Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Diazepam Intensol
  2. Valium

Descriptions


Diazepam is used to relieve symptoms of anxiety and alcohol withdrawal. This medicine may also be used to treat certain seizure disorders and help relax muscles or relieve muscle spasm. Diazepam buccal film is used as short-term treatment for seizure clusters (also known as acute repetitive seizures) in patients 2 to 5 years of age. Diazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet
  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diazepam tablets and oral liquid in children younger than 6 months of age. Safety and efficacy have not been established. Use of diazepam is not recommended in children younger than 6 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of diazepam buccal film in children younger than 2 years of age and older than 5 years of age. Safety and efficacy have not been established. Diazepam buccal film should not be used in newborns or infants.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazepam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving diazepam.

Use of diazepam buccal film is not recommended in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Flumazenil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abametapir
  • Alfentanil
  • Alprazolam
  • Amobarbital
  • Anileridine
  • Aprepitant
  • Aripiprazole
  • Benzhydrocodone
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Calcifediol
  • Calcium Oxybate
  • Cannabidiol
  • Cannabis
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Cetirizine
  • Chloral Hydrate
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Cobicistat
  • Codeine
  • Conivaptan
  • Dabrafenib
  • Dantrolene
  • Daridorexant
  • Dexmedetomidine
  • Diacetylmorphine
  • Difenoxin
  • Dihydrocodeine
  • Diphenoxylate
  • Doxylamine
  • Esketamine
  • Eslicarbazepine Acetate
  • Ethchlorvynol
  • Ethylmorphine
  • Etravirine
  • Fedratinib
  • Fentanyl
  • Fexinidazole
  • Flibanserin
  • Fluconazole
  • Fluvoxamine
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Fospropofol
  • Gabapentin
  • Gabapentin Enacarbil
  • Hydrocodone
  • Hydromorphone
  • Itraconazole
  • Ivacaftor
  • Ketamine
  • Ketobemidone
  • Lacosamide
  • Lemborexant
  • Levocetirizine
  • Levorphanol
  • Lofexidine
  • Lonafarnib
  • Loxapine
  • Magnesium Oxybate
  • Mavacamten
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Metoclopramide
  • Midazolam
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Netupitant
  • Nicomorphine
  • Olanzapine
  • Oliceridine
  • Omaveloxolone
  • Omeprazole
  • Opium
  • Opium Alkaloids
  • Orlistat
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Pentazocine
  • Pentobarbital
  • Periciazine
  • Phenobarbital
  • Phenytoin
  • Piritramide
  • Potassium Oxybate
  • Pregabalin
  • Primidone
  • Propofol
  • Remifentanil
  • Remimazolam
  • Ropeginterferon Alfa-2b-njft
  • Scopolamine
  • Secobarbital
  • Sodium Oxybate
  • Sparsentan
  • Sufentanil
  • Tapentadol
  • Thiopental
  • Tilidine
  • Topiramate
  • Tramadol
  • Trazodone
  • Zolpidem
  • Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amitriptyline
  • Amprenavir
  • Dalfopristin
  • Desogestrel
  • Dienogest
  • Disulfiram
  • Drospirenone
  • Erythromycin
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Fluoxetine
  • Gestodene
  • Ginkgo
  • Isoniazid
  • Levonorgestrel
  • Mestranol
  • Nomegestrol
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Quinupristin
  • Rifapentine
  • Roxithromycin
  • St John's Wort
  • Theophylline
  • Troleandomycin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol or drug use disorder or dependence, or history of or
  • Depression, or history of or
  • Lung or breathing problems (eg, respiratory depression) or
  • Mental health problems, or history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Breathing problems, severe or
  • Glaucoma, narrow-angle or
  • Liver disease, severe or
  • Myasthenia gravis or
  • Sleep apnea (temporary stopping of breathing during sleep)—Should not be used in patients with these conditions.
  • Kidney disease or
  • Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it.

To use the oral solution:

  • Measure the oral liquid with the medicine dropper that comes from the package.
  • Mix each dose with water, juice, soda or a soda-like beverage before you take it. You may also mix the liquid with a semisolid food such as applesauce or pudding.
  • Take the entire mixture right away. It should not be saved to use later.

To use the buccal film:

