Zolpidem Side Effects

Brand Names: Ambien, Ambien CR, Edluar

Please note - some side effects for Zolpidem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zolpidem - for the Consumer

Zolpidem

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zolpidem:

Diarrhea; dizziness; drowsiness (including daytime drowsiness); "drugged" feeling; dry mouth; headache; nausea; nose or throat irritation; sluggishness; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, throat, or tongue; unusual hoarseness); abnormal thinking; behavior changes; chest pain; confusion; decreased coordination; difficulty swallowing or breathing; fainting; fast or irregular heartbeat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety, depression); severe dizziness; shortness of breath; suicidal thoughts or actions; vision changes.

Zolpidem Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zolpidem Extended-Release Tablets:

Dizziness; drowsiness (including daytime drowsiness); "drugged" feeling; dry mouth; headache; muscle aches; nausea; nose or throat irritation; sluggishness; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, throat, or tongue; unusual hoarseness); abnormal thinking; behavior changes; chest pain; confusion; decreased coordination; difficulty swallowing or breathing; fainting; fast or irregular heartbeat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety, depression); severe dizziness; shortness of breath; suicidal thoughts or actions; vision changes.

Zolpidem Side Effects - for the Professional

Zolpidem

• Most commonly observed adverse reactions were:
  Short-term (<10 nights): Drowsiness, dizziness, and diarrhea
  Long-term (28 – 35 nights): Dizziness and drugged feelings (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Vintage Pharmaceuticals, LLC at 1-800-444-4011 or FDA at 1-800-FDA-1088, or http://www.fda.gov/medwatch

Side Effects by Body System

General

In general, zolpidem 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.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, dyspepsia, anorexia, and diarrhea.

Other

Other side effects including tolerance to the pharmacologic effects of zolpidem 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.

Psychiatric

Psychiatric side effects including cases of psychotic reactions have been reported in association with zolpidem 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 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.

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 given alone at therapeutic doses.

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