ゾルピデム酒石酸塩

危険有害性情報のコード(GHS)

• 絵表示(GHS)

  

• 注意喚起語

  Warning

• 危険有害性情報

  H302：飲み込むと有害

  H411：長期的影響により水生生物に毒性

• 注意書き

  P264：取扱い後は皮膚をよく洗うこと。

  P264：取扱い後は手や顔をよく洗うこと。

  P270：この製品を使用する時に、飲食または喫煙をしないこ と。

  P301+P312：飲み込んだ場合：気分が悪い時は医師に連絡する こと。

  P330：口をすすぐこと。

  P501：内容物/容器を．．．に廃棄すること。

ゾルピデム酒石酸塩 化学特性,用途語,生産方法

• 用途

  習慣性医薬品

• 効能

  催眠鎮静薬

• 商品名

  マイスリー (アステラス製薬)

• 化学的特性

  White or almost white, hygroscopic, crystalline powder.

• 使用

  Sedativehypnotic.

• 定義

  ChEBI: The hemitartrate salt of zolpidem.

• 薬物動態学

  Zolpidem exhibits a high selectivity for the α1 subunit. Its good bioavailability of 72% and rapid onset of action of approximately 1.4 hours following oral absorption can be attributed to its weak base (pKa = 6.2) and high lipophilicity (mlog P = 3.85). Its pharmacokinetic profile is characterized by rapid absorption from the gastrointestinal tract and a short elimination half-life because of rapid oxidative metabolism to inactive carboxylic acid metabolites. Zolpidem undergoes CYP3A4 (major), CYP2DG, and CYP2D6 hydroxylation of the aryl methyl groups, followed by further oxidation by aldehyde dehydrogenase to the ionic carboxylic acids, which are readily eliminated in the urine.
  Zolpidem demonstrates linear (dose-proportional) kinetics in the dose range of 5 to 20 mg. Although protein binding was 90%, no drug accumulation was observed following nightly dosing with 20-mg zolpidem tartrate tablets for 2 weeks. Food can prolong the time to peak concentration from 1.4 to 2.2 hours without affecting the half-life. These results suggest that for faster sleep onset, zolpidem should not be administered with or immediately after a meal. In the elderly, the dose should be 5 mg, because the elimination half-life is increased by 50% (from ~2 to ~3 hours). No accumulation was observed in elderly subjects following nightly oral dosing of 10 mg for 1 week. In patients with hepatic insufficiency, the plasma concentration doubled with an increase in the elimination half-life from approximately 2 to approximately 10 hours (range, 4–25 hours). Therefore, dosing should be modified in patients with hepatic insufficiency. No dosage adjustment should be necessary in patients with compromised renal function. Zolpidem is not hemodialyzable, but it does cross the placenta and into breast milk. Because of its longer elimination half-life (when compared to zaleplon), it may be preferred when sleep maintenance is a primary concern.

ゾルピデム酒石酸塩 上流と下流の製品情報

ゾルピデム酒石酸塩 生産企業

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