Prosom (Oral)

Estazolam is used to treat insomnia (difficulty sleeping). This medicine is meant for short-term use only, typically 7 to 10 days. Estazolam is a benzodiazepine. Benzodiazepines are a type of medicine known as central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

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

It is very important that your doctor checks 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 avoid 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 take more than your prescribed dose. Call your doctor for instructions.

This medicine may cause some people, especially older adults, to become drowsy, dizzy, or less alert than they usually are. 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 similar to those seen in people who drink too much alcohol. Other changes might include 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 and may cause 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.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a decision you should make with your doctor. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies done to see how estazolam affects children. Safety and effectiveness have not been established for this age group.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the usefulness of estazolam. However, older adults are more likely to experience severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness, which may require a change in dose for those taking estazolam.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together with caution. If you are prescribed this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted for 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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 increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Rifapentine
• St John's Wort
• Theophylline

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food since interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been highlighted for their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Alcohol or drug abuse or dependence, or history of, or
• Severe breathing problems or lung disease, or
• History of depression—Use with caution. This may make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

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

Check with your doctor right away if any of the following side effects happen:

More common

• No movement or less body movement
• Clumsiness or unsteadiness
• Dizziness
• Sleepiness or unusual drowsiness

Less common

• Dry mouth
• False beliefs that cannot be changed by facts
• Headache
• Changes in mood or mental state
• Nausea and vomiting
• Poor insight and judgment
• Memory or speech problems
• Tiredness
• Trouble thinking and planning
• Trouble walking

Rare

• Aggression or anger
• 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 urine amount
• 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 at night
• Irritability
• Lack of feeling or emotion
• Loss of bladder control
• Loss of memory
• Mouth sores or ulcers
• Muscle spasms or jerking of all limbs
• Noisy breathing
• Numbness of the feet, hands, and around the mouth
• Paranoia
• Memory problems
• Quick to react or overreact emotionally
• Rapidly changing moods
• Redness of the face, neck, arms, and sometimes the upper chest
• Restlessness
• Seeing, hearing, or feeling things that are not there
• Seizures
• Feeling detached from oneself or body
• Severe sleepiness
• Severe stomach pain
• Shakiness and unsteady walking
• 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 swallowing
• Trouble sleeping
• Not caring
• Uncontrolled eye movements
• Unsteadiness, trembling, or other muscle control or coordination problems
• 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 overdose symptoms 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. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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

• Skin blemishes
• Feeling bloated
• Blurred vision
• Burning feeling in the chest or stomach
• Change in color vision
• Unpleasant or unusual aftertaste
• Changes in vision, especially night blindness
• Continuing ringing, buzzing, or other unexplained noises in the ears
• Cramping in the lower stomach, back, or legs
• Decreased interest in sexual activity
• Difficulty having a bowel movement (stool)
• Difficulty moving
• Difficulty seeing at night
• Double vision
• Ear or eye pain
• Excess air or gas in the stomach or intestines
• Feeling full
• Glare or snowy images 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 of 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 the 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.

In the U.S.

• Prosom

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypnotic

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

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.