What is the most important information I should know about Zolpidem Tartrate Capsules?

Zolpidem Tartrate Capsules may cause serious side effects, including:

• Complex sleep behaviors. After taking Zolpidem Tartrate Capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. These activities may happen with Zolpidem Tartrate Capsules whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death. People taking zolpidem tartrate have reported:
  • sleep-walking
  • sleep-driving
  • making and eating food
  • talking on the phone
  • having sex

Stop taking Zolpidem Tartrate Capsules and tell your healthcare provider right away if you find out that you have done any of the above activities after taking Zolpidem Tartrate Capsules.

What are Zolpidem Tartrate Capsules?

Zolpidem Tartrate Capsules are a prescription sleep medicine used for the short-term treatment of adults younger than 65 years of age who have trouble falling asleep for a short period of time only (transient insomnia).
It is not known if Zolpidem Tartrate Capsules are safe and effective in children. Zolpidem Tartrate Capsules are not recommended for use in children or in adults over age 65.
Zolpidem Tartrate Capsules are a federally controlled substance (CIV) because they can be abused or lead to dependence. Keep Zolpidem Tartrate Capsules in a safe place to protect them from misuse and abuse and theft. Never give your Zolpidem Tartrate Capsules to anyone else because it may cause death or harm them. Selling or giving away Zolpidem Tartrate Capsules is against the law.

Do not take Zolpidem Tartrate Capsules if you:

• have had complex sleep behaviors that happened after taking zolpidem in the past. See “What is the most important information I should know about Zolpidem Tartrate Capsules?”
• are allergic to zolpidem or any of the ingredients in Zolpidem Tartrate Capsules. See the end of this Medication Guide for a complete list of ingredients in Zolpidem Tartrate Capsules.

Before taking Zolpidem Tartrate Capsules, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts or actions
• have a history of drug or alcohol abuse or addiction
• have kidney problems
• have liver problems. Zolpidem Tartrate Capsules should not be used in people with liver problems.
• have a lung disease or breathing problems
• have sleep apnea
• have myasthenia gravis
• are a female and are not currently taking another zolpidem tartrate medicine. If you have never taken a zolpidem tartrate medicine before, your healthcare provider should prescribe another product to start zolpidem tartrate.
• are pregnant or plan to become pregnant. Taking Zolpidem Tartrate Capsules in the third trimester of pregnancy may harm your unborn baby.
  • Tell your healthcare provider if you become pregnant or plan to become pregnant during treatment with Zolpidem Tartrate Capsules.
  • There is a pregnancy exposure registry for females who are exposed to psychiatric medicines during pregnancy. If you become pregnant during treatment with Zolpidem Tartrate Capsules, talk to your healthcare provider about registering you with the National Pregnancy Registry for Psychiatric Medications by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry.
  • Taking Zolpidem Tartrate Capsules during your third trimester of pregnancy may cause your baby to have breathing problems and sedation (such as unusual sleepiness or limp muscles).
• are breastfeeding or plan to breastfeed. Zolpidem tartrate passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Zolpidem Tartrate Capsules.
  • If you breastfeed during treatment with Zolpidem Tartrate Capsules:
    • call your healthcare provider or go to the nearest emergency room right away if your baby develops increased sleepiness, breathing problems, or limpness.
    • to decrease the chance of your baby getting the medicine through your breast milk, you can pump and throw away your breast milk during treatment with Zolpidem Tartrate Capsules and for 23 hours after stopping use of Zolpidem Tartrate Capsules.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Zolpidem Tartrate Capsules and other medicines can interact with each other causing serious side effects. Zolpidem Tartrate Capsules may affect the way other medicines work, and other medicines may affect how Zolpidem Tartrate Capsules works.

Especially tell your healthcare provider if you:

• take benzodiazepines
• take opioids as it may increase the risk of breathing problems (respiratory depression)
• take tricyclic antidepressants
• take other medicines that can make you sleepy or affect your breathing (including other zolpidem medicines)
• drink alcohol

If you take certain medicines, you may need to take another zolpidem tartrate medicine instead of Zolpidem Tartrate Capsules because the medicines may interact.
You can ask your pharmacist for a list of medicines that interact with Zolpidem Tartrate Capsules.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Zolpidem Tartrate Capsules?

