藥碼
DAY01
藥名
Lemborexant 錠 5 mg
英文商品名
Dayvigo 錠 5 mg
中文商品名
達衛眠錠5毫克
螢幕名
Dayvigo 錠 5 mg
劑型
Tab
規格
成分
藥理分類
Misc. Anoxiolytic, Sedatives, Hypnotics
健保碼
ATC碼
藥品圖片
外觀圖片
適應症

治療失眠症。

Indicated for the treatment of insomnia.

藥理

lemborexant 為一種 orexin 受體拮抗劑,透過阻斷促進清醒狀態的神經經 orexin A 和 orexin B 與其受體 OX1R 和 OX2R 的結合,從而抑制清醒狀態的驅動。

Lemborexant is an orexin receptor antagonist that inhibits the binding of wake-promoting neuropeptides orexin A and orexin B to their receptors OX1R and OX2R, thereby suppressing the drive for wakefulness.

藥動學

吸收:Lemborexant 的血中濃度達最高時間(Tmax)約為 1 至 3 小時;半衰期約為 17–19 小時,劑量範圍內呈現劑量比例增加,穩定狀態下有 1.5 至 3 倍的蓄積。與高脂飲食併用會使 Cmax 減少 23%,Tmax 延遲 2 小時,AUC 增加 18%。

Absorption: Lemborexant reaches maximum plasma concentration (Tmax) in approximately 1 to 3 hours; its effective half-life is about 17–19 hours, with dose-proportional increases and accumulation of 1.5 to 3-fold at steady state. Co-administration with high-fat meals reduces Cmax by 23%, delays Tmax by 2 hours, and increases AUC by 18%.

分佈:分佈體積為 1970 公升,血漿蛋白結合率約 94%,血液與血漿濃度比為 0.65。

Distribution: Volume of distribution is 1970 L, plasma protein binding is approximately 94%, and the blood-to-plasma concentration ratio is 0.65.

代謝:主要代謝途徑為 CYP3A4,次要為 CYP3A5。主要代謝產物為 M10 (N-oxide),約佔血中藥物的 12%,其藥理活性微弱。

Metabolism: Lemborexant is primarily metabolized by CYP3A4 and to a lesser extent by CYP3A5. The major circulating metabolite is M10 (N-oxide), which represents about 12% of systemic exposure and contributes minimally to pharmacological activity.

排除:途徑以糞便為主(57.4%),其次為尿液(29.1%);原型藥物經尿排泄量少於 1%。

Excretion:The primary route of elimination is fecal (57.4%), followed by renal excretion (29.1%); less than 1% of unchanged drug is excreted in urine.

禁忌症

猝睡症患者禁用。

Contraindicated in patients with narcolepsy.

懷孕分類

在懷孕婦女中未進行充分且有良好對照的臨床試驗。僅在對胎兒的潛在效益大於潛在風險時使用。

Adequate and well-controlled studies in pregnant women have not been conducted. Use only if the potential benefit justifies the potential risk to the fetus.

哺乳分類

lemborexant 可分泌至人乳中,但量極少。應監測嬰兒是否有過度鎮靜的情況,並考慮母乳餵養的益處與潛在風險。

Lemborexant is excreted into human milk in small amounts. Monitor infants for excessive sedation and consider the benefits of breastfeeding along with potential risks.

副作用

常見的副作用為嗜睡。

The common adverse reaction is somnolence.

劑量和給藥方法

建議成人初始劑量為每晚 5 mg,臨睡前服用,並預留至少 7 小時的睡眠時間。若需要更大的效果且耐受良好,可增加至 10 mg。最大建議劑量為每日一次 10 mg。

The recommended initial dose for adults is 5 mg taken once nightly, immediately before bedtime, with at least 7 hours remaining before the planned time of awakening. If needed and well tolerated, the dose can be increased to 10 mg. The maximum recommended dose is 10 mg once daily.

小兒調整劑量

未確立 18 歲以下患者的安全性與有效性,不建議使用。

Safety and efficacy have not been established in patients under 18 years of age; use is not recommended.

腎功能調整劑量

對於輕度、中度或重度腎功能不全的患者,無需調整劑量。

No dose adjustment is necessary for patients with mild, moderate, or severe renal impairment.

肝功能調整劑量

輕度肝功能不全的患者無需調整劑量。中度肝功能不全的患者最大建議劑量為 5 mg。重度肝功能不全的患者不建議使用。

No dose adjustment is necessary for patients with mild hepatic impairment. For patients with moderate hepatic impairment, the maximum recommended dose is 5 mg. Use is not recommended in patients with severe hepatic impairment.

安定性
藥袋資訊
臨床用途
失眠症
主要副作用
嗜睡、疲勞
泡製方法
儲存方式
請置於 15-30℃ 乾燥處儲存
注意事項
其他說明
藥局 Y5 | 藥庫 口B22
藥品外觀
顏色
06
形狀
01
剝痕
N
標記1
L?M,5
標記2
其他
健保藥價
0
自費價
50
仿單
資料庫
健保給付規定