País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ZALEPLON (UNII: S62U433RMH) (ZALEPLON - UNII:S62U433RMH)
DIRECT RX
ZALEPLON
ZALEPLON 10 mg
ORAL
PRESCRIPTION DRUG
Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY). It has 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). Controlled Substance Class Zaleplon is classified as a Schedule IV controlled substance by federal regulation. Abuse, Dependence, and Tolerance 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 speci
Zaleplon capsules 5 mg are available as hard gelatin capsules with light blue cap and light blue body imprinted with "U" on cap and "131" on the body in black ink along the horizontal axis. Bottles of 30's: NDC 29300-131-13 Bottles of 100's: NDC 29300-131-01 Bottles of 500's: NDC 29300-131-05 Zaleplon capsules 10 mg are available as hard gelatin capsules with dark blue cap and dark blue body imprinted with "U" on cap and "132" on the body in black ink along the horizontal axis. Bottles of 100's: NDC 29300-132-01 Bottles of 500's: NDC 29300-132-05 Bottles of 1000's: NDC 29300-132-10 STORAGE CONDITIONS Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [see USP]. Dispense in a light-resistant container as defined in the USP. Issue date: June 2008 PSEUSA041-00
Abbreviated New Drug Application
ZALEPLON- ZALEPLON CAPSULE DIRECT RX ---------- SPL MEDGUIDE SECTION Zaleplon Capsules C-IV Read this Medication Guide before you start taking Zaleplon 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 when you start taking it and at regular checkups. _____________________________________________________________________________________ ___________________________________________ What is the most important information I should know about Zaleplon? After taking Zaleplon, 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. Reported activities include: • driving a car ("sleep-driving") • making and eating food • talking on the phone • having sex • sleep-walking Important: 1. Take Zaleplon exactly as prescribed • Do not take more Zaleplon than prescribed. • Take Zaleplon right before you get in bed, not sooner. 2. Do not take Zaleplon 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 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. _____________________________________________________________________________________ ___________________________________________ What is Zaleplon? Zaleplon is a sedative-hypnotic (sleep) medicine. Zaleplon is used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. Zaleplon does not treat other symptoms of insomnia which include waking up too ea Leer el documento completo
ZALEPLON- ZALEPLON CAPSULE DIRECT RX ---------- ZALEPLON BOXED WARNING SECTION Zaleplon is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Zaleplon in a safe place to prevent misuse and abuse. Selling or giving away Zaleplon may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. DESCRIPTION SECTION Zaleplon 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. Its empirical formula is C17H15N5O, and its molecular weight is 305.34. The structural formula is shown below. Zaleplon 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 contain zaleplon as the active ingredient. Inactive ingredients consist of microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40 and black iron oxide. Zaleplon 5mg capsules also contain FD&C yellow #5. CLINICAL PHARMACOLOGY SECTION 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 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 GA Leer el documento completo