Read the Medication Guide that comes with zolpidem tartrate before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.
You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with zolpidem tartrate. Reported activities include:
Zolpidem tartrate is a sedative-hypnotic (sleep) medicine. Zolpidem tartrate is used in adults for the short-term treatment of a sleep problem called insomnia. Symptoms of insomnia include:
Zolpidem tartrate is not for children.
Zolpidem tartrate is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate in a safe place to prevent misuse and abuse. Selling or giving away zolpidem tartrate may harm others, and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs.
Who should not take zolpidem tartrate?
Do not take zolpidem tartrate tablets if you are allergic to anything in it.
See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate tablets.
Zolpidem tartrate may not be right for you. Before starting zolpidem tartrate, tell your doctor about all of your health conditions, including if you:
- have a history of depression, mental illness, or suicidal thoughts
- have a history of drug or alcohol abuse or addiction
- have kidney or liver disease
- have a lung disease or breathing problems
- are pregnant, planning to become pregnant, or breastfeeding
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take zolpidem tartrate with other medicines that can make you sleepy.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take zolpidem tartrate?
- Take zolpidem tartrate exactly as prescribed. Do not take more zolpidem tartrate than prescribed for you.
Take zolpidem tartrate right before you get into bed.
Do not take zolpidem tartrate unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
- For faster sleep onset, zolpidem tartrate should NOT be taken with or immediately after a meal.
- Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
- If you take too much zolpidem tartrate or overdose, call your doctor or poison control center right away, or get emergency treatment.
What are the possible side effects of zolpidem tartrate?
Serious side effects of zolpidem tartrate include:
getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about zolpidem tartrate?”)
abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking zolpidem tartrate.
Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using zolpidem tartrate.
The most common side effects of zolpidem tartrate are:
- “drugged feelings”
- You may still feel drowsy the next day after taking zolpidem tartrate. Do not drive or do other dangerous activities after taking zolpidem tartrate until you feel fully awake.
After you stop taking a sleep medicine,
you may have symptoms for 1 to 2 days such as: trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain.
These are not all the side effects of zolpidem tartrate. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
How should I store zolpidem tartrate?
- Store zolpidem tartrate at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Keep zolpidem tartrate and all medicines out of reach of children.
General Information about zolpidem tartrate
- Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
- Do not use zolpidem tartrate for a condition for which it was not prescribed.
- Do not share zolpidem tartrate with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about zolpidem tartrate. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zolpidem tartrate that is written for healthcare professionals. For more information about zolpidem tartrate, call 1-866-850-2876.
What are the ingredients in zolpidem tartrate tablets?
lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Aurobindo Pharma Limited
Mahaboob Nagar (Dt)