These highlights do not include all the information needed to use zolpidem tartrate safely and effectively. See full prescribing information for zolpidem tartrate tablets.Zolpidem Tartrate Tablets CIVInitial U.S. Approval: 1992
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
The dose of zolpidem tartrate tablets should be individualized.
2.1 Dosage in adults
2.2 Special populations
2.3 Use with CNS depressants
2.4 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Need to evaluate for co-morbid diagnoses
5.2 Severe anaphylactic and anaphylactoid reactions
5.3 Abnormal thinking and behavioral changes
5.4 Withdrawal effects
5.5 CNS depressant effects
5.6 Special populations
6 ADVERSE REACTIONS
- Serious anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.2)]
- Abnormal thinking, behavior changes, and complex behaviors [see Warnings and Precautions (5.3)]
- Withdrawal effects [see Warnings and Precautions (5.4)]
- CNS-depressant effects [see Warnings and Precautions (5.5)]
6.1 Clinical trials experience
Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.
Central and Peripheral Nervous System | ||
Headache | 7 | 6 |
Drowsiness | 2 | - |
Dizziness | 1 | - |
Gastrointestinal System | ||
Diarrhea | 1 | - |
Autonomic Nervous System | ||
Dry mouth | 3 | 1 |
Body as a Whole | ||
Allergy | 4 | 1 |
Back Pain | 3 | 2 |
Influenza-like symptoms | 2 | - |
Chest pain | 1 | - |
Cardiovascular System | ||
Palpitation | 2 | - |
Central and Peripheral Nervous System | ||
Drowsiness | 8 | 5 |
Dizziness | 5 | 1 |
Lethargy | 3 | 1 |
Drugged feeling | 3 | - |
Lightheadedness | 2 | 1 |
Depression | 2 | 1 |
Abnormal dreams | 1 | - |
Amnesia | 1 | - |
Sleep disorder | 1 | - |
Gastrointestinal System | ||
Diarrhea | 3 | 2 |
Abdominal pain | 2 | 2 |
Constipation | 2 | 1 |
Respiratory System | ||
Sinusitis | 4 | 2 |
Pharyngitis | 3 | 1 |
Skin and Appendages | ||
Rash | 2 | 1 |
7 DRUG INTERACTIONS
7.1 CNS-active drugs
7.2 Drugs that affect drug metabolism via cytochrome P450
7.3 Other drugs with no interaction with zolpidem
7.4 Drug-laboratory test interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
8.2 Labor and delivery
8.3 Nursing mothers
8.4 Pediatric use
8.5 Geriatric use
Dizziness | 3% | 0% |
Drowsiness | 5% | 2% |
Diarrhea | 3% | 1% |
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
10.1 Signs and symptoms
10.2 Recommended treatment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, mutagenesis, impairment of fertility
14 CLINICAL STUDIES
14.1 Transient insomnia
14.2 Chronic insomnia
14.3 Studies pertinent to safety concerns for sedatives/hypnotic drugs
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Severe anaphylactic and anaphylactoid reactions
17.2 Sleep-driving and other complex behaviors
17.3 Administration instructions
Patients should be counseled to take zolpidem tartrate right before they get into bed and only when they are able to stay in bed a full night (7 to 8 hours) before being active again. Zolpidem tartrate tablets should not be taken with or immediately after a meal. Advise patients NOT to take zolpidem tartrate when drinking alcohol.
17.4 Medication Guide
- driving a car ("sleep-driving")
- making and eating food
- talking on the phone
- having sex
- sleep-walking
Who should not take zolpidem tartrate?
- have a history of depression, mental illness, or suicidal thoughts
- have a history of drug or alcohol abuse or addiction
- have kidney or liver disease
- have a lung disease or breathing problems
- are pregnant, planning to become pregnant, or breastfeeding
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
zolpidem5mg