Generic equivalent of zaleplon
2 SKUs available · Available to order · NABP accredited · DSCSA compliant
Zaleplon is the generic equivalent of the brand-name drug zaleplon. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Zaleplon through Premier Pharma with same-day fulfillment on in-stock SKUs.
INDICATIONS AND USAGE 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 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.
WARNINGS Complex Sleep Behaviors Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any subsequent use of zaleplon. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. a. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not reme…
ADVERSE REACTIONS The premarketing development program for zaleplon included zaleplon exposures in patients and/or normal subjects from 2 different groups of studies: approximately 900 normal subjects in clinical pharmacology/pharmacokinetic studies; and approximately 2,900 exposures from patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 450 patient exposure years. The conditions and duration of treatment with zaleplon varied greatly and included (in o…
Drug Interactions As with all drugs, the potential exists for interaction with other drugs by a variety of mechanisms. CNS-Active Drugs Ethanol: Zaleplon 10 mg potentiated the CNS-impairing effects of ethanol 0.75 g/kg on balance testing and reaction time for 1 hour after ethanol administration and on the digit symbol substitution test (DSST), symbol copying test, and the variability component of the divided attention test for 2.5 hours after ethanol administration. The potentiation resulted fro…
DOSAGE AND ADMINISTRATION The dose of zaleplon capsules should be individualized. The recommended dose of zaleplon capsules for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of zaleplon capsules appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower do…
Information for Patients A patient Medication Guide is also available for zaleplon. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions that they may have. Instruct patients and their families that zaleplon may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having s…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| ZALEPLON CAPS 10 MG 100 CAP | 2-Day |
| ZALEPLON CAPS 5 MG 100 CAP | 2-Day |
Premier Pharma stocks 2 Zaleplon SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Zaleplon is the generic equivalent of zaleplon. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Zaleplon in 10 mg/1, 5 mg/1 and CAPSULE.
Zaleplon carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
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