Intermezzo (zolpidem) is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).
Intermezzo sublingual tablets are used to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.
Intermezzo may also be used for purposes not listed in this medication guide.
Important information
Do not share Intermezzo with another person, even if they have the same symptoms you have. The recommended doses of Intermezzo 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.
In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for zolpidem. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before.
Intermezzo may impair your thinking or reactions. You may still feel sleepy the morning after taking Intermezzo, especially 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.
Some people using this medicine 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 Intermezzo and talk with your doctor about another treatment for your sleep disorder.
Do not take this medicine if you have consumed alcohol during the day or just before bed.
Intermezzo may be habit forming. Keep the medication in a place where others cannot get to it.
Intermezzo may cause a severe allergic reaction. Stop taking this medicine 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.
Before taking this medicine
Some people using Intermezzo 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 this medicine and talk with your doctor about another treatment for your sleep disorder.
You should not use this medication if you are allergic to zolpidem.
To make sure Intermezzo is safe for you, tell your doctor if you have:
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kidney disease;
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liver disease;
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lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
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sleep apnea (breathing stops during sleep);
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myasthenia gravis;
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a history of depression, mental illness, or suicidal thoughts; or
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a history of drug or alcohol addiction.
Intermezzo may be habit forming and should be used only by the person it was prescribed for. Never share Intermezzo with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
Zolpidem can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
The sedative effects of zolpidem may be stronger in older adults.
Do not give this medicine to anyone younger than 18 years of age.
It is dangerous to try and purchase Intermezzo on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.
How should I take Intermezzo?
Take Intermezzo exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed.
Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of Intermezzo 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.
In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for zolpidem. If you have taken zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before.
Intermezzo comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.
Intermezzo 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. Do not take Intermezzo for longer than 4 or 5 weeks without your doctor"s advice.
Do not stop using Intermezzo suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.
Insomnia symptoms may also return after you stop taking Intermezzo. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
Do not swallow an Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Since Intermezzo is taken only at bedtime, you will not be on a frequent dosing schedule.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Intermezzo can be fatal 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 should I avoid?
Intermezzo may impair your thinking or reactions. You may still feel sleepy the morning after taking Intermezzo, especially if you are a woman. 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.
Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.
Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off.
Do not take this medicine if you have consumed alcohol during the day or just before bed.
Intermezzo side effects
Intermezzo may cause a severe allergic reaction. Stop taking Intermezzo 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.
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 Intermezzo and call your doctor at once if you have:
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chest pain, fast or irregular heartbeat, feeling short of breath;
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trouble breathing or swallowing; or
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feeling like you might pass out.
Common Intermezzo side effects may include:
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daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
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tired feeling, loss of coordination;
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stuffy nose, dry mouth, nose or throat irritation;
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nausea, constipation, diarrhea, upset stomach; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Intermezzo?
You may need a lower dose of Intermezzo if you take other medicines that make you sleepy or slow your breathing (such as cold medicine, pain medication, muscle relaxants, and medicine for depression, anxiety, or seizures). Tell your doctor if you are currently taking any of these medications.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Intermezzo, especially:
This list is not complete. Other drugs may interact with Intermezzo, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
