Generic name: Estazolam
Pregnancy & Lactation: Risk data not available
What is Prosom?
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.
Warnings
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.
How should I use Prosom
Use Prosom (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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 this medicine.
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.
Estazolam is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.
Prosom side effects
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.
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 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 this medicine 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.
What other drugs will affect Prosom?
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 this medicine. 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.