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AMBIEN® CR (zolpidem tartrate)│Dosing & Safety Information

Dosing & Safety Information

More than 12 billion doses prescribed since launch 5

The safety and efficacy of zolpidem, the active ingredient in AMBIEN CR, has been established over 17 years of real-world use and more than 12 billion prescribed doses of AMBIEN CR.5

  • Adverse event profile similar to zolpidem tartrate.4,5,9
  • The US clinical trial experience of zolpidem tartrate does not reveal any clear evidence for withdrawal syndrome.4
  • During short-term treatment with zolpidem tartrate, the most commonly observed adverse effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%).9
  • In clinical trials, the most common adverse events for AMBIEN CR were headache, somnolence, and dizziness.4
  • AMBIEN CR can be prescribed for as long as medically necessary.

Long-term Use of AMBIEN CR

Results from a study on the long-term efficacy, safety, and tolerability of
AMBIEN CR.

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AMBIEN CR Dosing

Recommended dosage and administration guidelines for
AMBIEN CR.

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AMBIEN CR Warnings

Important issues to consider when diagnosing insomnia and prescribing AMBIEN CR.

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AMBIEN CR Side Effects & Adverse Reactions

Adverse events observed in adults and elderly patients.

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AMBIEN CR Drug Interactions

Results from multiple studies on the interaction of AMBIEN CR and other drugs.

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Abuse & Dependence

Information about abuse and addiction, and dependence and withdrawal.

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Overdose

Signs and symptoms, as well as recommended treatment, for overdose.

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Next: Long-term Use of AMBIEN CR

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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.

AMBIEN® (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

IMPORTANT SAFETY INFORMATION

In elderly or debilitated patients, or in patients with hepatic insufficiency or dysfunction, the recommended dose of AMBIEN CR is 6.25 mg and the recommended dose of AMBIEN is 5 mg. These patients should be closely monitored.

AMBIEN CR and AMBIEN both have rapid onset of action; therefore, patients should ingest right before going to bed and when ready for sleep. To avoid residual effects, patients should not take AMBIEN CR or AMBIEN unless they are prepared to get a full night’s sleep (7 to 8 hours). 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, AMBIEN, 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 or AMBIEN should not be taken with alcohol as they may increase these abnormal behaviors. Discontinuation of AMBIEN CR or AMBIEN should be strongly considered for patients reporting such complex behaviors. Angioedema may occur in patients taking AMBIEN CR or AMBIEN 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 of AMBIEN CR were headache, somnolence, and dizziness. During short-term treatment with AMBIEN, the most commonly observed adverse effects in controlled clinical trials were drowsiness, dizziness, and diarrhea. 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, AMBIEN, or any other hypnotic. Both AMBIEN CR and AMBIEN are Schedule IV controlled substances. Sedative hypnotics have produced withdrawal symptoms following abrupt discontinuation.

Please refer to the full prescribing information for AMBIEN CR.

Please refer to the full prescribing information for AMBIEN.