• Take Zolpidem Tartrate Capsules exactly as your healthcare provider tells you to take them. Do not change your dose on your own. Tell your healthcare provider if you think Zolpidem Tartrate Capsules are not working for you.
• If your sleep problems do not get better within 7 to 10 days, or if they get worse, this may mean that there is another condition causing your sleep problems.
• Zolpidem Tartrate Capsules are for short-term use only. Treatment with Zolpidem Tartrate Capsules should be as short as possible because the risk of abuse and dependence increases the longer you are being treated.
• Take 1 Zolpidem Tartrate Capsule at night right before bedtime.
• Do not take Zolpidem Tartrate Capsules if you are not able to stay in bed a full night (7 to 8 hours) before you must be active again.
• Do not take more than 1 Zolpidem Tartrate Capsule during the same night.
• Do not take Zolpidem Tartrate Capsules with food or right after a meal.
• Do not take Zolpidem Tartrate Capsules if you drank alcohol that evening or before bed.
• Swallow Zolpidem Tartrate Capsules whole. Do not open, crush, or chew the capsules.

What are the possible side effects of Zolpidem Tartrate Capsules?

Zolpidem Tartrate Capsules may cause serious side effects, including:

• See "What is the most important information I should know about Zolpidem Tartrate Capsules?"
• Zolpidem Tartrate Capsules can make you sleepy or dizzy, can cause blurred or double vision, and can slow your thinking and motor skills. Because Zolpidem Tartrate Capsules can make you sleepy or dizzy you are at a higher risk for falls. You may still feel this way when you wake up in the morning.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Zolpidem Tartrate Capsules affects you.
  • Do not drink alcohol or take opioids or other medicines that may make you sleepy or dizzy while taking Zolpidem Tartrate Capsules without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, Zolpidem Tartrate Capsules may make your sleepiness or dizziness much worse.
• Severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Swelling of the tongue or throat may block your ability to breathe and can lead to death. Get emergency medical help right away if you develop any of these symptoms during treatment with Zolpidem Tartrate Capsules.
• Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion (delirium), acting or feeling strangely, agitation, and seeing or hearing things that aren’t real (hallucinations).
• Risk of suicide and worsening of depression. Worsening of depression and suicidal thoughts and actions, including completed suicides, can happen during treatment with medicines like Zolpidem Tartrate Capsules. Call your healthcare provider right away if you develop any thoughts of suicide, dying, or worsening depression during treatment with Zolpidem Tartrate Capsules.
• Breathing problems. Call your healthcare provider or get emergency medical help right away if you develop breathing problems during treatment with Zolpidem Tartrate Capsules. Certain medical conditions and medicines may increase your risk for breathing problems. See “Before taking Zolpidem Tartrate Capsules, tell your healthcare provider about all of your medical conditions, including if you:”
• Problems with your nervous system caused by severe liver disease (hepatic encephalopathy).
• Withdrawal symptoms. You may have withdrawal symptoms if you stop taking Zolpidem Tartrate Capsules suddenly. Withdrawal symptoms can be serious and include stomach and muscle cramps, vomiting, sweating, shakiness, seizures, and confusion (delirium). Talk to your healthcare provider about slowly stopping Zolpidem Tartrate Capsules to avoid withdrawal symptoms.

The most common side effects of Zolpidem Tartrate Capsules include headache, sleepiness, dizziness, and diarrhea.

These are not all the side effects of Zolpidem Tartrate Capsules.

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 Capsules?

• Store Zolpidem Tartrate Capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Zolpidem Tartrate Capsules come in a child resistant container.

Keep Zolpidem Tartrate Capsules and all medicines out of the reach of children.

General Information about the safe and effective use of Zolpidem Tartrate Capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Zolpidem Tartrate Capsules for a condition for which it was not prescribed. Do not give Zolpidem Tartrate Capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Zolpidem Tartrate Capsules that is written for health professionals.