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Intermezzo Side Effects

Generic Name: zolpidem

Note: This document contains side effect information about zolpidem. Some of the dosage forms listed on this page may not apply to the brand name Intermezzo.

For the Consumer

Applies to zolpidem: spray, tablet

Other dosage forms:

Along with its needed effects, zolpidem (the active ingredient contained in Intermezzo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zolpidem:

Less Common

Rare

  • Difficulty with breathing
  • dizziness, lightheadedness, or fainting
  • falling
  • fast heartbeat
  • seeing, hearing, or feeling things that are not there
  • skin rash
  • swelling of the face
  • trouble sleeping
  • unusual excitement, nervousness, or irritability
  • wheezing

Some side effects of zolpidem may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Sleepiness or unusual drowsiness

Less Common

  • Abdominal or stomach pain
  • abnormal or decreased touch sensation
  • abnormal sensation of movement
  • appetite disorder
  • balance disorder
  • binge eating
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in hearing
  • chest discomfort
  • chills
  • confusion about identity, place, and time
  • constipation
  • continuous ringing, buzzing, or other unexplained noise in the ears
  • daytime drowsiness
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • difficulty with swallowing
  • discouragement
  • double vision
  • drugged feeling
  • dry mouth
  • earache
  • eye redness
  • false or unusual sense of well-being
  • feeling of unreality
  • feeling sad or empty
  • frequent bowel movements
  • frequent urge to urinate
  • headache
  • hearing loss
  • heartburn
  • hives or welts
  • itching ears
  • joint pain
  • lack of appetite
  • lack of feeling or emotion
  • lack or loss of self-control
  • lack or loss of strength
  • longer or heavier menstrual periods
  • loss of balance
  • loss of interest or pleasure
  • memory problems
  • mood swings
  • muscle aches, cramping, pain, or stiffness
  • nausea
  • nightmares or unusual dreams
  • redness of the skin
  • redness or soreness of the throat
  • sense of detachment from self or body
  • slowing of mental and physical activity
  • sneezing
  • stuffy or runny nose
  • swollen joints
  • tiredness
  • trouble concentrating
  • vision changes
  • vomiting

For Healthcare Professionals

Applies to zolpidem: oral spray, oral tablet, oral tablet extended release, sublingual tablet

General

There is evidence of a dose relationship for adverse effects, particularly for certain central nervous system and gastrointestinal events and in the elderly; in theory, these adverse effects should be less if this drug is taken immediately before bedtime.

Nervous system

Very common (10% or more): Headache (up to 19%), somnolence/drowsiness (up to 15%), dizziness (up to 12%)

Common (1% to 10%): Lethargy, lightheadedness, ataxia, vertigo, labyrinthitis, balance disorder, attention disturbance, hypoesthesia, ataxia, burning sensation, paresthesia, postural dizziness, tremor

Uncommon (0.1% to 1%): Syncope, cerebrovascular disorder, dysarthria, migraine, speech disorder, stupor, dysphagia, dysgeusia

Rare (less than 0.1%): Restless legs, rigors, abnormal gait, hypokinesia, hypotonia, neuralgia, neuritis, neuropathy, paresis, depressed level of consciousness[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, increased blood pressure

Uncommon (0.1% to 1%): Postural hypotension, hypertension, tachycardia, increased heart rate

Rare (less than 0.1%): Flushing, hypotension, hot flashes, angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, aggravated hypertension, myocardial infarction, phlebitis, varicose veins, ventricular tachycardia[Ref]

Dermatologic

Common (1% to 10%): Rash, urticaria, skin wrinkling

Uncommon (0.1% to 1%): Increased sweating/hyperhidrosis, pruritus, contact dermatitis

Rare (less than 0.1%): Acne, bullous eruption, dermatitis, furunculosis, photosensitivity reaction, angioneurotic edema[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dry mouth, abdominal pain, constipation, dyspepsia, hiccup, nausea, vomiting, gastroenteritis, abdominal discomfort, abdominal tenderness, frequent bowel movements, gastroesophageal reflux disease, flatulence

Rare (less than 0.1%): Altered saliva, increased saliva, tenesmus, enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, menorrhagia, dysuria, vulvovaginal dryness

Uncommon (0.1% to 1%): Menstrual disorder, vaginitis, cystitis, urinary incontinence, dysmenorrhea

