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Name
Ambien

Generic Name
Zolpidem

Dosage Form
Pills

Strengths
10mg

Packaging
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Description

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Description

AMBIEN is a sedative-hypnotic (sleep) medicine.
AMBIEN is used in adults for the short-term
treatment of a sleep problem called insomnia.

Indications

AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized
by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to
35 days in controlled clinical studies
The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final
formal assessments of sleep latency performed at the end of treatment.

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How To Take

Take AMBIEN exactly as prescribed. Do not
take more AMBIEN than prescribed for you.
• Take AMBIEN right before you get into bed.
• Do not take AMBIEN unless you are able to
stay in bed a full night (7-8 hours) before you
must be active again.
• For faster sleep onset, AMBIEN should NOT be
taken with or immediately after a meal.
• Call your doctor if your insomnia worsens or is
not better within 7 to 10 days. This may mean
that there is another condition causing your
sleep problem.
• If you take too much AMBIEN or overdose, call
your doctor or poison control center right away,
or get emergency treatment.

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WARNINGS AND PRECAUTIONS

Need to evaluate for co-morbid diagnoses
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric
disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of
the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate
the presence of a primary psychiatric and/or medical illness that should be evaluated.
Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the
consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged
during the course of treatment with sedative/hypnotic drugs, including zolpidem.
Severe anaphylactic and anaphylactoid reactions
Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients
after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some
patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting
that suggest anaphylaxis. Some patients have required medical therapy in the emergency
department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur
and be fatal. Patients who develop angioedema after treatment with zolpidem should not be
rechallenged with the drug
Abnormal thinking and behavioral changes
A variety of abnormal thinking and behavior changes have been reported to occur in association
with the use of sedative/hypnotics. Some of these changes may be characterized by decreased
inhibition (e.g., aggressiveness and extroversion that seemed out of character), similar to effects
produced by alcohol and other CNS depressants. Visual and auditory hallucinations have been
reported as well as behavioral changes such as bizarre behavior, agitation and depersonalization.
In controlled trials, < 1% of adults with insomnia who received zolpidem reported hallucinations.
In a clinical trial, 7.4% of pediatric patients with insomnia associated with attentiondeficit/hyperactivity
disorder (ADHD), who received zolpidem reported hallucinations [see Use
in Specific Populations (8.4)].
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of
a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics,
including zolpidem. These events can occur in sedative-hypnotic-naive as well as in
sedative-hypnotic-experienced persons. Although behaviors such as “sleep-driving” may occur
with Ambien alone at therapeutic doses, the use of alcohol and other CNS depressants with
Ambien appears to increase the risk of such behaviors, as does the use of Ambien at doses
exceeding the maximum recommended dose. Due to the risk to the patient and the community,
discontinuation of Ambien should be strongly considered for patients who report a
“sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making
phone calls, or having sex) have been reported in patients who are not fully awake after taking a
sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events.
Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably
In primarily depressed patients, worsening of depression, including suicidal thoughts and actions
(including completed suicides), has been reported in association with the use of
sedative/hypnotics.
It can rarely be determined with certainty whether a particular instance of the abnormal
behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying
psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or
symptom of concern requires careful and immediate evaluation.

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Contraindications

Ambien is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any
of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and
angioedema.

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Additional information

Quantity

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