Ambien CR 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 Ambien CR.

Some side effects of Ambien CR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem (the active ingredient contained in Ambien CR) and Get emergency medical help if you have any of these signs of an allergic reaction while taking zolpidem: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using zolpidem and call your doctor at once if you have:

• chest pain, fast or irregular heartbeat, feeling short of breath;

• trouble breathing or swallowing; or

• feeling like you might pass out.

Common side effects may include:

• daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;

• tired feeling, loss of coordination;

• stuffy nose, dry mouth, nose or throat irritation;

• nausea, constipation, diarrhea, upset stomach; or

• headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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 Ambien CR) 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.

Nervous system

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

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.

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 Ambien CR) 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.

Other

Other side effects including tolerance to the pharmacologic effects of zolpidem (the active ingredient contained in Ambien CR) 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.

Psychiatric

Psychiatric side effects including cases of psychotic reactions have been reported in association with zolpidem (the active ingredient contained in Ambien CR) therapy.

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 Ambien CR) doses of 20 mg (twice the usual dose) may cause apneic episodes in patients with obstructive sleep apnea.

Respiratory side effects have included respiratory depression which may occur at high doses. Upper respiratory infection and rhinitis have also been reported.

Cardiovascular

Cardiovascular side effects including palpitations have been reported in patients taking zolpidem (the active ingredient contained in Ambien CR)

Genitourinary

Genitourinary side effects including urinary incontinence and urinary tract infection have been reported.

Hepatic

Hepatic side effects include one case of hepatotoxicity associated with zolpidem (the active ingredient contained in Ambien CR) given alone at therapeutic doses.

Immunologic

Immunologic side effects including infection have been reported infrequently.

Musculoskeletal

Musculoskeletal side effects including arthralgia and myalgia have been reported.

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