Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Prosom

Descriptions


Estazolam is used to treat insomnia (trouble with sleeping). This medicine is for short-term use only, usually 7 to 10 days. Estazolam 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

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 estazolam in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of estazolam in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, which may require an adjustment in the dose for patients receiving estazolam.

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.

  • Alfentanil
  • Alprazolam
  • Amobarbital
  • Benzhydrocodone
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Calcium Oxybate
  • Cannabidiol
  • Carbinoxamine
  • Carisoprodol
  • Cetirizine
  • Chloral Hydrate
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Cobicistat
  • Codeine
  • Dantrolene
  • Dihydrocodeine
  • Doxylamine
  • Esketamine
  • Ethchlorvynol
  • Fentanyl
  • Flibanserin
  • Fospropofol
  • Gabapentin
  • Gabapentin Enacarbil
  • Hydrocodone
  • Hydromorphone
  • Ketamine
  • Lemborexant
  • Levocetirizine
  • Levorphanol
  • Lofexidine
  • Loxapine
  • Magnesium Oxybate
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Metoclopramide
  • Midazolam
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Pentobarbital
  • Periciazine
  • Phenobarbital
  • Potassium Oxybate
  • Pregabalin
  • Primidone
  • Propofol
  • Remimazolam
  • Scopolamine
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Thiopental
  • Tramadol
  • Trazodone
  • Zolpidem

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.

  • Rifapentine
  • St John's Wort
  • Theophylline

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.

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 abuse or dependence, or history of, or
  • Breathing problems or lung disease, severe or
  • Depression, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—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).

Take estazolam just before going to bed, when you are ready to go to sleep.

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

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 form (tablets):
    • For insomnia:
      • Adults—At first, 1 milligram (mg) at bedtime. Your doctor may adjust your dose if needed.
      • Older adults—At first, 0.5 milligram (mg) at bedtime. Your doctor may adjust your dose if needed.
      • Children—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.

Use this medicine only when you cannot sleep. You do not need to keep a regular dosage schedule for taking it.

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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away. Do not breastfeed while you are using this medicine.

Do not take itraconazole (Sporanox®) or ketoconazole (Nizoral®) while you are using this medicine. Taking these medicines together with estazolam may increase the chance of serious side effects.

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.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, or less alert than they are normally. Even though estazolam is taken at bedtime, it may cause some people to feel drowsy or less alert the next morning. Make sure you know how you react to estazolam before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to think or see well.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Symptoms of an overdose include: change in consciousness, difficult or trouble breathing, difficulty with coordination, irregular, fast or slow, or shallow breathing, loss of consciousness, mood or mental changes, pale or blue lips, fingernails, or skin, sleepiness or unusual drowsiness, or slurred speech. Call your doctor right away if you notice these symptoms.

If you develop any unusual or strange thoughts and behavior while taking estazolam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other 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.

This medicine may cause sleep-related behaviors including driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while you are asleep or not fully awake. If these reactions occur, tell your doctor right away.

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

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you 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, tremors, or unusual behavior.

Avoid smoking while you are using this medicine.

If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor.

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. Absence of or decrease in body movement
  2. clumsiness or unsteadiness
  3. dizziness
  4. sleepiness or unusual drowsiness

Less common

  1. Dry mouth
  2. false beliefs that cannot be changed by facts
  3. headache
  4. mood or mental changes
  5. nausea and vomiting
  6. poor insight and judgment
  7. problems with memory or speech
  8. tiredness
  9. trouble thinking and planning
  10. trouble walking

Rare

  1. Aggressive or angry
  2. blood in the urine
  3. bloody nose
  4. bloody, black, or tarry stools
  5. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  6. chest pain or tightness
  7. chills
  8. cough
  9. crying
  10. decrease in the amount of urine
  11. decreased awareness or responsiveness
  12. decreased reflexes
  13. deep or fast breathing with dizziness
  14. difficult urination
  15. dryness or soreness of throat
  16. dysphoria
  17. fainting
  18. false or unusual sense of well-being
  19. fast, irregular, pounding, or racing heartbeat or pulse
  20. fear or nervousness
  21. feeling of unreality
  22. feeling of warmth
  23. fever
  24. frequent strong or increased urge to urinate
  25. hoarseness
  26. increased urge to urinate during the night
  27. irritability
  28. lack of feeling or emotion
  29. loss of bladder control
  30. loss of memory
  31. mouth sores or ulcers
  32. muscle spasm or jerking of all extremities
  33. noisy breathing
  34. numbness of the feet, hands, and around mouth
  35. paranoia
  36. problems with memory
  37. quick to react or overreact emotionally
  38. rapidly changing moods
  39. redness of the face, neck, arms, and occasionally, upper chest
  40. restlessness
  41. seeing, hearing, or feeling things that are not there
  42. seizures
  43. sense of detachment from self or body
  44. severe sleepiness
  45. severe stomach pain
  46. shakiness and unsteady walk
  47. shakiness in the legs, arms, hands, or feet
  48. skin rash
  49. sores, ulcers, or white spots on the lips or in the mouth
  50. sudden loss of consciousness
  51. swelling
  52. swollen glands
  53. swollen lymph nodes
  54. trouble breathing
  55. trouble in swallowing
  56. trouble sleeping
  57. uncaring
  58. uncontrolled eye movements
  59. unsteadiness, trembling, or other problems with muscle control or coordination
  60. unusual bleeding or bruising
  61. unusual tiredness or weakness
  62. voice changes
  63. waking to urinate at night

Incidence not known

  1. Blistering, peeling, or loosening of the skin
  2. diarrhea
  3. fever with or without chills
  4. general feeling of tiredness or weakness
  5. itching
  6. joint or muscle pain
  7. lower back or side pain
  8. muscle cramps
  9. red, irritated eyes
  10. red skin lesions, often with a purple center
  11. sleeplessness
  12. sweating
  13. unable to sleep

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

Symptoms of overdose

  1. Change in consciousness
  2. irregular, fast or slow, or shallow breathing
  3. pale or blue lips, fingernails, or skin
  4. slurred speech

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:

More common

  1. Lack or loss of strength

Less common

  1. Pain in the legs or feet

Rare

  1. Blemishes on the skin
  2. bloated
  3. blurred vision
  4. burning feeling in the chest or stomach
  5. change in color vision
  6. change in taste bad unusual or unpleasant (after) taste
  7. changes in vision, especially night blindness
  8. continuing ringing or buzzing or other unexplained noise in the ears
  9. cramping in the lower stomach, back, or legs
  10. decreased interest in sexual intercourse
  11. difficulty having a bowel movement (stool)
  12. difficulty in moving
  13. difficulty seeing at night
  14. double vision
  15. ear or eye pain
  16. excess air or gas in stomach or intestines
  17. full feeling
  18. glare or snowy image caused by bright light
  19. hearing loss
  20. hives or welts
  21. inability to have or keep an erection
  22. increased or decreased appetite
  23. increased sensitivity of eyes to sunlight
  24. indigestion
  25. loss in sexual ability, desire, drive, or performance
  26. muscle pains or stiffness
  27. pain in the arms, jaw, or neck
  28. pain or tenderness around the eyes and cheekbones
  29. pain, swelling, or redness in joints
  30. passing gas
  31. pimples
  32. red, sore eyes
  33. redness of the skin
  34. seeing double
  35. sneezing
  36. stomach upset or tenderness
  37. stuffy or runny nose
  38. swelling of the breasts
  39. weight gain or loss
  40. white or brownish vaginal discharge

Incidence not known

  1. Increased sensitivity of skin to sunlight
  2. redness or other discoloration of skin
  3. severe sunburn

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.