Pronunciation:

es-TAZ-oh-lam

Brand Names:

• Prosom

Dosage Forms:

• Tablet

Warnings:

Warning: Risks From Concomitant Use With Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal ReactionsConcomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, including estazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing estazolam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including estazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of estazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue estazolam or reduce the dosage .

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.

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 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
• Aripiprazole
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Cetirizine
• Chloral Hydrate
• Chlorzoxazone
• Clarithromycin
• Clobazam
• Clonazepam
• Cobicistat
• Codeine
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Dihydrocodeine
• Doxylamine
• Esketamine
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Ivacaftor
• Ketamine
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Metoclopramide
• Midazolam
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Pregabalin
• Primidone
• Propofol
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Thiopental
• 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.

• 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 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. 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 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 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 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

Dry mouth

false beliefs that cannot be changed by facts

headache

mood or mental changes

nausea and vomiting

poor insight and judgment

problems with memory or speech

tiredness

trouble thinking and planning

trouble walking

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 or tightness

chills

cough

crying

decrease in the amount of urine

decreased awareness or responsiveness

decreased reflexes

deep or fast breathing with dizziness

difficult urination

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 unreality

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

seizures

sense of detachment from self or body

severe sleepiness

severe stomach pain

shakiness and unsteady walk

shakiness in the legs, arms, hands, or feet

skin rash

sores, ulcers, or white spots on the lips or in the mouth

sudden loss of consciousness

swelling

swollen glands

swollen lymph nodes

trouble breathing

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

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

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

Symptoms of overdose

Change in consciousness

irregular, fast or slow, or shallow breathing

pale or blue lips, fingernails, or skin

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

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 stomach, 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 or tenderness

stuffy or runny nose

swelling of the breasts

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.