Edluar Side Effects

Generic Name: zolpidem

Note: This page contains information about the side effects of zolpidem. Some of the dosage forms included on this document 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: spray, tablet

In addition to its needed effects, some unwanted effects may be caused by zolpidem (the active ingredient contained in Edluar). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking zolpidem:

• Clumsiness or unsteadiness
• confusion
• depression

• 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

Minor Side Effects

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

• Sleepiness or unusual drowsiness

• 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]

Not all side effects for Edluar may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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