1 What is Prosom?

Brand: Prosom

Generic: Estazolam

Prosom is a benzodiazepine used for the short-term treatment (7-10 days) of insomnia, frequent nocturnal awakenings, and/or early morning awakenings.

This drug works as a hypnotic agent with anticonvulsant, hypnotic, and muscle relaxant properties that slow down the nervous system. This drug requires a prescription.

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2 What to Know Before Using

Before using Prosom, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children regarding the correlation of age to the effects of estazolam have not been performed while safety and efficacy have not been established.

Studies in the elderly have not reported any geriatric-specific problems that would limit the utility of estazolam. Adjustments in the dose of the elderly may be required since are more prone to severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness while taking this drug.

Fetal abnormalities have been associated with the use of this drug in pregnant women or animals. This drug is contraindicated in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Infant risk is still undetermined when taking this drug during breastfeeding.

Discuss with your healthcare professional about the risks and benefits of this drug before breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Flumazenil
  • Alfentanil
  • Amobarbital
  • Anileridine
  • Bromazepam
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlorzoxazone
  • Clarithromycin
  • Codeine
  • Dantrolene
  • Ethchlorvynol
  • Fentanyl
  • Flibanserin
  • Fospropofol
  • Hydrocodone
  • Hydromorphone
  • Levorphanol
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Oxycodone
  • Oxymorphone
  • Pentobarbital
  • Phenobarbital
  • Primidone
  • Propofol
  • Propoxyphene
  • Remifentanil
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Suvorexant
  • Tapentadol
  • Thiopental
  • Zolpidem
  • Theophylline

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as alcohol abuse, drug abuse or dependence, breathing problems or lung disease, depression, kidney or liver diseases.

3 Proper Usage

Proper usage of Prosom requires strict adherence to your doctor’s orders. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional. Take this drug before going to bed. The dose of this drug will be variable for different patients.

The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug. Adults with insomnia are initially given 1 milligram at bedtime. Older adults with insomnia are initially given 0.5 milligrams (mg) at bedtime. Use and dose in children must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Prosom, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened by blood tests.

This drug has teratogenic potential and it is recommended to practice birth control for the prevention of pregnancy. Inform your healthcare professional immediately if you think you have become pregnant while using this drug. Breastfeeding is not recommended while taking this drug.

Taking this drug with itraconazole (SporanoxВ®) or ketoconazole (NizoralВ®) may increase the chance of serious side effects. This drug may cause drowsiness, dizziness, or reduced alertness, especially in the elderly. Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous.

Discuss it with your healthcare professional if you develop any unusual or strange thoughts and behavior, confusion, worsening of depression, hallucinations, suicidal thoughts, and unusual excitement, nervousness, or irritability while taking this drug.

These symptoms have been strongly associated with excessive alcohol intake. Inform your healthcare professional immediately if experience any sleep-related behaviors such as driving a car, walking, having sex, making phone calls, or preparing and eating food while you are asleep or not fully awake.

This drug potentiates the effects of alcohol and other CNS depressants such as antihistamines or drug for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping drug, prescription pain drug or narcotics, barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This effect may last for a few days after you stop taking this drug. Consult with your healthcare professional before taking any of other prescription or non-prescription drugs and herbal or vitamin supplements.

Your healthcare professional may slowly taper the amount you are using before stopping it completely to help prevent worsening of your condition and reduce the possibility of withdrawal symptoms such as convulsions, hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

Smoking is not recommended while taking this drug. Seek medical attention immediately if your condition does not improve or if it becomes worse within 7 to 10 days.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Prosom. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • the absence of or decrease in body movement
  • clumsiness or unsteadiness
  • dizziness
  • sleepiness or unusual drowsiness
  • delusions
  • dementia
  • dry mouth
  • headache
  • mood or mental changes
  • nausea and vomiting
  • tiredness
  • 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
  • the 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
  • the false or unusual sense of well-being
  • fast, irregular, pounding or racing heartbeat or pulse
  • fear or nervousness
  • the feeling of warmth
  • fever
  • frequent strong or increased urge to urinate
  • hoarseness
  • increased the 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, blistering, peeling or loosening of the skin
  • diarrhea
  • fever with or without chills
  • the 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. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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