May 22, 2017
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Intermezzo

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Intermezzo




Intermezzo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 02/22/2017

Intermezzo (zolpidem tartrate) sublingual is a non-benzodiazepine hypnotic indicated as an as-needed to treatment for a type of insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. Intermezzo is available as a generic termed zolpidem. Common side effects of Intermezzo include:

Tell your doctor if you have serious side effects of Intermezzo including:

  • chest pain,
  • fast or irregular heartbeat,
  • shortness of breath,
  • trouble breathing or swallowing, or
  • feeling like you might pass out.

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.

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. Intermezzo may interact with alcohol, other medicines that make you sleepy or slow your breathing (such as cold medicines, pain medications, muscle relaxants, and medicines for anxiety or seizures), chlorpromazine, itraconazole, ketoconazole, rifampin, or antidepressants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Intermezzo; it is unknown if Intermezzo will harm a fetus. Intermezzo can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

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 3way 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%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Intermezzo. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.

  • Application site reactions, primarily in the sublingual area, have been reported. These application site reactions included oral ulcers, blisters, and mucosal inflammation.

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

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.


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