Generic name: zolpidem (zole PI dem)
Brand name: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics
Zolpidem is a sedative, also called a hypnotic. It affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).
Zolpidem is used to treat insomnia. The immediate-release forms are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. 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.
Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. 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.
Your doctor will determine which form of zolpidem is best for you.
Warnings
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.
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
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 to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.
You should not use this medicine if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.
Zolpidem is not approved for use by anyone younger than 18 years old.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
- depression, mental illness, or suicidal thoughts;
- drug or alcohol addiction;
- lung disease or breathing problems;
- sleep apnea (breathing stops during sleep); or
- liver or kidney disease.
Taking zolpidem in the last 3 months of pregnancy may cause drowsiness or breathing problems in your newborn.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
How should I take zolpidem?
The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.
Take zolpidem exactly as prescribed by your doctor, Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more or increase your dose.
Zolpidem may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.
Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.
Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row.
Store at room temperature away from moisture and heat. Do not freeze. Keep the medication in a place where others cannot get to it. Keep the Zolpimist bottle upright when not in use.
Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Insomnia symptoms may also return after you stop taking zolpidem, and may be even worse than before. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
What happens if I miss a dose?
Since zolpidem is taken only at bedtime if needed, you are not likely to miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.
Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
What to avoid
Avoid taking 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 this medicine.
Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy in the morning, and your reactions could be impaired. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Do not take this medicine if you have consumed alcohol during the day or just before bed.
Zolpidem side effects
Zolpidem may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to zolpidem: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.
Stop using this medicine and call your doctor at once if you have:
- chest pain, fast or irregular heartbeat, feeling short of breath;
- trouble breathing or swallowing; or
- feeling like you might pass out.
The sedative effect of zolpidem may be stronger in older adults.
Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.
Common zolpidem side effects may include:
- daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
- tired feeling, loss of coordination;
- stuffy nose, dry mouth, nose or throat irritation;
- nausea, constipation, diarrhea, upset stomach; or
- headache, muscle pain.
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.
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 other drugs will affect zolpidem?
Using zolpidem with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.