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Zolpidem Side Effects

In Summary

Commonly reported side effects of zolpidem include: dizziness and drowsiness. Other side effects include: myalgia, visual hallucination, anxiety, hallucination, and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

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

Other dosage forms:

Warning

Oral route (Tablet)

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem tartrate. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate immediately if a patient experiences a complex sleep behavior.

Side effects requiring immediate medical attention

Along with its needed effects, zolpidem 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

  • Chest pain
  • confusion about identity, place, and time
  • discouragement
  • false or unusual sense of well-being
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling sad or empty
  • fever
  • general feeling of discomfort or illness
  • irritability
  • lack of appetite
  • lightheadedness
  • loss of interest or pleasure
  • shakiness and unsteady walk
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual tiredness or weakness

Rare

  • Anxiety
  • attack, assault, or force
  • black, tarry stools
  • bladder pain
  • bloody or cloudy urine
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in walking and balance
  • chills
  • cold sweats
  • cough
  • crying
  • decreased awareness or responsiveness
  • deep or fast breathing with dizziness
  • delusions of persecution, mistrust, suspiciousness, or combativeness
  • difficult, burning, or painful urination
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  • dry mouth
  • fainting
  • false beliefs that cannot be changed by facts
  • feeling of unreality
  • fever
  • frequent urge to urinate
  • hives, itching, or skin rash
  • irregular heartbeat
  • irritability
  • lack of feeling or emotion
  • light-colored stools
  • lower back or side pain
  • nausea
  • numbness of the feet, hands, and around the mouth
  • pale skin
  • poor insight and judgment
  • problems with memory or speech
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • quick to react or overreact emotionally
  • rapidly changing moods
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • sense of detachment from self or body
  • severe sleepiness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • swollen glands
  • thoughts of killing oneself or changes in behavior
  • tightness in the chest
  • trouble recognizing objects
  • trouble thinking and planning
  • trouble walking
  • troubled breathing with exertion
  • uncaring
  • unusual bleeding or bruising
  • vomiting
  • yellow eyes or skin
  • unease or dissatisfaction with life

Get emergency help immediately if any of the following symptoms of overdose occur while taking zolpidem:

Symptoms of overdose

  • Change or loss of consciousness
  • difficult or troubled breathing
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • sleepiness or unusual drowsiness

Side effects not requiring immediate medical attention

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

Less common

  • Back pain
  • being forgetful
  • belching
  • body aches or pain
  • congestion
  • diarrhea
  • difficulty having a bowel movement
  • difficulty with moving
  • double vision
  • feeling of constant movement of self or surroundings
  • heartburn
  • hoarseness
  • indigestion
  • longer or heavier menstrual periods
  • loss of memory
  • muscle pain or stiffness
  • pain or tenderness around the eyes and cheekbones
  • seeing double
  • sensation of spinning
  • stomach discomfort
  • tender, swollen glands in the neck
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • voice changes

Rare

  • Bad, unusual, or unpleasant (after) taste
  • blemishes on the skin
  • blindness
  • blurred vision
  • breast pain
  • change in near or distance vision
  • change in taste
  • changes in patterns and rhythms of speech
  • decreased interest in sexual intercourse
  • difficulty in focusing the eyes
  • eye pain
  • feeling of warmth
  • frequent urge to defecate
  • inability to have or keep an erection
  • increased appetite
  • increased sensitivity of the skin to sunlight
  • increased sweating
  • itching of the vagina or genital area
  • lack or loss of strength
  • loss in sexual ability, desire, drive, or performance
  • pain during sexual intercourse
  • paleness of the skin
  • pimples
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness or other discoloration of the skin
  • severe sunburn
  • slurred speech
  • stomach upset
  • straining while passing stool
  • tearing
  • thick, white vaginal discharge with no odor or with a mild odor
  • weight loss

For Healthcare Professionals

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

General

The most commonly reported side effects included dizziness, headache, and somnolence.[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 23.5%), headache (up to 19%), somnolence (up to 15%)

Common (1% to 10%): Amnesia, amnestic effects, anterograde amnesia, ataxia, attention disturbance, balance disorder, burning sensation, cognitive disorders, daytime drowsiness, drowsiness, drugged feelings, hypoesthesia, involuntary muscle contractions, lethargy, lightheadedness, memory disorders, memory impairment, paresthesia, postural dizziness, tremor, vertigo

Uncommon (0.1% to 1%): Cerebrovascular disorder, decreased cognition, difficulty concentrating, dysarthria, migraine, sleeping (with daytime dosing), speech disorder, stupor, syncope, taste perversion

Rare (less than 0.1%): Abnormal gait, dementia, depressed level of consciousness, gait disturbance, hypokinesia, hypotonia, neuralgia, neuritis, neuropathy, paresis, parosmia, restless legs, sciatica

Frequency not reported: Central nervous system (CNS)-depressant effects, impaired concentration, next-day impairment, next day somnolence

Postmarketing reports: Dysgeusia, memory disturbances, reduced alertness[Ref]

