Ambien CR 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 Ambien CR.

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

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 Ambien CR). In the event that any of these side effects do occur, they may require medical attention.

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

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

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

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.

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

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 or lower respiratory tract 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web5)