# Zolpidem

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DRUG INFORMATION

  ADULT
    - The recommended initial dose is 5 mg for women and either 5 or 10 mg for men,
      taken only once per night immediately before bedtime with at least 7 to 8 hours
      remaining before the planned time of awakening.
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and
      administration', retrieved 2026-08-29
    - If the 5 mg dose is not effective, the dose can be increased to 10 mg.
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and
      administration', retrieved 2026-08-29
    - In some patients, the higher morning blood levels following use of the 10 mg dose
      increase the risk of next-day impairment of driving and other activities that
      require full alertness [see Warnings and Precautions ( 5.2 )] .
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Zolpidem tartrate tablets are not recommended for use in children. Safety and
      effectiveness of zolpidem in pediatric patients below the age of 18 years have not
      been established. In an 8-week study in pediatric patients (aged 6 to 17 years)
      with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an
      oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease
      sleep latency compared to placebo.
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pediatric use',
      retrieved 2026-08-29
    - In an 8-week study in pediatric patients (aged 6 to 17 years) with insomnia
      associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution
      of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency
      compared to placebo.
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for zolpidem (ZOLPIDEM TARTRATE),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Patients with mild to moderate hepatic impairment do not clear the drug as rapidly
      as normal subjects.
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and
      administration', retrieved 2026-08-29
    - Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment as
      it may contribute to encephalopathy [see Warnings and Precautions ( 5.8 ), Use in
      Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )]. 2.3 Use with CNS
      Depressants Dosage adjustment may be necessary when zolpidem tartrate tablets are
      combined with other CNS-depressant drugs because of the potentially additive
      effects [see Warnings and Precautions ( 5.2 , 5.7 )] .
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended dose of zolpidem tartrate tablets in geriatric patients is 5 mg
      regardless of gender. 8.7 Hepatic Impairment The recommended dose of zolpidem
      tartrate tablets in patients with mild to moderate hepatic impairment is 5 mg once
      daily immediately before bedtime.
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Neonates born to mothers using zolpidem late in the third trimester
      of pregnancy have been reported to experience symptoms of respiratory depression
      and sedation [see Clinical Considerations and Data] .
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pregnancy',
      retrieved 2026-08-29
    - Published data on the use of zolpidem during pregnancy have not reported a clear
      association with zolpidem and major birth defects [see Data].
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pregnancy',
      retrieved 2026-08-29
    - Oral administration of zolpidem to pregnant rats and rabbits did not indicate a
      risk for adverse effects on fetal development at clinically relevant doses [see
      Data].
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Risk Summary Limited data from published literature report the presence of
      zolpidem in human milk.
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'nursing mothers',
      retrieved 2026-08-29
    - There are reports of excess sedation in infants exposed to zolpidem through
      breastmilk [see Clinical Considerations].
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'nursing mothers',
      retrieved 2026-08-29
    - There is no information on the effects of zolpidem on milk production.
      Source: US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'nursing mothers',
      retrieved 2026-08-29
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