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: myalgia, hallucination, visual hallucination, nausea, and anxiety. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to zolpidem: oral tablet, oral tablet extended release

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:

• 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

• 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

• 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

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:

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

• 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

• 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

• 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

In general, zolpidem (the active ingredient contained in Edluar) is well-tolerated and causes little or no residual daytime effects in most young adult volunteers. Additionally, zolpidem does not significantly alter sleep architecture at recommended doses.

General side effects including fatigue have been reported.^[Ref]

Nervous system

Nervous system side effects most frequently have included visual disturbances, ataxia, and dizziness. Headache, drugged feeling, confusion, anterograde amnesia, excessive sedation, lightheadedness, delirium, nightmares, hallucinations, nervousness, and agitation have also been reported.^[Ref]

Chronic use in high doses and subsequent withdrawal may induce grand mal seizures. Cases of falls have been reported in elderly patients.^[Ref]

Hypersensitivity

Hypersensitivity side effects including rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem (the active ingredient contained in Edluar) Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.

Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zolpidem should not be rechallenged with the drug.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, dyspepsia, anorexia, and diarrhea. In clinical studies on the sublingual tablet, one patient developed transient sublingual erythema and another patient developed transient paresthesia of the tongue.^[Ref]

Other

Other side effects including tolerance to the pharmacologic effects of zolpidem (the active ingredient contained in Edluar) have been reported rarely. Withdrawal symptoms after either abrupt cessation or fast tapering may occur. Withdrawal symptoms may include agitation, restlessness, anxiety, depression, insomnia, tremor, nausea, abdominal discomfort, and sweating.

Other side effects associated with the oral spray have included dry mouth.

A case of sleep driving has also been reported.^[Ref]

Psychiatric

Psychiatric side effects including cases of psychotic reactions have been reported in association with zolpidem (the active ingredient contained in Edluar) therapy.^[Ref]

Respiratory

Zolpidem-induced respiratory depression may be responsive to flumazenil. Zolpidem-induced respiratory depression is generally not clinically significant at the usual hypnotic doses even in patients with impaired respiratory function.

One study has suggested that zolpidem (the active ingredient contained in Edluar) doses of 20 mg (twice the usual dose) may cause apneic episodes in patients with obstructive sleep apnea.^[Ref]

Respiratory side effects have included respiratory depression which may occur at high doses. Upper or lower respiratory tract infection and rhinitis have also been reported.^[Ref]

Cardiovascular

Cardiovascular side effects including palpitations have been reported in patients taking zolpidem (the active ingredient contained in Edluar) ^[Ref]

Genitourinary

Genitourinary side effects including urinary incontinence and urinary tract infection have been reported.^[Ref]

Hepatic

Hepatic side effects include one case of hepatotoxicity associated with zolpidem (the active ingredient contained in Edluar) given alone at therapeutic doses.^[Ref]

Immunologic

Immunologic side effects including infection have been reported infrequently.

Musculoskeletal

Musculoskeletal side effects including arthralgia and myalgia have been reported.

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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