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Indications and usage:

Ambien (Zolpidem Tartrate), a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia, dyssomnia, sleep disorders characterized by difficulties with sleep initiation.


Dosage and administration:

Use the lowest dose effective for the patient and must not exceed a total of 10 mg sedative tablets daily.

Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening.

Geriatric patients and patients with mild to moderate hepatic impairment: recommended dose is 5 mg for men and women.

Lower doses of CNS depressants may be necessary when taken concomitantly with Ambien.

The effect of zolpidem may be slowed if taken with or immediately after a meal.


Dosage forms and strengths:

Ambien, Belbien, Nitrest, Stilnoct, Zolfresh, Zoltrate (Zolpidem Tartrate) tablets 5 mg, 10 mg.

Stilnoct (Zolpidem Tartrate) extended release tablets 6.25 mg, 12.5 mg.


Contraindications:

Patients who have experienced complex sleep behaviors after taking Ambien.

Known hypersensitivity to zolpidem.


Warnings and precautions:

CNS-depressant effects: impairs alertness and motor coordination including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Instruct patients on correct use.

Need to evaluate for comorbid diagnoses: reevaluate if insomnia persists after 7 to 10 days of use.

Severe anaphylactic/anaphylactoid reactions: angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.

Abnormal thinking and behavioral changes: changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes.

Depression: worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to avoid intentional overdose.

Respiratory depression: consider this risk before prescribing in patients with compromisedrespiratory function.

Hepatic impairment: Avoid Ambien (Zolpidem Tartrate) tablets use in patients with severe hepatic impairment.

Withdrawal effects: symptoms may occur with rapid dose reduction or discontinuation.


Overdosage:

Signs and symptoms:

In postmarketing 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.

Recommended treatment

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.


Adverse reactions, side effects:

Most commonly observed adverse reactions of zolpidem tablets were:
Short-term ( < 10 nights): drowsiness, dizziness, and diarrhea. Long-term (28-35 nights): dizziness and drugged feelings.

To report suspected adverse reactions of Ambien (Zolpidem Tartrate) tablets, contact Sanofi pharmaceutical company or your local FDA.


Drug interactions:

CNS depressants, including alcohol: possible adverse additive CNS-depressant effects.

Imipramine: decreased alertness observed.

Chlorpromazine: impaired alertness and psychomotor performance observed.

CYP3A4 inducers (rifampin or St. John's wort): combination use may decrease effect.

Ketoconazole: combination use may increase effect.


Use in specific populations:

Pregnancy

May cause respiratory depression and sedation in neonates with exposure late in the third trimester.

Lactation

A lactating woman may pump and discard breast milk during treatment and for 23 hours after Zolpidem (Ambien, Belbien, Stilnox) administration.

Pediatric use

Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with attention-deficit/hyperactivity disorder.


Drug abuse and dependence:

Zolpidem Tartrate is classified as a controlled substance by local laws in some countries (for example, Schedule IV in the United States and Canada).


Patient counseling information:

Complex sleep behaviors

Instruct patients and their families that Ambien (Zolpidem Tartrate) tablets may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue this medication and notify their healthcare provider immediately if they develop any of these symptoms.

CNS-depressant effects and next-day impairment

Tell patients that Ambien has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.

Severe anaphylactic and anaphylactoid reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur.

Suicide

Tell patients to immediately report any suicidal thoughts.

Alcohol and other drugs

Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use Ambien (Zolpidem) tablets if they drank alcohol that evening or before bed.

Concomitant use with opioids

Inform patients and caregivers that potentially serious additive effects may occur if this medicine is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider.

Tolerance, abuse, and dependence

Tell patients not to increase the dose of Ambien on their own, and to inform you if they believe the drug "does not work".

Administration instructions

Patients should be counseled to take this drug right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Ambien (Zolpidem Tartrate) pills should not be taken with or immediately after a meal. Advise patients NOT to take this medication if they drank alcohol that evening.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with zolpidem. Advise patients that use of Ambien late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used this medicine during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness.

Lactation

Advise breastfeeding mothers using Zolpidem Tartrate (Ambien) tablets to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after this drug administration to minimize drug exposure to a breastfed infant.