Rare (less than 0.1%): Breast fibroadenosis, breast neoplasm, breast pain, micturition frequency, nocturia, polyuria, pyelonephritis, urinary retention[Ref]

Hypersensitivity

Common (1% to 10%): Allergy

Rare (less than 0.1%): Allergic reaction, aggravated allergy, anaphylactic shock

Frequency not reported: Angioedema, anaphylaxis[Ref]

Metabolic

Common (1% to 10%): Appetite disorder

Uncommon (0.1% to 1%): Anorexia, hyperglycemia, thirst

Rare (less than 0.1%): Decreased weight, increased appetite, gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, myalgia, neck pain, muscle cramp

Uncommon (0.1% to 1%): Leg cramps, arthritis, muscle spasms, involuntary muscle contractions

Rare (less than 0.1%): Tetany, arthrosis, muscular weakness, sciatica, tendinitis[Ref]

Ocular

Common (1% to 10%): Diplopia, abnormal vision, visual disturbance, eye redness, blurred vision, altered visual depth perception, asthenopia

Uncommon (0.1% to 1%): Eye irritation, eye pain, scleritis

Rare (less than 0.1%): Abnormal accommodation, glaucoma, periorbital edema, conjunctivitis, corneal ulceration, abnormal lacrimation, parosmia, photopsia[Ref]

Other

Common (1% to 10%): Influenza-like symptoms, chest pain, chest discomfort, asthenia, fatigue, tinnitus, contusion, increased body temperature, otitis externa, pyrexia/fever, neck injury, infection

Uncommon (0.1% to 1%): Pallor, pain, edema, falling, malaise, trauma, taste perversion

Rare (less than 0.1%): Face edema, pain, increased drug tolerance, otitis media, falls, Abscess herpes simplex/herpes zoster

Frequency not reported: Injuries (e.g., hip fractures, intracranial hemorrhages)[Ref]

Psychiatric

Common (1% to 10%): Depression, abnormal dreams, sleep disorder, insomnia, exacerbated/aggravated insomnia, hallucinations, agitation, nightmare, drugged feeling, confusion, euphoria, memory impairment, amnesia, anterograde amnesia, nervousness, disorientation, anxiety, psychomotor retardation, binge eating, depersonalization, disinhibition, mood swings, stress symptoms, apathy

Uncommon (0.1% to 1%): Decreased cognition, detached, difficulty concentrating, emotional lability, illusion, sleeping (after daytime dosing), irritability, drunk feeling, reduced alertness

Rare (less than 0.1%): Impotence, abnormal thinking, aggressive reaction, decreased libido, delusion, dementia, feeling strange, hysteria, intoxicated feeling, manic reaction, panic attacks, personality disorder, somnambulism, suicide attempts, neurosis, perceptual disturbances, restlessness, libido disorder, rages, inappropriate behavior

Frequency not reported: Psychoses, dependence

Postmarketing reports: Anger, abnormal behavior[Ref]

Respiratory

Common (1% to 10%): Sinusitis, pharyngitis, upper respiratory infection, lower respiratory infection, throat irritation, nasopharyngitis, dry throat, rhinitis

Uncommon (0.1% to 1%): Bronchitis, coughing, dyspnea

Rare (less than 0.1%): Pulmonary embolism, pulmonary edema, yawning, bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic function, increased ALT/SGPT

Rare (less than 0.1%): Bilirubinemia, increased AST/SGOT

Postmarketing reports: Acute hepatocellular, cholestatic, or mixed liver injury with or without jaundice[Ref]

Hematologic

Rare (less than 0.1%): Increased erythrocyte sedimentation rate (ESR), anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis[Ref]

Renal

Rare (less than 0.1%): Acute renal failure, renal pain[Ref]

Local

Postmarketing reports: Sublingual application site reactions (e.g., oral ulcers, blisters, mucosal inflammation)[Ref]

References

1. "Product Information. Zolpimist (zolpidem)." Magna Pharmaceuticals Inc, Louisville, KY.

2. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals, Somerset, NJ.

3. "Product Information. Intermezzo (zolpidem)." Purdue Pharma LP, Stamford, CT.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. "Product Information. Ambien (zolpidem)." sanofi-aventis, Bridgewater, NJ.

6. "Product Information. Ambien CR (zolpidem)." Sanofi-Synthelabo Inc, New York, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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