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: oral spray, oral tablet, oral tablet extended release

Other dosage forms:

• spray, tablet

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

• Chest pain
• confusion
• 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

Less common or rare

• Anxiety
• bladder pain
• bloody or cloudy urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cold sweats
• crying
• decreased awareness or responsiveness
• depersonalization
• difficult, burning, or painful urination
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• dry mouth
• dysphoria
• euphoria
• fainting
• frequent urge to urinate
• hyperventilation
• irregular heartbeats
• irritability
• lower back or side pain
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• seeing, hearing, or feeling things that are not there
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• trembling or shaking of the hands or feet

Rare

• Attack, assault, or force
• black, tarry stools
• change in walking and balance
• clumsiness or unsteadiness
• cough
• delusions
• dementia
• difficulty swallowing
• dizziness
• hives, itching, or skin rash
• lack of feeling or emotion
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• thoughts of killing oneself or changes in behavior
• tightness in the chest
• troubled breathing with exertion
• uncaring
• unusual bleeding or bruising

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

• Drowsiness
• headache
• muscle aches
• sleepiness or unusual drowsiness
• stuffy or runny nose

Less Common

• Abdominal or stomach discomfort
• acid or sour stomach
• back pain
• being forgetful
• belching
• body aches or pain
• congestion
• diarrhea
• difficulty having a bowel movement (stool)
• 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
• nausea
• pain or tenderness around the eyes and cheekbones
• seeing double
• sensation of spinning
• tender, swollen glands in the neck
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• voice changes

Less common or rare

• Bad, unusual, or unpleasant (after) taste
• breast pain
• change in taste
• changes in patterns and rhythms of speech
• increased sweating
• itching of the vagina or genital area
• pain during sexual intercourse
• paleness of the skin
• slurred speech
• thick, white vaginal discharge with no odor or with a mild odor
• vomiting

Rare

• Blemishes on the skin
• blindness
• blurred vision
• change in near or distance vision
• decreased interest in sexual intercourse
• difficulty in focusing 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
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• pimples
• redness of the face, neck, arms, and occasionally, upper chest
• redness or other discoloration of the skin
• severe sunburn
• stomach upset
• straining while passing stool
• tearing
• weight loss

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]

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.

Medical Disclaimer