  • Family members, caregivers, and others should be taught on how to give this medicine in case a seizure cluster happens.
  • Make sure your hands are clean and dry before handling this medicine so the film does not stick to your fingers.
  • Open the pouch and remove the film. Fold the foil pouch along the solid line. Check where the vertical slit is and carefully tear down the side of the pouch at the slit along the arrow to open the pouch.
  • Remove the medicine from the foil pouch. Stretch either cheek open with one hand and place one film flat against the cheek with your other hand. Do not rub the film into the cheek with your finger. Place the film directly onto the inside of the cheek. Do not place it on the teeth.
  • Remove fingers from the cheek. If the film is spit out or blown out immediately, give another dose using a new film. Do not give this medicine with liquids.
  • Allow the film to dissolve. Do not give another dose if the film is swallowed or chewed.
  • The film will stick to the inside of the cheek and begin to dissolve. Saliva may be swallowed normally while the film dissolves.
  • Take note of the time you first gave the dose and changes in the resting breath rate.
  • Do not give a second dose if you are concerned about the child's breathing, an emergency rescue treatment with breathing help is needed, or there is more sleepiness than normal.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (solution or tablets):
    • For anxiety:
      • Adults—2 to 10 milligrams (mg) 2 to 4 times a day.
      • Older adults—At first, 2 to 2.5 mg 1 or 2 times a day. Your doctor may increase your dose if needed.
      • Children 6 months of age and older—At first, 1 to 2.5 mg 3 or 4 times per day. Your child's doctor may increase the dose if needed.
      • Children up to 6 months of age—Use is not recommended.
    • For alcohol withdrawal:
      • Adults—10 milligrams (mg) 3 or 4 times for the first 24 hours, then 5 mg 3 to 4 times per day as needed.
      • Older adults—At first, 2 to 2.5 mg 1 or 2 times a day. Your doctor will gradually increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For muscle spasm:
      • Adults—2 to 10 milligrams (mg) 3 or 4 times a day.
      • Older adults—At first, 2 to 2.5 mg 1 or 2 times a day. Your doctor may increase your dose if needed.
      • Children 6 months of age and older—At first, 1 to 2.5 mg 3 or 4 times per day. Your child's doctor may increase the dose if needed.
      • Children up to 6 months of age—Use is not recommended.
    • For seizures:
      • Adults—2 to 10 milligrams (mg) 2 to 4 times a day.
      • Older adults—At first, 2 to 2.5 mg 1 or 2 times a day. Your doctor may increase your dose if needed.
      • Children 6 months of age and older—At first, 1 to 2.5 mg 3 or 4 times per day. Your child's doctor may increase the dose if needed.
      • Children up to 6 months of age—Use is not recommended.
  • For buccal dosage form (film):
    • For seizure clusters:
      • Children 2 to 5 years of age—Dose is based on body weight and must be determined by your doctor. If a second dose is needed, it may be given at least 4 hours after the first dose. Do not use more than 2 doses to treat a single episode. Do not use this medicine for more than 1 episode every 5 days or more than 5 episodes per month.
        • Weighing 26 kilograms (kg) to 30 kg—15 milligrams (mg) per episode.
        • Weighing 21 kg to 25 kg—12.5 mg per episode.
        • Weighing 16 kg to 20 kg—10 mg per episode.
        • Weighing 11 kg to 15 kg—7.5 mg per episode.
        • Weighing 6 kg to 10 kg—5 mg per episode.
      • Children younger than 2 years of age or older than 5 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to see if the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause respiratory depression, a serious breathing problem that can be life-threatening, when used together with opioid pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficult or trouble breathing, or irregular, fast or slow, or shallow breathing.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Also, this medicine may cause double vision or other vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you or your child stop using this medicine. Check with your doctor before taking any of the above while you or your child are using this medicine.

If you or your child develop any unusual or strange thoughts and behavior while taking diazepam, be sure to discuss it with your doctor. Some changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

Do not change or suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, including hallucinations, seizures, stomach or muscle cramps, sweating, tremors, or unusual behavior.

Symptoms of an overdose include: change or loss of consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, irregular, fast or slow, or shallow breathing, lack of coordination, loss of strength or energy, muscle pain or weakness, pale or blue lips, fingernails, or skin, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, sweating, trouble breathing, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

This medicine contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Discuss this with your doctor if you are concerned.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Shakiness and unsteady walk
  2. unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

  1. Agitation
  2. black, tarry stools
  3. blistering, flaking, or peeling of the skin
  4. blurred vision
  5. changes in patterns and rhythms of speech
  6. changes in vision
  7. chills
  8. confusion
  9. cough
  10. dark urine
  11. decrease in the frequency of urination
  12. decrease in urine volume
  13. difficulty in passing urine (dribbling)
  14. discouragement
  15. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  16. false beliefs that cannot be changed by facts
  17. fast heartbeat
  18. fast or irregular breathing
  19. feeling sad or empty
  20. feeling that others are watching you or controlling your behavior
  21. feeling that others can hear your thoughts
  22. feeling, seeing, or hearing things that are not there
  23. fever
  24. headache
  25. hyperexcitability
  26. increased muscle spasms or tone
  27. irritability
  28. itching or rash
  29. lack of memory of what takes place after a certain event
  30. loss of appetite
  31. loss of bladder control
  32. loss of interest or pleasure
  33. loss of vision
  34. lower back or side pain
  35. nausea
  36. nightmares
  37. outbursts of anger
  38. painful or difficult urination
  39. pale skin
  40. restlessness
  41. seizures
  42. slurred speech
  43. sore throat
  44. stomach pain
  45. sweating
  46. trouble concentrating
  47. trouble sleeping
  48. trouble speaking
  49. ulcers, sores, or white spots in the mouth
  50. unpleasant breath odor
  51. unusual behavior
  52. unusual bleeding or bruising
  53. unusual feeling of excitement
  54. unusual tiredness or weakness
  55. vomiting of blood
  56. yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Agitation
  2. change in consciousness
  3. changes in patterns and rhythms of speech
  4. confusion
  5. difficult or trouble breathing
  6. excitement
  7. irregular, fast or slow, or shallow breathing
  8. irritability
  9. lack of coordination
  10. loss of consciousness
  11. loss of strength or energy
  12. muscle pain or weakness
  13. pale or blue lips, fingernails, or skin
  14. restlessness
  15. shakiness and unsteady walk
  16. sleepiness
  17. unsteadiness, trembling, or other problems with muscle control or coordination
  18. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  1. Constipation
  2. decreased interest in sexual intercourse
  3. diarrhea
  4. difficulty with swallowing
  5. double vision
  6. dry mouth
  7. feeling of constant movement of self or surroundings
  8. inability to have or keep an erection
  9. increase in sexual ability, desire, drive, or performance
  10. increased interest in sexual intercourse
  11. increased watering of the mouth
  12. indigestion
  13. loss of sexual ability, desire, drive, or performance
  14. passing of gas
  15. seeing double
  16. sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: June 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/diazepam-oral-route/proper-use/drg-20072333