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

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Overdose

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Signs and symptoms of AMBIEN CR overdose 4

In post-marketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise and fatal outcomes have been reported.4

Recommended treatment 4

General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed.

Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions).

As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed.

Hypotension and CNS depression should be monitored and treated by appropriate medical intervention.

Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs.

The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable.

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

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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.

AMBIEN CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. AMBIEN CR is not indicated for the treatment of GAD or MDD.

Due to its rapid onset of action, patients should take AMBIEN CR right before going to bed and when ready for sleep.

IMPORTANT SAFETY INFORMATION

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. Therefore, AMBIEN CR should be administered with caution to patients exhibiting signs or symptoms of depression, in whom suicidal tendencies may be present and protective measures may be required. Intentional overdosage is more common in this group of patients; the least amount of drug that is feasible should be prescribed for the patient at any one time.The most commonly observed adverse events in controlled clinical trials were headache, somnolence, and dizziness.

Please refer to the full prescribing information.