Edluar 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 Edluar.

In Summary

Common side effects of Edluar include: drowsiness. Other side effects include: hallucination, myalgia, visual hallucination, anxiety, and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to zolpidem: tablet

Other dosage forms:

• oral spray, oral tablet, oral tablet extended release

Along with its needed effects, zolpidem (the active ingredient contained in Edluar) 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

• Clumsiness or unsteadiness
• confusion
• depression

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

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

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

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

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

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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