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AMBIEN® CR (zolpidem tartrate) Side Effects
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AMBIEN CR (Zolpidem Tartrate Extended Release) Sleep Aid

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AMBIEN CR Side Effects & Adverse Reactions

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During treatment with AMBIEN CR at daily doses up to 12.5 mg for 3 weeks, the most commonly observed adverse events associated with the use of AMBIEN CR were4:

  • headache (19%)
  • somnolence (15%)
  • dizziness (12%)

In clinical trials with AMBIEN CR, 3.5% of 201 patients receiving 6.25 mg or 12.5 mg of AMBIEN CR discontinued treatment because of an adverse event. Events most commonly associated with discontinuation were somnolence (1.0%) and dizziness (1.0%).4

See Adverse Reactions in Elderly Patients
See Residual Effects

Incidences of Treatment-emergent Adverse Events in a 3-Week Placebo-controlled Clinical Trial in Adults

(Events reported by at least 1% of patients treated with AMBIEN CR and with an incidence greater than that seen in placebo-treated patients)

* Hallucinations included hallucinations NOS as well as visual and hypnagogic hallucinations.
† Memory disorders include: memory impairment, amnesia, anterograde amnesia.

Next: Adverse Reactions in Elderly Patients

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* Maximum benefit is $240 off, up to $20 off each prescription (up to 12 prescriptions), depending on your out-of-pocket costs. Not valid for patients participating in Medicare, Medicaid, government (public insurance) programs, or any private payor in the state of Massachusetts and where prohibited by law.

AMBIEN CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

IMPORTANT SAFETY INFORMATION

In elderly or debilitated patients, or patients with hepatic insufficiency, the recommended dose is 6.25 mg and patients should be closely monitored. Due to its rapid onset of action, patients should take AMBIEN CR right before going to bed and when ready for sleep. Patients should not take AMBIEN CR unless they are prepared to get a full night’s sleep (7 to 8 hours) to avoid residual effects. Until they know how it will affect their physical or mental performance upon awakening, patients should not drive or operate hazardous machinery after taking AMBIEN CR or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, as well as abnormal behaviors such as being more outgoing or aggressive than normal, confusion, agitation, and hallucinations may occur. AMBIEN CR should not be taken with alcohol as it may increase these abnormal behaviors. Discontinuation of AMBIEN CR should be strongly considered for patients reporting such complex behaviors. Angioedema may occur in patients taking AMBIEN CR and in rare cases may be fatal. Patients who develop angioedema should not be rechallenged. In primarily depressed patients, worsening of depression, including risk of suicidal thoughts or actions, including completed suicides, have been reported. The most commonly observed adverse effects in controlled clinical trials were headache, somnolence, and dizziness. Because individuals with a history of addiction or substance abuse are at increased risk of habituation and dependence, they should be under careful surveillance when receiving AMBIEN CR or any other hypnotic. AMBIEN CR is a Schedule IV controlled substance.

Please refer to the full prescribing information.