Intermezzo is a prescription medication used in adults for the treatment of insomnia. Intermezzo helps those patients that have difficulty returning to sleep after awakening in the middle of the night. Intermezzo belongs to a group of drugs called hypnotics. It works by slowing down brain activity so you can fall asleep.
Intermezzo comes as a sublingual tablet and is taken by mouth at night, if needed, without food. While in bed, place the tablet under your tongue and allow it to break apart completely. Do not swallow it whole.
Intermezzo is taken only if you have at least 4 hours of bedtime left.
Common side effects of Intermezzo include headache, nausea, and fatigue.
Intermezzo can cause daytime drowsiness and dizziness, and diarrhea. Do not drive or operate heavy machinery until you know how Intermezzo affects you.
Intermezzo is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Intermezzo in a safe place to prevent misuse and abuse. Selling or giving away Intermezzo may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Intermezzo is a prescription medication used to treat insomnia. It is specifically designed to treat patients that wake in the night and have difficulty returning to sleep.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Intermezzo may cause serious side effects, including:
- getting out of bed while not being fully awake and doing an activity that you do not know you are doing.
- abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
- memory loss
- anxiety
- severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking Intermezzo.
Call your health care provider right away if you have any of the above side effects or any other side effects that worry you while using Intermezzo.
The most common side effects of Intermezzo are:
- Headache
- Nausea
- Fatigue
Even if you follow the Instructions for Use, you may still feel drowsy in the morning after taking Intermezzo. Do not drive or do other dangerous activities after taking Intermezzo until you are fully awake.
These are not all the side effects of Intermezzo. Ask your health care provider or pharmacist for more information.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- antidepressants including imipramine (Tofranil) and sertraline (Zoloft)
- chlorpromazine (Thorazine);
- itraconazole (Sporanox);
- ketoconazole (Nizoral);
- medications for anxiety, colds or allergies, mental illness, pain, or seizures;
- rifampin (Rifadin, Rimactane);
- sedatives;
- sleeping pills;
- tranquilizers.
This is not a complete list of Intermezzo drug interactions. Ask your doctor or pharmacist for more information.
Intermezzo is a federally controlled substance (CIV) because it can be abused or lead to dependence. Keep Intermezzo in a safe place to prevent misuse and abuse. Selling or giving away Intermezzo may harm others, and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines, or street drugs.
- Only take one tablet a night, if needed.
- Only take Intermezzo if you have at least 4 hours of bedtime left.
Intermezzo may cause serious side effects, including:
- After taking Intermezzo, 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. You have a higher chance for doing these activities if you drank alcohol that day or take other medicines that make you sleepy with Intermezzo. Reported activities include:
- driving a car ("sleep-driving")
- making and eating food
- talking on the phone
- having sex
- sleep-walking
Call your healthcare provider right away if you find out that you have done any of the above activities after taking Intermezzo.
Important:
- Take Intermezzo exactly as prescribed
- Do not take Intermezzo if you:
- drank alcohol that day or before bed.
- took another medicine to help you sleep.
- do not have at least 4 hours of bedtime remaining.
Do not take Intermezzo if you are allergic to zolpidem or any other ingredients in Intermezzo. See the end of this Medication Guide for a complete list of ingredients in Intermezzo.
Do not take Intermezzo if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Edluar, or Zolpimist.
Symptoms of a serious allergic reaction to Intermezzo can include:
- swelling of your face, lips, and throat that may cause difficulty breathing or swallowing
- nausea and vomiting
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Intermezzo there are no specific foods that you must exclude from your diet when receiving Intermezzo.
Before starting Intermezzo, tell your doctor about all of your health conditions, including if you:
- have a history of depression, mental illness, or suicidal thoughts
- have a history of drug or alcohol abuse or addiction
- have kidney or liver disease
- have a lung disease or breathing problems
- are pregnant, planning to become pregnant, or breastfeeding
Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Your doctor will tell you if you can take Intermezzo with your other medicines.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Intermezzo will harm your unborn baby.
Tell your doctor if you are breastfeeding or plan to breastfeed. Intermezzo is excreted in human breast milk. The effect of Intermezzo on the nursing infant is not known.
- Take Intermezzo exactly as prescribed. Only take one Intermezzo tablet per night if needed.
- Do not take Intermezzo if you drank alcohol that evening or before bed.
- While in bed, place the tablet under your tongue and allow it to break apart completely. Do not swallow it whole.
- You should not take Intermezzo with or right after a meal. Intermezzo may help you fall asleep faster when you take it on an empty stomach.
- Call your health care provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
- If you take too much Intermezzo or overdose get emergency treatment.
The recommended and maximum dose of Intermezzo is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. The recommended doses for women and men are different because women clear this medication from the body at a lower rate than men.
Use with CNS Depressants
The recommended Intermezzo dose for men and women who are taking concomitant CNS depressants is 1.75 mg. Dose adjustment of concomitant CNS depressants may be necessary when co-administered with Intermezzo because of potentially additive effects. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.
Use in Geriatric Patients
Geriatric patients may be especially sensitive to the effects of zolpidem. The recommended dose of Intermezzo in men and women over 65 years old is 1.75 mg, taken only once per night if needed.
Use in Patients with Hepatic Impairment
The recommended dose of Intermezzo in patients with hepatic impairment is 1.75 mg, taken only once per night if needed.
If you take too much Intermezzo call your local Poison Control Center or seek emergency medical attention right away.
Intermezzo sublingual tablets are available in 1.75 mg and 3.5 mg strengths.
Active Ingredient: Zolpidem tartrate
Inactive Ingredients: Each Intermezzo tablet includes the following inactive ingredients: mannitol, sorbitol, crospovidone, silicon dioxide, sodium carbonate, sodium bicarbonate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide, natural and artificial spearmint flavor, silicon dioxide-colloidal, and sucralose. The 1.75 mg tablet also contains yellow iron oxide, and the 3.5 mg tablet contains beige iron oxide.
- Store Intermezzo at room temperature, 68° to 77°F (20° to 25°C). Protect from moisture.
- Only open the pouch when you are ready to use Intermezzo.
Keep Intermezzo and all medicines out of reach of children.