the urine.
What are the most common side effects of Diazepam Rectal?
Some common side-effects include:
- tired or sleepy
- poor coordination
- behavior changes
- blurred or double-vision
Write down any side effects that happen or are seen and tell your health care provider. Sometimes it is hard to tell if a side effect is due to a medicine or to the seizure(s).
What are the most serious side effects of Diazepam Rectal?
Usually the benefits of Diastat far outweigh its mild to moderate side effects, which generally go away within hours, and with no lasting harm. Serious problems are very rare.
Breathing Problems: These are very rare when Diastat is used. The greatest risk of slowed breathing is when a second dose is used, specially if the first dose was near the upper limit of what the person can tolerate.
- Caregivers should be alert for signs of breathing problems, such as slower breathing or a change in the color of the skin (skin may look bluish).
- The risk of breathing problems may be greater in older adults or people with other breathing problems.
- If the seizure has stopped but no breathing can be seen for more than 8 to 10 seconds, call emergency medical personnel (911, if available).
Use in older adults or people with liver or kidney disease: Extra caution is needed when using Diastat for seniors or those with liver or kidney disease. The drug may last longer in the body. If the drug is given to them too often, the amount in their body may be too high. This can cause more side effects.
Central nervous system (CNS) depression: In general, drugs like diazepam affect the CNS (the brain and spinal cord) and can cause sleepiness, dizziness, or poor coordination for a time after Diastat has been used.
- People should avoid doing things that could be dangerous, like riding a bicycle, after using diazepam if they are having any side effects.
- Some other medicines can increase side effects of diazepam - talk to your health care provider and pharmacist about any drug interactions.
- Alcohol or other substances that affect the brain, such as opioids used to treat severe pain, can worsen side effects of diazepam and should not be used at the same time.
Suicidal thoughts and behavior: Since 2008, the Food and Drug Administration (FDA) has placed a warning on seizure medicines (called AEDs) used for any reason. The FDA alert states that some seizure medicines may increase a person's risk for suicidal thoughts or behavior. Together these thoughts are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance - 3.5 of 1,000 people taking a seizure medicine had symptoms of suicidality compared to 1 of 1,000 people taking a placebo.
- Since diazepam rectal gel is being used intermittently for cluster seizures, the risk for suicidality would likely be rare.
- People taking any seizure medicine should talk to their provider about the following recommendations.
- Taking seizure medicines may increase the risk of suicidal thoughts or actions.
- Do not make any changes to the medicines without first talking to the prescribing health care provider.
- Stopping any seizure medicine suddensent could lead to worsening of seizures and mood.
- 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.
- Know common warning signs that might be a signal for risk of suicide,
- 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
Allergic reactions: Allergic reactions happen rarely, but can cause symptoms such as low blood pressure, hives, rash, breathing difficulties, and swelling. It can happen after the first dose or any time when taking the medicine. Since this can be life-threatening, get immedicate medical help if these symptoms occur.
Impact of Diazepam Rectal on bone health
At this time there is no evidence to support this medication causes bone health problems. Please see package insert.
What else is Diazepam Rectal used for?
- Severe anxiety and panic attacks
- Muscle relaxant
Who should not take Diazepam Rectal?
Diastat should not be given to people who have an eye condition called acute narrow angle glaucoma. People with open angle glaucoma may use it.
Extra caution is needed when considering the use of Diastat for seniors or those with liver or kidney disease. These people require longer to clear the medication from the body, so if Diastat is given to them too often, the level can become high and cause unwanted effects like drowsiness, unsteadiness, or breathing problems.
Can Diazepam Rectal be taken with other medicines?
Caution needs to be taken when taking diazepam with alcohol, pain medications and other antianxiety medications.
What are the effects of Diazepam Rectal on Children?
Read package insert
If a woman takes Diazepam Rectal during pregnancy will it hurt the baby?
Read package insert.
What are the effects of Diazepam Rectal on Seniors
Read package insert.
What are the dose ranges for Diazepam Rectal?
See advanced section.
Read the package insert of Diazepam Rectal
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:
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."
Primary Generalized Epilepsy