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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
      Headache76
      Drowsiness2-
      Dizziness1-
   Gastrointestinal System
      Diarrhea1-
   Autonomic Nervous System
      Dry mouth31
   Body as a Whole
      Allergy41
      Back Pain32
      Influenza-like symptoms2-
      Chest pain1-
   Cardiovascular System  
      Palpitation2-
   Central and Peripheral Nervous System  
      Drowsiness85
      Dizziness51
      Lethargy31
      Drugged feeling3-
      Lightheadedness21
      Depression21
      Abnormal dreams1-
      Amnesia1-
      Sleep disorder1-
   Gastrointestinal System
      Diarrhea32
      Abdominal pain22
      Constipation21
   Respiratory System
      Sinusitis42
      Pharyngitis31
   Skin and Appendages
      Rash21

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