くすりのしおり

Internal
Published: 6/2012

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
ZOLPIDEM TARTRATE Tablets 5mg "DK"
 Active ingredient:
Zolpidem tartrate
 Dosage form:
slightly orange tablet, with a split line, φ 6.6mm, thickness 2.7mm
 Print on wrapping:
ゾルピデム酒石酸塩錠5mg「DK」, 入眠剤, 5, ZtL, ZOLPIDEM TARTRATE 5 「DK」, 就寝直前服用

Effects of this medicine

This medicine enhances the suppressive mechanism of the GABA system by acting on the benzodiazepine receptors in the central nervous system, thus exerting hypnotic and sedative effects.
It is usually used for the treatment of insomnia (excluding insomnia resulting from schizophrenia or manic-depressive psychosis).

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have liver disorders, myasthenia gravis, acute narrow-angle glaucoma, decreased respiratory function (due to cor pulmonale, pulmonary emphysema, bronchial asthma or acute phase cerebrovascular disorders, etc.)
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, for adults, take 1-2 tablets(5-10mg of the active ingredient) at a time just before bedtime. For patients who newly start the medicine, treatment should be started at a dose of 1 tablet (5mg) at a time. The dosage may be adjusted according to age, symptoms and disease; however, the daily dose should not be exceeded 2 tablets (10mg). Strictly follow the instructions.
  • In the following cases, since the medicine may cause amnesia, do not take this medicine: if you cannot take enough time to get started activities after getting up on the next morning or if you have to get up for temporarily work in the middle of the sleeping.
  • If you miss a dose, you may take the missed dose in case you can take enough time to get started activities after getting up. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • If you are taking this medicine continuously, do not change the dose or stop taking this medicine on your own judgment unless your doctor instructs you to do so. It may rather cause side effects.

Precautions while taking this medicine

  • Alcohol intake just before or after taking this medicine may enhance a decrease in mental function, perception or motor function. Avoid drinking alcohol.
  • This medicine may cause drowsiness, decreased attention/decreased concentration/diminished reflex movement, when the effects of the medicine persist after the following day. Do not drive a car, work at heights or operate dangerous machinery.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, itch, stagger, drowsiness, headache, fatigue, feeling of residual sleepiness and nausea. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • unable to stop taking the medicine, anxious feeling and inability to sleep when reducing the dose or discontinuing the medicine [addiction, withdrawal symptoms]
  • hallucination, faint consciousness, judgment failure [psychological symptoms, impaired consciousness]
  • inability to recall events that occured before sleep or when the sleep was interrupted, dimmed consciousness [transient anterograde amnesia, twilight state]
  • shallow/fast breath, difficult breathing [respiratory depression]
  • generalized fatigability, nausea, yellowness in skin or conjunctiva [liver dysfunction, jaundice]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.