预约演示
更新于：2026-05-08
Zaleplon
扎来普隆
更新于：2026-05-08
概要
基本信息
药物类型 小分子化药 |
别名 3'-(3-Cyanopyrazolo(1,5-a)pyrimidin-7-yl)-N-ethylacetanilide、Accordion Pill Zaleplon、AP-ZP + [28] |
作用方式 调节剂 |
作用机制 GABAA receptor调节剂(γ-氨基丁酸 A 受体调节剂) |
在研适应症 |
非在研适应症- |
原研机构 |
在研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (1999-03-12), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C17H15N5O |
InChIKeyHUNXMJYCHXQEGX-UHFFFAOYSA-N |
CAS号151319-34-5 |
关联
19
项与 扎来普隆 相关的临床试验ChiCTR2500106874
Effect of zaleplon on Cognitive Function of Insomnia Patients: a randomized, controlled multi-centre study
ChiCTR2500099466
A multicenter, open-label, randomized controlled study of the efficacy and safety of zaleplon in combination with escitalopram in the treatment of mild to moderate depression with insomnia
ChiCTR2400087469
Study on effect of zaleplon capsules on subjective sleep quality and daytime function in patients with insomnia
100 项与 扎来普隆 相关的临床结果
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100 项与 扎来普隆 相关的转化医学
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100 项与 扎来普隆 相关的专利（医药）
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383
项与 扎来普隆 相关的文献（医药）2026-04-01CURRENT OPINION IN NEUROLOGY
Novel pharmacological therapies in development
Review
作者: Perucca, Emilio ; Perucca, Piero
Purpose of review:
To review progress in developing new pharmacological treatments for epilepsy, focusing on agents in clinical development.
Recent findings:
Over 30 different treatments are currently in clinical development, including novel small molecules, nucleic acid-based therapies, stem cells, microbiome-targeting bacteria, and repurposed drugs originally approved for other indications. Most of these treatments target rare epilepsies, particularly the developmental and epileptic encephalopathies, reflecting a development shift from common epilepsies to rare drug-resistant syndromes where unmet therapeutic needs are greatest. Most compounds are still in early development, and publicly accessible data consist mainly of conference reports and congress abstracts. For only two compounds (the K
v
7 activator azetukalner and the inhaled emergency treatment Staccato alprazolam) has evidence of efficacy been obtained from relatively large, well designed randomized placebo-controlled trials.
Summary:
New paradigms in drug discovery have brought to development innovative treatments with diverse targets and mechanisms of action. Many of these treatments are etiology-targeting and have the potential for disease-modifying effects. Although high-quality evidence is awaited, there is hope that over the next few years much needed life-changing therapies will be widely available for millions of people with disabling, drug-resistant epilepsies.
2026-02-01JAMA Psychiatry
Z-Drug Use in the First Trimester of Pregnancy and Risk of Congenital Malformations
Article
作者: Straub, Loreen ; Bateman, Brian T. ; Cohen, Lee S. ; Fung, Kelly ; Zhu, Yanmin ; Hernandez-Diaz, Sonia ; Gray, Kathryn J. ; Brill, Gregory ; Huybrechts, Krista F.
Importance:
Sleep disturbances are common in pregnancy and often treated with nonbenzodiazepine sedative hypnotics (Z-drugs). However, there is limited evidence on the fetal safety of Z-drugs.
Objective:
To evaluate whether Z-drug exposure in the first trimester of pregnancy is associated with an increased risk of congenital malformations.
Design, Setting, and Participants:
This US population-based cohort study evaluated health care utilization data from publicly insured beneficiaries in the Medicaid database (2000-2018) and commercially insured beneficiaries in the Merative MarketScan database (2003-2020). Participants were pregnant individuals and their liveborn infants, with maternal enrollment from 90 days before pregnancy to 30 days after delivery and infant enrollment for 90 days after birth unless death occurred sooner. Data analysis was performed from November 2023 to April 2025.
Exposure:
At least 1 dispensing of Z-drugs (zaleplon, eszopiclone, or zolpidem) in the first trimester of pregnancy compared with no dispensing.
Main Outcomes and Measures:
Major congenital malformations were identified using linked maternal and infant claims. The risks of any major congenital malformation, organ-specific malformations, and individual malformations in pregnancies with Z-drug exposure in the first trimester were compared with the risks in unexposed pregnancies. Relative risks (RRs) and 95% CIs were estimated. Propensity score fine stratification weights were used to control for confounders.
Results:
A total of 4 281 579 pregnancies were identified (mean [SD] maternal age at delivery, 25.2 [6.0] years in Medicaid and 31.6 [4.6] years in MarketScan). First-trimester Z-drug exposure was identified in 11 652 (0.5%) of 2 506 106 pregnancies in Medicaid and 10 862 (0.6%) of 1 775 473 pregnancies in MarketScan; 92.1% of exposed pregnancies had zolpidem exposure. The adjusted pooled RR for malformations overall was 1.01 (95% CI, 0.95-1.08). While adjusted pooled RRs were increased for abdominal wall defects (1.46; 95% CI, 0.89-2.38), tetralogy of Fallot (1.45; 95% CI, 0.86-2.46), and neural tube defects (1.62; 95% CI, 0.96-2.74), these associations were imprecisely estimated, driven by the Medicaid cohort and not replicated in the MarketScan cohort. Results were consistent across multiple sensitivity analyses.
Conclusions and Relevance:
These findings suggest that Z-drug exposure in the first trimester of pregnancy is not associated with a meaningful elevation in the risk of congenital malformations overall, nor was there a consistent signal observed for organ-specific or uncommon, individual malformations examined.
