Estazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to treat insomnia (trouble falling or staying asleep).

Estazolam may also be used for purposes not listed in this medication guide.

Estazolam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Do not stop using estazolam without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using estazolam and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Do not use if you are pregnant.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use estazolam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of estazolam.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

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

Call your doctor if your insomnia does not improve after taking estazolam for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions. Do not take estazolam for longer than 12 weeks without your doctor's advice.

Do not stop using estazolam without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

Your insomnia symptoms may return when you stop using estazolam after using it over a long period of time.

Usual Adult Dose for Insomnia:

1 to 2 mg orally at bedtime

Use: Short-term management of insomnia

Usual Geriatric Dose for Insomnia:

1 mg orally at bedtime

Comments:
-Dose increases should be initiated with care.
-In small or debilitated older patients, a starting dose of 0.5 mg should be considered.

Use: Short-term management of insomnia

You should not use estazolam if you are allergic to it, or:

• if you are pregnant; or

• if you are also using itraconazole or ketoconazole.

May cause birth defects. Do not use if you are pregnant. If you use estazolam during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks. Use effective birth control while using estazolam. Tell your doctor if you become pregnant.

Tell your doctor if you have ever had:

• breathing problems;

• drug or alcohol addiction;

• suicidal thoughts or actions;

• depression or mental illness; or

• liver or kidney disease.

Do not breastfeed.

Not approved for use by anyone younger than 18 years old.

Estazolam is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of estazolam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include drowsiness, confusion, slurred speech, weak or shallow breathing, or coma.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid taking estazolam with food or right after a meal.

You may still feel sleepy the morning after taking estazolam. Wait until you are fully awake before you drive, operate machinery, or do anything that requires you to be awake and alert. Your reactions may be impaired.

Estazolam may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.

Estazolam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Estazolam may cause serious side effects. Call your doctor at once if you have:

• unusual thoughts or behavior;

• depressed mood, thoughts about suicide or hurting yourself;

• confusion, hallucinations, aggression, agitation; or

• worsening sleep problems.

Some people using estazolam have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common side effects of estazolam may include:

• drowsiness, dizziness;

• headache;

• feeling tired;

• dry mouth; or

• upset stomach.

After you stop using estazolam, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping estazolam suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using estazolam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect estazolam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Estazolam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.