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AMBIEN® CR (zolpidem tartrate) Drug Interactions
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AMBIEN CR (Zolpidem Tartrate Extended Release) Sleep Aid

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AMBIEN CR Drug Interactions

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CNS-active drugs 4

Since the systematic evaluations of zolpidem in combination with other CNS-active drugs have been limited, careful consideration should be given to the pharmacology of any CNS-active drug to be used with zolpidem. Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem.

An immediate-release formulation of zolpidem tartrate was evaluated in healthy subjects in single-dose interaction studies for several CNS drugs.

  • Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness.
  • Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.
  • A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration.
  • An additive effect on psychomotor performance between alcohol and zolpidem was demonstrated.
    See Warnings
  • A single-dose interaction study with zolpidem 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions.
  • When multiple doses of zolpidem and fluoxetine at steady-state concentrations were evaluated in healthy females, the only significant change was a 17% increase in the zolpidem half-life. There was no evidence of an additive effect in psychomotor performance.
  • Following five consecutive nightly doses of zolpidem 10 mg in the presence of sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem Cmax was significantly higher (43%) and Tmax was significantly decreased (53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem.

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Drugs that affect drug metabolism via cytochrome P450 4

Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes has not been carefully evaluated.

  • A randomized, double-blind, crossover interaction study in ten healthy volunteers between itraconazole (200 mg once daily for 4 days) and a single dose of zolpidem (10 mg) given 5 hours after the last dose of itraconazole resulted in a 34% increase in AUC0- of zolpidem. There were no significant pharmacodynamic effects of zolpidem on subjective drowsiness, postural sway, or psychomotor performance.
  • A randomized, placebo-controlled, crossover interaction study in eight healthy female subjects between five consecutive daily doses of rifampin (600 mg) and a single dose of an immediate-release formulation of zolpidem tartrate (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (–73%), Cmax (–58%), and T1/2 (–36%) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem.
  • A randomized double-blind crossover interaction study in twelve healthy subjects showed that co-administration of a single 5 mg dose of immediate-release zolpidem tartrate with ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased Cmax of zolpidem by a factor of 1.3 and increased the total AUC of zolpidem by a factor of 1.7 compared to zolpidem alone and prolonged the elimination half-life by approximately 30% along with an increase in the pharmacodynamic effects of zolpidem.

    Caution should be used when ketoconazole is given with zolpidem and consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together. Patients should be advised that use of AMBIEN CR with ketoconazole may enhance the sedative effects.

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Other drugs with no interaction with zolpidem 4

A study involving cimetidine/ zolpidem and ranitidine/ zolpidem combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.

Zolpidem had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in normal subjects.

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Drug-laboratory test interactions 4

Zolpidem is not known to interfere with commonly employed clinical laboratory tests. In addition, clinical data indicate that zolpidem does not cross-react with benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screens.

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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.