Zolpidem (Generic Ambien) – USA Domestic

Description

What is zolpidem?

Zolpidem is used in adults to treat insomnia.

The immediate-release forms are Ambien, Edluar, and Zolpimist, which are used to help you fall asleep. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping. The extended-release form of zolpidem is Ambien CR which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Your doctor will determine which form of zolpidem is best for you.

Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.

Zolpidem side effects

Get emergency medical help if you have signs of an allergic reaction to zolpidem: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using zolpidem have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens, stop using zolpidem and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

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

• breathing problems;
• anxiety, depression, agitation, aggression;
• confusion, hallucinations;
• memory problems, unusual thoughts or behavior;
• thoughts of hurting yourself; or
• a light-headed feeling, like you might pass out.

Common zolpidem side effects may include:

• daytime drowsiness, dizziness, feeling light-headed or “drugged”;
• headache;
• diarrhea; or
• feeling tired.

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.

Warnings

Never use zolpidem in larger amounts, or for longer than prescribed.

Some people using zolpidem 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.

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert. Serious injury or death could occur if you walk or drive while you are not fully awake.

Never take this medicine in larger amounts or for longer than prescribed.

Do not take zolpidem if you have consumed alcohol during the day or just before bed.

Before taking this medicine

You should not use zolpidem if you are allergic to it, or if you have ever taken sleep medicine and engaged in activity you later don’t remember.

Zolpidem may contain lactose. Tell your doctor if you have galactose intolerance, or severe problems with lactose (milk sugar).

To make sure zolpidem is safe for you, tell your doctor if you have ever had:

• lung disease or a breathing disorder;
• depression, suicidal thoughts or actions, or mental illness;
• drug or alcohol addiction;
• sleep apnea (breathing stops during sleep);
• myasthenia gravis; or
• liver or kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant. Using this medicine during the last 3 months of pregnancy may harm the unborn baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of zolpidem on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

If you are breastfeeding, tell your doctor if you notice increased sleepiness, breathing problems, or limpness in the nursing baby.

Do not breastfeed within 23 hours after using zolpidem. If you use a breast pump during this time, throw out the milk and do not feed it to your baby.

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

How should I use zolpidem?

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

Zolpidem may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Zolpidem should be taken right before going to sleep on an empty stomach. Allow the orally disintegrating tablet to dissolve in your mouth without chewing, swallowing or drinking water.

Do not use orally disintegrating tablet for insomnia if you wake up in the middle of the night unless you have 4 hours of sleep time left before being active.

Zolpidem will make you fall asleep. Never use this medicine if you do not have a full 7 to 8 hours to sleep before being active again.

Swallow the tablet or the capsule whole and do not crush, chew, or break.

Zolpidem is only for short-term use. Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse.

You may have withdrawal symptoms if you stop using zolpidem suddenly. Ask your doctor before stopping the medicine.

Keep zolpidem in the original container until you are ready to use it.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Adult Dose for Insomnia:

IMMEDIATE RELEASE (IR) TABLETS, ORAL SPRAY, and SUBLINGUAL TABLETS (5 and 10 mg formulations):
Initial dose:
-Women: 5 mg orally once a day immediately prior to bedtime
-Men: 5 to 10 mg orally once a day immediately prior to bedtime
Maintenance dose: 5 to 10 mg orally once a day immediately prior to bedtime
Maximum dose: 10 mg/day

CONTROLLED/EXTENDED RELEASE (CR/ER) TABLETS:
Initial dose:
-Women: 6.25 mg orally once a day immediately prior to bedtime
-Men: 6.25 to 12.5 mg orally once a day immediately prior to bedtime
Maintenance dose: 6.25 to 12.5 mg orally once a day immediately prior to bedtime
Maximum dose: 12.5 mg/day

SUBLINGUAL TABLETS (1.75 and 3.5 mg Formulations):
Women: 1.75 mg orally once a day at night as needed
-Maximum dose: 1.75 mg/day

Men: 3.5 mg orally once a day at night as needed
-Maximum dose: 3.5 mg/day

Comments:
-The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.
-Clinical trials supporting IR tablet efficacy were 4 to 5 weeks’ duration, while CR/ER tablet efficacy were 3 to 24 weeks in duration.
-The 1.75 and 3.5 mg sublingual tablet formulations should be taken when the patient wakes in the middle of the night and has trouble falling back to sleep.
-LIMITATION OF USE: The 1.75 and 3.5 mg sublingual tablet formulations are not indicated for the treatment of insomnia in patients who have less than 4 hours of bedtime remaining before the planned awakening time.

Uses:
-IR Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Short-term treatment of insomnia characterized by difficulties with sleep initiation
-CR/ER Tablets: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset)
-Sublingual Tablets (1.75 and 3.5 mg Formulations): As needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep

Usual Geriatric Dose for Insomnia:

IR TABLETS, ORAL SPRAY, and SUBLINGUAL TABLETS (5 and 10 mg formulations): 5 mg orally once a day immediately prior to bedtime
-Maximum dose: 5 mg/day

CR/ER TABLETS:
Patients 65 years and over: 6.25 mg orally once a day at night immediately prior to bedtime
-Maximum dose: 6.25 mg/day

SUBLINGUAL TABLETS (1.75 and 3.5 mg Formulations):
Patients over 65 years: 1.75 mg orally once a day at night as needed
-Maximum dose: 1.75 mg/day

Comments:
-Doses are the same in men and women.
-Clinical trials supporting IR tablet efficacy were 4 to 5 weeks’ duration, while CR/ER tablet efficacy were 3 to 24 weeks in duration.
-The 1.75 sublingual tablet formulations should be taken when the patient wakes in the middle of the night and has trouble falling back to sleep.
-LIMITATION OF USE: The 1.75 sublingual tablet formulations are not indicated for the treatment of insomnia in patients who have less than 4 hours of bedtime remaining before the planned awakening time.

Uses:
-IR Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Short-term treatment of insomnia characterized by difficulties with sleep initiation
-CR/ER Tablets: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset)
-Sublingual Tablets (1.75 and 3.5 mg Formulations): As needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep

What happens if I miss a dose?

Zolpidem is used only at bedtime if needed. If you are on a dosing schedule, do not use zolpidem if you do not have 7 to 8 hours to sleep before being active again.

Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal. Overdose symptoms include severe drowsiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What should I avoid while using zolpidem?

Avoid using zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.

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

Avoid using zolpidem with food or right after eating a meal, it may take longer for your body to absorb the medicine.

Avoid driving or hazardous activity until you know how zolpidem will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What other drugs will affect zolpidem?

Using zolpidem with other drugs that make you drowsy 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.

Tell your doctor about all your other medicines, especially:

• St. John’s wort;
• sertraline, fluoxetine; or
• rifampin, ketoconazole.

This list is not complete. Other drugs may affect zolpidem, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.