ZOLPIDEM TARTRATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)

Disponibil de la:

St. Mary's Medical Park Pharmacy

INN (nume internaţional):

ZOLPIDEM TARTRATE

Compoziție:

ZOLPIDEM TARTRATE 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)] . Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. Zolpidem should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the zolpidem tartrate tablets maximum recommended human dose (MRHD) of 10 mg/day (approximately 8 mg/day zolpidem base); however, teratogenicity was not observed. When zolpidem was administered at oral doses of 4, 20, and 100 mg base/kg/day to pregnant rats during the period of organogenesis, dose-related decreases in fetal skull ossification occurred at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m 2 basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and 16 mg base/kg/day increased embryo-fetal death and incomplete fetal skeletal ossification occurred at the highest dose tested. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 10 times the MRHD on a mg/m 2 basis. Administration of zolpidem to rats at oral doses of 4, 20, and 100 mg base/kg/day during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m 2 basis. Zolpidem tartrate tablets have no established use in labor and delivery [see Pregnancy (8.1)]. Zolpidem is excreted in human milk. Caution should be exercised when zolpidem is administered to a nursing woman. Zolpidem is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established. In an 8-week study, in pediatric patients (aged 6 to 17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. Psychiatric and nervous system disorders comprised the most frequent (> 5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Warnings and Precautions (5.4)] . Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction. A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were ≥60 years of age. For a pool of U.S. patients receiving zolpidem at doses of ≤10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug related). A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem reported falls, including 28/30 (93%) who were ≥70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg. The dose of zolpidem tartrate tablets in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Warnings and Precautions (5.1)]. Women clear zolpidem tartrate from the body at a lower rate than men. C max and AUC parameters of zolpidem were approximately 45% higher at the same dose in female subjects compared with male subjects. Given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of zolpidem for adult women is 5 mg, and the recommended dose for adult men is 5 or 10 mg. In geriatric patients, clearance of zolpidem is similar in men and women. The recommended dose of zolpidem in geriatric patients is 5 mg regardless of gender. The recommended dose of zolpidem tartrate tablets in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime. Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration (2.2), Warnings and Precautions (5.7), Clinical Pharmacology (12.3)]. Zolpidem tartrate 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. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. Its characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common. Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo. Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. The following adverse events which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal were reported during U.S. clinical trials following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness and abdominal discomfort. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received.

Rezumat produs:

Zolpidem tartrate 10 mg tablets, USP are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and '10 MG' debossed on the other side and supplied as: NDCs 60760-288-30 BOTTLES OF 30 60760-288-60 BOTTLES OF 60 - INACTIVE Store at 20º to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59º to 86°F) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
St. Mary's Medical Park Pharmacy
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MEDICATION GUIDE
Zolpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV
Read the Medication Guide that comes with zolpidem tartrate tablets
before you start taking it and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking to your healthcare provider about your medical condition or
treatment.
What is the most important information I should know about zolpidem
tartrate tablets?
•
Do not take more zolpidem tartrate tablets than prescribed.
•
Do not take zolpidem tartrate tablets unless you are able to stay in
bed a full night (7 to 8 hours)
before you must be active again.
•
Take zolpidem tartrate tablets right before you get in bed, not
sooner.
Zolpidem tartrate tablets may cause serious side effects, including:
•
After taking zolpidem tartrate tablets, 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 zolpidem
tartrate tablets. Reported
activities include:
o driving a car ("sleep-driving")
o making and eating food
o talking on the phone
o having sex
o sleep-walking
Call your healthcare provider right away if you find out that you have
done any of the above activities
after taking zolpidem tartrate tablets.
Do not take zolpidem tartrate tablets if you:
•
drank alcohol that evening or before bed
•
took another medicine to help you sleep.
What are zolpidem tartrate tablets?
Zolpidem tartrate tablets are sedative-hypnotic (sleep) medicine.
Zolpidem tartrate tablets are used in
adults for the short-term treatment of a sleep problem called insomnia
(trouble falling asleep).
It is not known if zolpidem tartrate tablets are safe and effective in
children under the age of 18 years.
Zolpidem tartrate i

Caracteristicilor produsului

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
ST. MARY'S MEDICAL PARK PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLPIDEM TARTRATE
TABLETS.
ZOLPIDEM TARTRATE (USP-CIV) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992.
RECENT MAJOR CHANGES
Dosage and Administration, Special Populations (2.2)
8/2016
Warnings and Precautions, CNS Depressant Effects and Next-
Day Impairment (5.1)
12/2016
Warnings and Precautions, Precipitation of Hepatic
8/2016
Encephalopathy (5.7)
12/2016
INDICATIONS AND USAGE
Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A
agonist, are indicated for the short-
term treatment of insomnia characterized by difficulties with sleep
initiation. (1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient and must not exceed a
total of 10 mg daily (2.1)
Recommended initial dose is a single dose of 5 mg for women and a
single dose of 5 or 10 mg for men,
immediately before bedtime with at least 7 to 8 hours remaining before
the planned time of awakening
(2.1)
Geriatric patients and patients with mild to moderate hepatic
impairment: Recommended dose is 5 mg
for men and women (2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with zolpidem tartrate
tablets (2.3)
The effect of zolpidem tartrate tablets may be slowed if taken with or
immediately after a meal (2.4)
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
CNS depressant effects: Impairs alertness and motor coordination.
Instruct patients on correct use.
(5.1)
Need to evaluate for co-morbid diagnoses: Reevaluate if insomnia
persists after 7 to 10 days of use.
(5.2)
Severe anaphylactic/anaphylactoid reactions: Angioedema and
anaphylaxis have been reported. Do not
rechallenge if such reactions occur. (5.3)
"Sleep-driving" and