FDA Approves Intermezzo

The U.S. Food and Drug Administration has approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

This is the first time the FDA has approved a drug for this condition. 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.

The active ingredient in Intermezzo, zolpidem tartrate, was first approved in the United States in 1992 under the brand name Ambien. Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.

Intermezzo Medication Guide

Read the Medication Guide that comes with Intermezzo before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

Important information about Intermezzo

Follow the Instructions for Use at the end of this Medication Guide when you take Intermezzo. If you do not follow the Instructions for Use, you might be drowsy in the morning without knowing it.

* 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:

o driving a car ("sleep-driving")

o talking on the phone

o having sex

o sleep-walking

o making and eating food

Call your healthcare provider right away if you find out that you have done any of the above activities after taking Intermezzo.

Important:

1. Take Intermezzo exactly as prescribed

2. 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.

What is Intermezzo?

Intermezzo is a sedative-hypnotic (sleep) medicine. Intermezzo is used in adults for the treatment of a sleep problem called insomnia. Many people have difficulty returning to sleep after awakening in the middle of the night. Intermezzo is designed to specifically treat this problem.

It is not known if Intermezzo is safe and effective in children.

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 have been dependent on alcohol, prescription medicines, or street drugs.

Who should not take Intermezzo?

* 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

Intermezzo may not be right for you. 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.

Intermezzo may cause serious side effects, including:

* getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See Important information about Intermezzo)

* 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.

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.

General Information about Intermezzo

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Intermezzo for a condition for which it was not prescribed. Do not give Intermezzo to other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.

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.

Instructions for Use

Follow these Instructions for Use when you take Intermezzo. If you do not follow these instructions, you might be drowsy in the morning without knowing it.

* Only take one tablet a night if needed

* Only take Intermezzo if you have at least 4 hours of bedtime left

Using Intermezzo the wrong way can make you drowsy in the morning.

Before you go to bed:

* Place only ONE Intermezzo pouch by your bed, and have a clock or watch nearby.

* Store all other unopened Intermezzo pouches with your other medicines away from your bedside.

* Only open the Intermezzo pouch when you are ready to use it.

* You can either use the Intermezzo Dosing Time Chart or the Dosing Time Tool that comes with Intermezzo to find the latest time during the night you can take Intermezzo.

You can take Intermezzo if you have at least 4 hours of bedtime left before you must be awake.

* Find the earliest time you have to be up and awake in the column on the left.

* Find the latest time you can take Intermezzo on the same line in the column on the right.