作者：Laurie Barclay, MD
出處：WebMD醫學新聞
December 23, 2008 — NovaDel藥廠日前發表指出，美國食品藥物管理局（FDA）已經核准口服噴霧劑型的zolpidem tartrate（Zolpimist）作為短期失眠治療，尤其是難以入眠型。
這個口服噴霧劑型有5、10-mg劑量劑型，可以經由口腔粘膜快速吸收zolpidem，這是Ambien（賽諾菲安萬特藥廠）的活性成分，是目前世界各地最常被處方用於治療失眠的鎮靜安眠藥物。
NovaDel藥廠CEO兼主席Steven B. Ratoff在一篇新聞稿中表示，我們相信FDA對於zolpimist的核准案提供了失眠病患一個重要的選擇，因為zolpimist可以從口腔黏膜快速吸收。
FDA的核准案是根據兩項隨機分派、開放標記、劑量範圍的研究結果，zolpimist噴霧與ambien錠劑在年輕人與老年健康受試者身上是生物相等的。這些研究比較相等劑量的zolpidiem經由噴霧給予或是錠劑投予的藥物動力學與安全性。研究結果以最高藥物血中濃度（Cmax）、藥物整體吸收（曲線下面積/AUC0-inf）、藥物吸收的速度、以及達到鎮靜的程度評估。NovaDel也呈交FDA來自計劃商業機構製造的註冊穩定度與確效過程的資料。
因為zolpidem口服噴霧的作用快速，建議於晚上就寢之前使用，這樣病患可以得到整晚的睡眠（7~8小時）；病患在服用這些藥物後的早晨，應特別注意或是完全避免駕車、操作危險機械、或是從事其他需要全神貫注的活動。
在控制組控制研究中，最常觀察到的不良反應是頭痛、嗜睡與頭暈。使用鎮靜安眠藥物可能造成複雜行為，包括夢遊，在沒有完全清醒的狀況下駕車或是飲食，而在事後沒有記憶。也可能發生嚴重的過敏反應。有這種反應的病患應該立即與他們的醫師聯絡，停止用藥，同時不要再繼續使用該藥物。
口服噴霧劑型的zolpidem tartrate適合短期使用，而在沒有先與醫師諮詢的情況下，應該避免延長任何鎮靜安眠藥物的使用時間。思考或是行為異常改變，或是持續有睡眠上的問題，都應該與他們的醫師聯繫，因為這些問題可能代表其他的醫療問題。雖然鎮靜安眠藥物不是鴉片類藥物，但仍有依賴的風險。
Oral Spray Form of Zolpidem Approved for Short-Term Insomnia Treatment
By Laurie Barclay, MD
Medscape Medical News
December 23, 2008 — NovaDel announced yesterday that the US Food and Drug Administration (FDA) has approved an oral spray formulation of zolpidem tartrate (Zolpimist) for the short-term treatment of insomnia characterized by difficulty with sleep initiation.
The oral spray, which is available in 5- and 10-mg dosing strengths, allows for fast absorption through the oral mucosa of zolpidem, which is also the active agent in Ambien (sanofi-aventis), currently the most prescribed sedative hypnotic worldwide for treatment of insomnia.
"We believe the FDA's approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa," Steven B. Ratoff, chairman of the board and interim CEO of NovaDel, said in a news release.
Findings supporting the FDA approval came from 2 randomized, open-label, dose-ranging studies showing bioequivalence between Zolpimist spray and Ambien tablets in young and elderly healthy volunteers. These studies compared the pharmacokinetics and safety of comparable doses of zolpidem given by oral spray or in tablets. Outcome measures included maximum drug concentration (Cmax), total exposure to drug (area-under-the-curve/AUC0-inf), speed of drug absorption, and level of sedation achieved. NovaDel also submitted to the FDA data from process validation and registration stability batches manufactured at the intended commercial facility.
Because of the rapid onset of action of the oral spray formulation of zolpidem, it should be taken immediately before bedtime on nights when patients can get a full night's sleep (7 – 8 hours). Patients should use extreme caution or completely avoid driving, operating hazardous machinery, or other activities requiring full alertness on the morning after taking any sleep medication. Medications for insomnia should not be taken with alcohol.
In controlled clinical trials, the most commonly observed adverse effects were headache, somnolence, and dizziness. Use of sedative hypnotics may result in complex behaviors including somnambulism — driving or eating while not fully awake — with amnesia for the event. Severe allergic reactions may also occur. Patients who experience such events should immediately contact their physician, discontinue use of the drug, and not be rechallenged.
The oral spray formulation of zolpidem tartrate is intended for short-term use, and prolonged use of any sedative hypnotic should be avoided without first consulting a physician. Patients with unusual changes in thinking or behavior or with persistent sleep problems should also consult their physician, because these problems may suggest another medical condition. Although sedative hypnotics are nonnarcotic, there is some risk for dependency.
[ 本帖最後由 goodcat1111 於 2009-1-7 10:33 編輯 ] |
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