HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AMBIEN safely and effectively. See full prescribing information for
AMBIEN.
AMBIEN
®
(zolpidem tartrate) tablets, for oral use, C-IV
Initial U.S. Approval: 1992
WARNING: COMPLEX SLEEP BEHAVIORS
See full prescribing information for complete boxed warning.
Complex sleep behaviors including sleep-walking, sleep-driving, and
engaging in other activities while not fully awake may occur following
use of AMBIEN. Some of these events may result in serious injuries,
including death. Discontinue AMBIEN immediately if a patient
experiences a complex sleep behavior. (4, 5.1)
------------------------------RECENT MAJOR CHANGES----------------------------
Dosage and Administration (2.1) 2/2022
Warnings and Precautions (5.5) 2/2022
Warnings and Precautions (5.7) 2/2022
----------------------------INDICATIONS AND USAGE---------------------------
AMBIEN, a gamma-aminobutyric acid (GABA) A receptor positive
modulator, is indicated for the short-term treatment of insomnia characterized
by difficulties with sleep initiation. (1)
----------------------DOSAGE AND ADMINISTRATION-----------------------
Use the lowest dose effective for the patient and must not exceed a total of
10 mg daily (2.1)
Treatment should be as short as possible (2.1)
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 (2.1)
Geriatric patients and patients with mild to moderate hepatic impairment:
Recommended dose is 5 mg for men and women (2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with AMBIEN (2.3)
The effect of AMBIEN may be slowed if taken with or immediately after a
meal (2.4)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
5 mg and 10 mg tablets. Tablets not scored. (3)
-------------------------------CONTRAINDICATIONS------------------------------
Patients who have experienced complex sleep behaviors after taking
AMBIEN (4)
Known hypersensitivity to zolpidem (4)
----------------------WARNINGS AND PRECAUTIONS-------------------------
CNS-Depressant Effects: Impaired alertness and motor coordination
including risk of morning impairment. Risk increases with dose and use
with other CNS depressants and alcohol. Caution patients against driving and
other activities requiring mental alertness the morning after use. Instruct patients
on correct use. (5.2)
Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists
after 7 to 10 days of use. (5.3)
Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and
anaphylaxis have been reported. Do not rechallenge if such reactions occur.
(5.4)
Abnormal Thinking and Behavioral Changes: Changes including decreased
inhibition, bizarre behavior, agitation, and depersonalization have been
reported. Immediately evaluate any new onset behavioral changes. (5.5)
Depression: Worsening of depression or suicidal thinking may occur.
Prescribe the least amount of tablets feasible to avoid intentional overdose.
(5.6)
Respiratory Depression: Consider this risk before prescribing in patients
with compromised respiratory function. (5.7)
Hepatic Impairment: Avoid AMBIEN use in patients with severe hepatic
impairment. (5.8)
Withdrawal Effects: Symptoms may occur with rapid dose reduction or
discontinuation. (5.9, 9.3)
-----------------------------ADVERSE REACTIONS--------------------------------
Most commonly observed adverse reactions were:
Short-term (<10 nights): Drowsiness, dizziness, and diarrhea
Long-term (28-35 nights): Dizziness and drugged feelings (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis
U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
------------------------------DRUG INTERACTIONS-------------------------------
CNS depressants, including alcohol: Possible adverse additive CNS-
depressant effects (5.2, 7.1)
Opioids: Concomitant use may increase risk of respiratory depression (5.7,
7.1)
Imipramine: Decreased alertness observed (7.1)
Chlorpromazine: Impaired alertness and psychomotor performance
observed (7.1)
CYP3A4 inducers (rifampin or St. John’s wort): Combination use may
decrease effect (7.2)
Ketoconazole: Combination use may increase effect (7.2)
------------------------USE IN SPECIFIC POPULATIONS-----------------------
Pregnancy: May cause respiratory depression and sedation in neonates with
exposure late in the third trimester. (8.1)
Lactation: A lactating woman may pump and discard breast milk during
treatment and for 23 hours after AMBIEN administration. (8.2)
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. (5.5, 8.4)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 2/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: COMPLEX SLEEP BEHAVIORS 7.1 CNS-Active Drugs
1 INDICATIONS AND USAGE
7.2 Drugs that Affect Drug Metabolism via Cytochrome P450
2 DOSAGE AND ADMINISTRATION
8 USE IN SPECIFIC POPULATIONS
2.1 Dosage in Adults
8.1 Pregnancy
2.2 Special Populations
8.2 Lactation
2.3 Use with CNS Depressants
8.4 Pediatric Use
2.4 Administration
8.5 Geriatric Use
3 DOSAGE FORMS AND STRENGTHS
8.6 Gender Difference in Pharmacokinetics
4 CONTRAINDICATIONS
8.7 Hepatic Impairment
5 WARNINGS AND PRECAUTIONS
9 DRUG ABUSE AND DEPENDENCE
5.1 Complex Sleep Behaviors
9.1 Controlled Substance
5.2 CNS-Depressant Effects and Next-Day Impairment
9.2 Abuse
5.3 Need to Evaluate for Comorbid Diagnoses
9.3 Dependence
5.4 Severe Anaphylactic and Anaphylactoid Reactions
10 OVERDOSAGE
5.5 Abnormal Thinking and Behavioral Changes
10.1 Signs and Symptoms
5.6 Use in Patients with Depression
10.2 Recommended Treatment
5.7 Respiratory Depression
11 DESCRIPTION
5.8 Precipitation of Hepatic Encephalopathy
12 CLINICAL PHARMACOLOGY
5.9 Withdrawal Effects
12.1
Mechanism of Action
6 ADVERSE REACTIONS
12.2 Pharmacodynamics
6.1 Clinical Trials Experience
12.3 Pharmacokinetics
6.2 Postmarketing Experience
13 NONCLINICAL TOXICOLOGY
7 DRUG INTERACTIONS
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Reference ID: 4942373
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