দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
ZALEPLON (UNII: S62U433RMH) (ZALEPLON - UNII:S62U433RMH)
Unit Dose Services
ZALEPLON
ZALEPLON 10 mg
ORAL
PRESCRIPTION DRUG
Zaleplon Capsules are indicated for the short-term treatment of insomnia. Zaleplon Capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see CLINICAL PHARMACOLOGY , Clinical Trials ). They have not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment. Hypersensitivity to zaleplon or any excipients in the formulation (see also PRECAUTIONS ). Zaleplon is classified as a Schedule IV controlled substance by federal regulation. Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be prod
Product: 50436-1006 NDC: 50436-1006-1 30 CAPSULE in a BOTTLE
Abbreviated New Drug Application
ZALEPLON- ZALEPLON CAPSULE Unit Dose Services ---------- MEDICATION GUIDE ZALEPLON (ZAL-e-plon) CAPSULES USP CIV Read this Medication Guide before you start taking zaleplon capsules and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. You and your doctor should talk about zaleplon capsules when you start taking them and at regular checkups. What is the most important information I should know about zaleplon capsules? After taking zaleplon capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with zaleplon capsules. Reported activities include: • driving a car (“sleep-driving”) • making and eating food • talking on the phone • having sex • sleep-walking Important: 1. Take zaleplon capsules exactly as prescribed • Do not take more zaleplon capsules than prescribed. • Take zaleplon capsules right before you get in bed, not sooner. 2. Do not take zaleplon capsules if you: • drink alcohol • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take zaleplon capsules with your other medicines • cannot get a full night’s sleep 3. Call your doctor right away if you find out that you have done any of the above activities after taking zaleplon capsules. What are zaleplon capsules? Zaleplon capsules are a sedative-hypnotic (sleep) medicine. Zaleplon capsules are used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. Zaleplon capsules do not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night. Zaleplon capsules are not for children. সম্পূর্ণ নথি পড়ুন
ZALEPLON- ZALEPLON CAPSULE UNIT DOSE SERVICES ---------- ZALEPLON CAPSULES USP CIV 5268 5269 RX ONLY DESCRIPTION Zaleplon, USP is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. The chemical name of zaleplon is _N_-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-_N_-ethylacetamide. The structural formula is shown below. C H N O M.W. 305.34 Zaleplon, USP is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7. Zaleplon Capsules, USP contain zaleplon, USP as the active ingredient, and has the following inactive ingredients: colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40 aluminum lake, gelatin, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide. In addition, the 10 mg capsule contains FD&C blue #1. CLINICAL PHARMACOLOGY PHARMACODYNAMICS AND MECHANISM OF ACTION While zaleplon is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with the gamma-aminobutyric acid- benzodiazepine (GABA-BZ) receptor complex. Subunit modulation of the GABA-BZ receptor chloride channel macromolecular complex is hypothesized to be responsible for some of the pharmacological properties of benzodiazepines, which include sedative, anxiolytic, muscle relaxant, and anticonvulsive 17 15 5 effects in animal models. Other nonclinical studies have also shown that zaleplon binds selectively to the brain omega-1 receptor situated on the alpha subunit of the GABA /chloride ion channel receptor complex and potentiates t- butyl-bicyclophosphorothionate (TBPS) binding. Studies of binding of zaleplon to recombinant GABA receptors (α β γ [omega-1] a সম্পূর্ণ নথি পড়ুন