Prosom

Generic Name: estazolam (Oral route)

es-TAZ-oh-lam

Commonly used brand name(s)

In the U.S.

• Prosom

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypnotic

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Uses For Prosom

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 Prosom

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies 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.

Interactions with 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


• Carisoprodol


• Chloral Hydrate


• Chlorzoxazone


• Codeine


• Dantrolene


• Ethchlorvynol


• Fentanyl


• Fospropofol


• Hydrocodone


• Hydromorphone


• Levorphanol


• 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.

• Theophylline

Interactions with Food/Tobacco/Alcohol

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 Prosom

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 Prosom

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.

Prosom 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

• 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.

See also: Prosom side effects (in more detail)

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More Prosom resources

• Prosom Side Effects (in more detail)
• Prosom Dosage
• Prosom Use in Pregnancy & Breastfeeding
• Drug Images
• Prosom Drug Interactions
• Prosom Support Group
• 1 Review for Prosom - Add your own review/rating

• Prosom Prescribing Information (FDA)


• Prosom MedFacts Consumer Leaflet (Wolters Kluwer)


• Prosom Concise Consumer Information (Cerner Multum)


• Estazolam Monograph (AHFS DI)


• Estazolam Prescribing Information (FDA)


• Estazolam Professional Patient Advice (Wolters Kluwer)

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