2026-01-01EPILEPSIA
Pharmacokinetics and tolerability of single‐dose Staccato® alprazolam in adolescents with epilepsy, and population pharmacokinetic analysis to support dose selection in adolescents
Article
作者: Liow, Kore Kai ; Klein, Pavel ; Aungaroon, Gewalin ; Sadek, Ahmed ; Wychowski, Thomas ; Roebling, Robert ; Schoemaker, Rik ; King, Aliceson ; Chanteux, Hugues ; Biton, Victor ; Phillips, Steven ; Rospo, Chiara C. ; Elshoff, Jan‐Peer
Abstract:
Objective:
Staccato® alprazolam is a hand‐held inhalation device that provides rapid systemic delivery of alprazolam through the intrapulmonary route. This trial explored the pharmacokinetics and tolerability of single‐dose Staccato alprazolam 2 mg in adolescents with epilepsy. Pharmacokinetic data were included in a population pharmacokinetic analysis to support adolescent dose selection in the Phase 3 trials.
Methods:
Multicenter, Phase 1, open‐label trial in adolescents (12–17 years) with focal, generalized, or focal and generalized epilepsy (UP0100/NCT04857307). A single dose of Staccato alprazolam 2 mg was administered in the morning following overnight fast. Pharmacokinetic data were used to update an existing population pharmacokinetic model in adults, which was used to investigate dosing in adolescents with epilepsy.
Results:
Fourteen patients (6 weighing <50 kg, 8 weighing ≥50 kg) were enrolled and administered Staccato alprazolam 2 mg. Individual plasma alprazolam concentration−time profiles indicated generally rapid absorption (median time to maximum plasma concentration [
Cmax
]: 10.5 [range: 2–120] min) with linear elimination. Geometric mean
Cmax
, area under the plasma concentration–time curve (AUC) from time 0 to last quantifiable concentration (AUC
0–t
), AUC from time 0 to infinity (AUC
inf
), and apparent total body clearance (CL/
F
) were similar across body weight groups (<50 kg, ≥50 kg). Three patients in the ≥50 kg group reported treatment‐emergent adverse events (TEAEs), including dysgeusia, somnolence, dizziness, cough, and hiccups. No severe or serious TEAEs were reported. Simulations of exposure estimates using the updated population pharmacokinetic model indicated similar exposure (AUC
inf
) for adolescents administered Staccato alprazolam 2 mg compared with the adult reference range, with a slight increase in
Cmax
at lower body weight.
Significance:
Alprazolam was rapidly absorbed in most adolescent patients with epilepsy following administration with the Staccato device. No clinically relevant differences between body weight groups were observed on primary pharmacokinetic or safety outcomes. Staccato alprazolam 2 mg was well tolerated. Overall, the present data support the use of Staccato alprazolam 2 mg in adolescents with epilepsy (12–17 years of age).
100 项与 扎来普隆 相关的药物交易
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研发状态
临床结果
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适应症
分期
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临床2期 | 20 | 簾艱壓獵網鹹憲觸繭衊(鑰遞膚艱壓網網蓋鹽製) = 淵鬱艱構鏇願顧齋築膚 鬱廠觸夢顧獵齋鏇觸鏇 (艱膚廠蓋艱膚繭網範壓, 4.5) 更多 | - | 2018-09-18 | |||
临床2期 | 400 | Inhaled Placebo (Inhaled Placebo) | 廠窪積獵衊艱艱壓築夢 = 襯簾鬱積築願鏇夢淵鹽 壓夢簾獵衊鏇膚鏇選網 (鏇鹽選遞顧鑰夢蓋鬱壓, 艱鹹壓積築艱積鏇糧壓 ~ 獵醖鏇繭願製蓋齋窪糧) 更多 | - | 2018-01-25 | ||
(Inhaled PCZ 5 mg) | 廠窪積獵衊艱艱壓築夢 = 膚範衊衊簾憲獵繭鹹憲 壓夢簾獵衊鏇膚鏇選網 (鏇鹽選遞顧鑰夢蓋鬱壓, 醖範淵鹽鏇獵襯鬱壓壓 ~ 網範遞蓋積願醖獵夢觸) 更多 | ||||||
临床1期 | - | 42 | (Zaleplon) | 襯醖獵鏇衊壓構鏇觸選(繭窪醖構夢遞鏇顧襯壓) = 繭蓋蓋遞襯鑰鬱築構憲 顧鹽顧範鹽簾襯膚齋願 (衊衊壓積餘鏇膚糧簾顧, 8.267) 更多 | - | 2009-08-18 | |
(Sonata®) | 襯醖獵鏇衊壓構鏇觸選(繭窪醖構夢遞鏇顧襯壓) = 窪廠選窪夢顧鏇選鏇餘 顧鹽顧範鹽簾襯膚齋願 (衊衊壓積餘鏇膚糧簾顧, 6.212) 更多 | ||||||
临床1期 | - | 40 | (Zaleplon) | 夢築膚選淵積顧淵簾鹽(願築窪鬱夢製網顧淵鹹) = 鹽襯願憲窪顧簾鏇蓋衊 選鑰壓壓膚齋鬱範餘積 (憲襯廠窪膚範繭齋衊餘, 12.369) 更多 | - | 2009-08-18 | |
(Sonata®) | 夢築膚選淵積顧淵簾鹽(願築窪鬱夢製網顧淵鹹) = 鹽願網觸網遞範簾繭鹹 選鑰壓壓膚齋鬱範餘積 (憲襯廠窪膚範繭齋衊餘, 12.763) 更多 |
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