Generic Name: estazolam (es-TA-zoe-lam)

Brand Names: Prosom®

Classification: Benzodiazepines

Issue Date: 1983

Estazolam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Estazolam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia). Estazolam is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Do not use this medication if you are allergic to estazolam or to other benzodiazepines, such as:

• alprazolam (Xanax®)
• chlordiazepoxide (Librium®)
• clorazepate (Tranxene®)
• diazepam (Valium®)
• lorazepam (Ativan®)
• temazepam (Restoril®)
• triazolam (Halcion®)

This medication can cause birth defects in an unborn baby, or withdrawal symptoms in a newborn. Do not use estazolam if you are pregnant.

Before taking estazolam, tell your doctor if you have a history of:

• depression
• suicidal thoughts
• addiction to drugs or alcohol

Take estazolam only when you are getting ready for several hours of sleep. Avoid using other medicines that make you sleepy. They can add to sleepiness caused by estazolam.

Do not drink alcohol while taking estazolam. It can increase some of the side effects, and could possibly cause a fatal overdose.

Estazolam may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take estazolam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Contact your doctor if this medicine seems to stop working as well in helping you fall asleep and stay asleep.

Estazolam should be used for only a short time to treat insomnia. After 7 to 10 nights of use, talk with your doctor about whether or not you should keep taking estazolam. Do not take this medication for longer than 12 weeks without your doctor's advice.

Your insomnia symptoms may return when you stop using estazolam after using it over a long period of time. You may need to use less and less before you stop the medication completely.

Estazolam may be habit-forming and should be used only by the person it was prescribed for. Estazolam should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Store estazolam at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Benzodiazepines are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Do not use this medication if you are allergic to estazolam or to other benzodiazepines, such as:

• alprazolam (Xanax®)
• chlordiazepoxide (Librium®)
• clorazepate (Tranxene®)
• diazepam (Valium®)
• lorazepam (Ativan®)
• temazepam (Restoril®),
• triazolam (Halcion®)

Before taking estazolam, tell your doctor if you are allergic to any drugs, or if you have:

• asthma, emphysema, bronchitis
• chronic obstructive pulmonary disorder (COPD), or other breathing problems
• tell your doctor if you smoke
• glaucoma
• kidney or liver disease
• myasthenia gravis
• history of depression or suicidal thoughts or behavior
• history of drug or alcohol addiction

If you have any of these conditions, you may not be able to use estazolam, or you may need a dosage adjustment or special tests during treatment.

Estazolam can cause birth defects in an unborn baby. It may also cause addiction or withdrawal symptoms in a newborn if the mother takes estazolam late in pregnancy. Do not use estazolam if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Estazolam may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of estazolam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking estazolam.

Do not give this medication to anyone under 18 years old.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of estazolam can be fatal.

Symptoms of a desipramine overdose include:

• extreme drowsiness
• feeling light-headed
• confusion
• muscle weakness
• slurred speech
• tremors
• slow heartbeat
• shallow breathing
• feeling light-headed
• fainting
• seizure (black-out or convulsions)
• coma

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

Call your doctor at once if you have any of these SERIOUS side effects:

• weak or shallow breathing
• fast or pounding heartbeats
• confusion, slurred speech, unusual thoughts or behavior
• hallucinations, agitation, aggression
• thoughts of suicide or hurting yourself
• restless muscle movements in your eyes, tongue, jaw, or neck
• pale skin, easy bruising or bleeding, unusual weakness
• fever, chills, body aches, flu symptoms
• problems with urination
• nausea, stomach pain, low fever, loss of appetite
• dark urine, clay-colored stools
• jaundice (yellowing of the skin or eyes)

Continue taking estazolam and talk with your doctor if you have any of these less serious side effects:

• daytime drowsiness (or during hours when you are not normally sleeping)
• amnesia or forgetfulness
• muscle weakness, lack of balance or coordination
• numbness, burning, pain, or tingly feeling
• headache, blurred vision, depressed mood
• feeling nervous, excited, or irritable
• nausea, vomiting, stomach discomfort
• dry mouth, increased thirst

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Before taking estazolam, tell your doctor if you are using any of the following drugs:

• cimetidine (Tagamet®)
• diltiazem (Cardizem®, Cartia®, Tiazac®)
• azithromycin (Zithromax®)
• clarithromycin (Biaxin®)
• erythromycin (E-Mycin®, Ery-Tab®)
• isoniazid
• itraconazole (Sporanox®)
• ketoconazole (Nizoral®)
• rifampin (Rifadin®, Rimactane®, Rifater®)
• fluvoxamine (Luvox®)
• nefazodone (Serzone®)
• amobarbital (Amytal®)
• butabarbital (Butisol®)
• mephobarbital (Mebaral®)
• secobarbital (Seconal®)
• phenobarbital (Luminal®, Solfoton®)
• isocarboxazid (Marplan®)
• phenelzine (Nardil®)
• rasagiline (Azilect®)
• selegiline (Eldepryl®, Emsam®)
• tranylcypromine (Parnate®)
• chlorpromazine (Thorazine®)
• haloperidol (Haldol®)
• mesoridazine (Serentil®)
• pimozide (Orap®)
• thioridazine (Mellaril®)
• carbamazepine (Carbatrol®, Tegretol®)
• phenytoin (Dilantin®)

If you are using any of these drugs, you may not be able to use estazolam, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estazolam. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.