ZOLPIDEM- zolpidem tartrate tablet 
ACI Healthcare USA, Inc

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MEDICATION GUIDE

Zolpidem (zol' pi dem) Tartrate

Tablets, for oral use, C-IV

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

Zolpidem tartrate tablets may cause serious side effects, including:

        ○ sleep-walking

        ○ sleep-driving

        ○ making and eating food

        ○ talking on the phone

        ○ having sex

Stop taking Zolpidem tartrate tablets and call your healthcare provider right away if you find out that you have done any of the above activities after taking Zolpidem tartrate tablets.

What is Zolpidem Tartrate Tablet?

Zolpidem Tartrate Tablets is a prescription sleep medicine used for the short-term treatment of adults who have trouble falling asleep (insomnia).

Keep Zolpidem tartrate tablets in a safe place to protect it from theft. Never give your Zolpidem tartrate tablets to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.

Do not take Zolpidem tartrate tablets if you:

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

        ○ Tell your healthcare provider if you become pregnant or plan to become pregnant during treatment with Zolpidem tartrate tablets.

        ○ Babies born to mothers who take Zolpidem tartrate tablets during the third trimester of pregnancy may have symptoms of breathing problems and sedation (such as sleepiness or low muscle tone).

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Zolpidem tartrate tablets and other medicines can interact with each other causing serious side effects. Zolpidem tartrate tablets may affect the way other medicines work, and other medicines may affect how Zolpidem tartrate tablets works.

Especially tell your healthcare provider if you:

You can ask your pharmacist for a list of medicines that interact with Zolpidem tartrate tablets.

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 tablets?

What are the possible side effects of Zolpidem Tartrate Tablets?

Zolpidem Tartrate Tablets may cause serious side effects, including:

        ○ Do not drive, operate heavy machinery, or do other dangerous activities until you know how Zolpidem tartrate tablets affects you.

        ○ Do not drink alcohol or take opioids or other medicines that may make you sleepy or dizzy while taking Zolpidem tartrate tablets without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, Zolpidem Tartrate Tablets may make your sleepiness or dizziness much worse.

The most common side effects of Zolpidem tartrate tablets include sleepiness, dizziness, diarrhea, and grogginess or feeling like you have been drugged.

These are not all the side effects of Zolpidem tartrate tablets.

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 tablets?

Keep Zolpidem tartrate tablets and all medicines out of reach of children.

General Information about the safe and effective use of Zolpidem tartrate tablets

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

What are the ingredients in Zolpidem tartrate tablets?

Active Ingredient: Zolpidem tartrate

Inactive Ingredients: lactose anhydrous, sodium starch glycolate, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate. The 10 mg tablets also contain Opadry II (white) and the 5 mg tablets contain Opadry II (pink). Opadry II (white) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide, and triacetin. Opadry II (pink) contains hypromellose, FD&C Red no. 40 aluminum lake, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, polyethylene glycol, polydextrose, titanium dioxide, and triacetin.

Manufactured for:

The ACME Laboratories Ltd.

Dhulivita, Dhamrai,

Dhaka, 1350

Bangladesh

Distributed by:

ACI Healthcare USA, Inc.

10100 W. Sample Road,

Suite 406 Coral Springs, FL 33065

Revised: 6/2023

Revised: 11/2023
ACI Healthcare USA, Inc