Recommended Topic Related To:

Intermezzo

"June 13, 2012 -- A new sleeping pill under study helps insomniacs fall asleep faster and stay asleep longer, according to new research.

The medicine, called suvorexant, is not available -- it has not yet been submitted to the FDA. Suv"...

Intermezzo

Intermezzo Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Intermezzo (zolpidem tartrate) sublingual tablets are indicated as an as-needed to treatment for a type of insomnia that is characterized by middle-of-the-night waking followed by difficulty returning to sleep. Intermezzo is available as a generic termed zolpidem. The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.

Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien. Intermezzo is a lower dose formulation of zolpidem. Intermezzo is available as 1.75 and 3.5 mg strength tablets for sublingual administration. 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 may cause serious side effects, including getting out of bed while not fully awake and doing an activity that is not remembered. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking-without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that cause drowsiness. Intermezzo is a federally controlled substance because it can be abused or lead to dependence. Intermezzo may not be right for everyone. Before starting Intermezzo, women should tell their doctors about all of your health conditions, including if they are pregnant; planning to become pregnant, or are breastfeeding. Cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other substances that depress the central nervous systems. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. Intermezzo should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Intermezzo is not recommended for use in the pediatric population.

Our Intermezzo Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Intermezzo in Detail - Patient Information: Side Effects

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.

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 zolpidem 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.

Common 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.

Read the entire detailed patient monograph for Intermezzo (Zolpidem Tartrate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Intermezzo FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions in zolpidem-treated patients are discussed in greater detail in other sections of the labeling:

  • CNS-depressant effects and next-day impairment [see WARNINGS AND PRECAUTIONS]
  • Serious anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
  • Abnormal thinking and behavioral changes, and complex behaviors [see WARNINGS AND PRECAUTIONS]
  • Withdrawal effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

The safety data described below are based on two double-blind placebo-controlled trials of Intermezzo in adult patients with insomnia characterized by difficulty returning to sleep after a middle-of-the-night awakening [see Clinical Studies]. These two trials included 230 and 82 patients treated with 3.5 mg and 1.75 mg of Intermezzo, respectively. The first study was a 3-way crossover sleep-laboratory study in 82 patients (58 female and 24 male; median age 47 years; 51% Caucasian, 44% African-American) of 1.75 mg and 3.5 mg of Intermezzo compared to placebo (Study 1). The second study was a 4-week, parallel-group at-home study in 295 patients (201 female and 94 male; median age 43 years) of 3.5 mg of Intermezzo compared to placebo, used on an as-needed basis after spontaneous middle-of-the-night awakenings (Study 2). In Study 2, patients took Intermezzo during the night on 62% of study nights.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in actual practice.

Table 1 shows the incidence of adverse reactions reported in Study 2 that occurred in 2% or more of Intermezzo-treated (3.5 mg) patients in which the incidence was greater than the incidence in placebo-treated patients. For women and other patients taking the 1.75 mg dose in Study 1, the incidence of adverse reactions was similar to the incidence seen with 3.5 mg of Intermezzo in Table 1.

The most commonly reported adverse reactions in all treatment groups were headache, nausea, and fatigue.

Table 1: Summary of Adverse Reactions ( ≥ 2%) in Outpatient, Double-Blind, Parallel-Group, Placebo-Controlled Study (Study 2)

MedDRA System Organ Class Preferred Term 3.5 mg Intermezzo
(n=150)
Placebo
(n=145)
Gastrointestinal Disorders 4% 2%
  Nausea 1% 1%
General Disorders and Administration Site Conditions 3% 0%
  Fatigue 1% 0%
Nervous System Disorders 5% 3%
  Headache 3% 1%

Read the entire FDA prescribing information for Intermezzo (Zolpidem Tartrate) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.