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Estazolam (Oral route)

Pronunciation:

es-TAZ-oh-lam

Brand Names:

  • Prosom

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Hypnotic

Pharmacologic—

Benzodiazepine, Short or Intermediate Acting

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast-feeding—

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.

Other medicines—

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 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
  • Amobarbital
  • Anileridine
  • Aprobarbital
  • Butabarbital
  • Butalbital
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlorzoxazone
  • Codeine
  • Dantrolene
  • Ethchlorvynol
  • Fentanyl
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Levorphanol
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Morphine
  • Morphine Sulfate Liposome
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Phenobarbital
  • Primidone
  • Propoxyphene
  • Remifentanil
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Thiopental
  • 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.

  • Perampanel
  • 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 abuse, or history of, or
  • Drug abuse or dependence, or history of—Dependence on estazolam may develop.
  • 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 of This Medicine:

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.

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.

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 While Using This Medicine:

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 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.

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 such as 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 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.

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, such as convulsions (seizures), hallucinations, 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.

Side Effects of This Medicine:

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
Absence of or decrease in body movement
clumsiness or unsteadiness
dizziness
sleepiness or unusual drowsiness
Less common
Delusions
dementia
dry mouth
headache
mood or mental changes
nausea and vomiting
tiredness
Rare
Aggressive or angry
blood in the urine
bloody nose
bloody, black, or tarry stools
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain
chills
convulsions
cough
crying
decrease in the amount of urine
decreased awareness or responsiveness
decreased reflexes
deep or fast breathing with dizziness
depersonalization
difficult or labored breathing
difficult urination
difficulty breathing
dryness or soreness of throat
dysphoria
fainting
false or unusual sense of well-being
fast, irregular, pounding, or racing heartbeat or pulse
fear or nervousness
feeling of warmth
fever
frequent strong or increased urge to urinate
hoarseness
increased urge to urinate during the night
irritability
lack of feeling or emotion
loss of bladder control
loss of memory
mouth sores or ulcers
muscle spasm or jerking of all extremities
noisy breathing
numbness of the feet, hands, and around mouth
paranoia
problems with memory
quick to react or overreact emotionally
rapidly changing moods
redness of the face, neck, arms, and occasionally, upper chest
restlessness
seeing, hearing, or feeling things that are not there
severe sleepiness
severe stomach pain
shakiness and unsteady walk
shakiness in the legs, arms, hands, or feet
shortness of breath
skin rash
sores, ulcers, or white spots on the lips or in the mouth
sudden loss of consciousness
swelling
swollen glands
swollen lymph nodes
tightness in the chest
trouble in swallowing
trouble sleeping
uncaring
uncontrolled eye movements
unsteadiness, trembling, or other problems with muscle control or coordination
unusual bleeding or bruising
unusual tiredness or weakness
voice changes
waking to urinate at night
wheezing
Incidence not known
Blistering, peeling, or loosening of the skin
diarrhea
fever with or without chills
general feeling of tiredness or weakness
itching
joint or muscle pain
lower back or side pain
muscle cramps
red, irritated eyes
red skin lesions, often with a purple center
sleeplessness
sweating
unable to sleep

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
Lack or loss of strength
Less common
Pain in the legs or feet
Rare
Blemishes on the skin
bloated
blurred vision
burning feeling in the chest or stomach
change in color vision
change in taste bad unusual or unpleasant (after) taste
changes in vision, especially night blindness
continuing ringing or buzzing or other unexplained noise in the ears
cramping in the lower abdomen, back, or legs
decreased interest in sexual intercourse
difficulty having a bowel movement (stool)
difficulty in moving
difficulty seeing at night
double vision
ear or eye pain
excess air or gas in stomach or intestines
full feeling
glare or snowy image caused by bright light
hearing loss
hives or welts
inability to have or keep an erection
increased or decreased appetite
increased sensitivity of eyes to sunlight
indigestion
loss in sexual ability, desire, drive, or performance
muscle pains or stiffness
pain in the arms, jaw, or neck
pain or tenderness around the eyes and cheekbones
pain, swelling, or redness in joints
passing gas
pimples
red, sore eyes
redness of the skin
seeing double
sneezing
stomach upset
stuffy or runny nose
swelling of the breasts
tenderness in stomach area
weight gain or loss
white or brownish vaginal discharge
Incidence not known
Increased sensitivity of skin to sunlight
redness or other discoloration of skin
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.


Last Updated: 4/4/2014

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