Psychiatric

Common (1% to 10%): Abnormal dreams, agitation, anxiety, apathy, binge eating, confusion, depersonalization, depressed mood, depression, disinhibition, disorientation, euphoria, euphoric mood, exacerbated insomnia, hallucinations, inappropriate behavior, insomnia, major depression, mood swings, nervousness, nightmare, psychomotor retardation, restlessness, sleep disorder, stress symptoms

Uncommon (0.1% to 1%): Aggression, confusional state, detached, emotional lability, hypnagogic hallucinations, illusion, irritability, somnambulism, visual hallucinations

Rare (0.01% to 0.1%): Abnormal thinking, aggressive reaction, attempted suicide, decreased libido, delusion, hysteria, libido disorder, manic reaction, neurosis, panic attacks, personality disorder

Very rare (less than 0.01%): Dependence, withdrawal effects/symptoms

Frequency not reported: Abnormal behavior, abnormal thinking, aggravated depression, anger, behavior changes, complex behaviors, continuing depression, hallucinations not otherwise specified (NOS), psychosis

Postmarketing reports: Aggravated insomnia, other adverse behavioral effects, perceptual disturbances, rages[Ref]

Gastrointestinal

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

Uncommon (0.1% to 1%): Dysphagia

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

Other

Common (1% to 10%): Asthenia, chest discomfort, contusion, exposure to poisonous plant, fatigue, increased body temperature, labyrinthitis, neck injury, otitis externa, pyrexia, tinnitus

Uncommon (0.1% to 1%): Fall/falling, fever, malaise, trauma

Rare (0.01% to 0.1%): Feeling strange, face edema, increased tolerance, intoxicated feeling, otitis media, pain, rigors

Very rare (less than 0.01%): Rebound effect

Frequency not reported: Drug tolerance

Postmarketing reports: Drunk feeling[Ref]

Respiratory

Common (1% to 10%): Hiccup, lower respiratory infection, lower respiratory tract infection, nasopharyngitis, pharyngitis, rhinitis, sinusitis, throat irritation, upper respiratory infection, upper respiratory tract infection

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

Rare (less than 0.1%): Bronchospasm, epistaxis, hypoxia, laryngitis, pneumonia, pulmonary edema, pulmonary embolism, respiratory depression, yawning

Postmarketing reports: Cough, dry throat[Ref]

Ocular

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

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

Rare (0.01% to 0.1%): Abnormal accommodation, abnormal lacrimation, conjunctivitis, corneal ulceration, glaucoma, periorbital edema, photopsia

Very rare (less than 0.01%): Visual impairment[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, muscle cramp, myalgia, neck pain

Uncommon (0.1% to 1%): Arthritis, leg cramps, muscle spasms, muscle/muscular weakness

Rare (less than 0.1%): Arthrosis, tendinitis[Ref]

Genitourinary

Common (1% to 10%): Dysuria, menorrhagia, urinary tract infection, vulvovaginal dryness

Uncommon (0.1% to 1%): Cystitis, menstrual disorder, urinary incontinence, vaginitis

Rare (less than 0.1%): Breast pain, impotence, micturition frequency, nocturia, polyuria, urinary retention

Postmarketing reports: Dysmenorrhea[Ref]

Dermatologic

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

Uncommon (0.1% to 1%): Hyperhidrosis, increased sweating, pruritus

Rare (less than 0.1%): Acne, bullous eruption, dermatitis, furunculosis, photosensitivity reaction, purpura

Frequency not reported: Angioneurotic edema

Postmarketing reports: Contact dermatitis[Ref]

Immunologic

Common (1% to 10%): Infection, influenza, influenza-like symptoms

Rare (less than 0.1%): Abscess, herpes simplex, herpes zoster[Ref]

Cardiovascular

Common (1% to 10%): Increased blood pressure, palpitations

Uncommon (0.1% to 1%): Chest pain, edema, hypertension, pallor, postural hypotension, tachycardia

Rare (less than 0.1%): Aggravated hypertension, angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, flushing, hot flashes, hypotension, myocardial infarction, phlebitis, thrombosis, varicose veins, ventricular tachycardia

Postmarketing reports: Increased heart rate[Ref]

Metabolic

Common (1% to 10%): Anorexia, appetite disorder

Uncommon (0.1% to 1%): Hyperglycemia, thirst

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

Hypersensitivity

Common (1% to 10%): Allergy

Rare (less than 0.1%): Aggravated allergy, allergic reaction, anaphylactic shock

Frequency not reported: Angioedema, anaphylaxis, serious anaphylactic reactions, serious anaphylactoid reactions[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic function, elevated liver enzymes, increased ALT

Rare (less than 0.1%): Bilirubinemia, cholestatic liver injury, hepatocellular liver injury, increased alkaline phosphatase, increased AST, mixed liver injury

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

Hematologic

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

Renal

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

Oncologic

Rare (less than 0.1%): Breast fibroadenosis, breast neoplasm[Ref]

Local

Tongue paresthesia and sublingual erythema occurred in patients given sublingual tablet formulations.[Ref]

Rare (less than 0.1%): Injection-site inflammation

Frequency not reported: Transient paresthesia of the tongue, transient sublingual erythema[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

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

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

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

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

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

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

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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