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:

Torrent Pharmaceuticals Limited

INN (nume internaţional):

ZOLPIDEM TARTRATE

Compoziție:

ZOLPIDEM TARTRATE 5 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  - who have experienced complex sleep behaviors after taking zolpidem tartrate tablets [see Warnings and Precautions ( 5.1)] .  - with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.4)] . Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data] . Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see Data]. Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/neonatal adverse reactions Zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to zolpidem during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. Data Human data Published data from observational studies, birth registries, and case reports on the use of zolpidem during pregnancy do not report a clear association with zolpidem and major birth defects. There are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. These cases required artificial ventilation or intratracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated. Zolpidem has been shown to cross the placenta. Animal data Oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the maximum recommended human dose (MRHD) of 10 mg/day (8 mg zolpidem base) based on mg/m 2  body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times the MRHD based on mg/m 2  body surface area. Oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16 mg base/kg/day, which are approximately 2.5, 10, and 40 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times the MRHD based on mg/m 2 body surface area. Oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m 2 body surface area, delayed offspring growth and decreased survival at doses 25 and 120 times, respectively, the MRHD based on mg/m2 body surface area. Risk Summary Limited data from published literature report the presence of zolpidem in human milk. There are reports of excess sedation in infants exposed to zolpidem through breastmilk [see Clinical Considerations]. There is no information on the effects of zolpidem on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zolpidem and any potential adverse effects on the breastfed infant from zolpidem or from the underlying maternal condition. Clinical Considerations Infants exposed to zolpidem through breastmilk should be monitored for excess sedation, hypotonia, and respiratory depression. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after zolpidem administration in order to minimize drug exposure to a breast fed infant. 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 ( 5.5)] . 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 ( 5.2 ) ]. 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 ( 5.8), 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. Use of zolpidem tartrate tablets may lead to the development of physical and/or psychological dependence. The risk of dependence increases with dose and duration of treatment. The risk of abuse and dependence is also greater in patients with a history of alcohol or drug abuse. Zolpidem tartrate tablets should be used with extreme caution in patients with current or past alcohol or drug abuse. 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 and delirium. The following adverse events, which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal, were reported during clinical trials with zolpidem tartrate tablets 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. There have been postmarketing reports of abuse, dependence and withdrawal with zolpidem.

Rezumat produs:

Zolpidem tartrate 5 mg tablets, USP are red colored, capsule shaped tablets with the Torrent logo debossed on one side and '5 MG' debossed on the other side and supplied as: NDC Number Size 13668-007-30                                                                              bottle of 30 13668-007-90                                                                              bottle of 90 13668-007-01                                                                              bottle of 100 13668-007-05                                                                              bottle of 500 13668-007-10                                                                              bottle of 1000 13668-007-15                                                                              bottle of 1500 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: NDC Number Size 13668-008-30                                                                              bottle of 30 13668-008-90                                                                              bottle of 90 13668-008-01                                                                              bottle of 100 13668-008-05                                                                              bottle of 500 13668-008-10                                                                              bottle of 1000 13668-008-15                                                                              bottle of 1500 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
Torrent Pharmaceuticals Limited
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MEDICATION GUIDE
Zolpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV
What is the most important information I should know about zolpidem
tartrate tablets?
Zolpidem tartrate tablets may cause serious side effects, including:
• complex sleep behaviors . 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. These activities may
happen with zolpidem tartrate tablets
whether or not you drink alcohol or take other medicines that make you
sleepy. Some of these complex sleep
behaviors have caused serious injury and death. People taking zolpidem
tartrate tablets have reported:
o sleep-walking
o sleep-driving
o making and eating food
o talking on the phone
o having sex
Stop taking zolpidem tartrate tablets and tell your healthcare
provider right away if you find out that you
have done any of the above activities after taking zolpidem tartrate
tablets.
What are zolpidem tartrate tablets?
Zolpidem tartrate tablets is a prescription sleep medicine used for
the short-term treatment of adults who
have trouble falling asleep (insomnia).
• It is not known if zolpidem tartrate tablets is safe and effective
in children under the age of 18 years.
Zolpidem tartrate tablets is not
recommended for use in children under the age of 18 years.
• Zolpidem tartrate tablets is a federally controlled substance
(C-IV) because it can be abused or lead to
dependence. Keep
zolpidem tartrate tablets in a safe place to protect it from theft.
Never give your zolpidem tartrate tablets to
anyone else because it may cause
death or harm them. Selling or giving away this medicine is against
the law.
Do not take zolpidem tartrate tablets if you:
• have had complex sleep behaviors that happened after taking
zolpidem tartrate tablets in the past. See
“What is the most important
inform

Caracteristicilor produsului

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
TORRENT PHARMACEUTICALS LIMITED
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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 TABLETS, FOR ORAL USE C
INITIAL U.S. APPROVAL: 1992.
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF ZOLPIDEM
TARTARE TABLETS.
SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH.
DISCONTINUE
ZOLPIDEM TARTARE TABLETS IMMEDIATELY IF A PATIENT EXPERIENCES A
COMPLEX SLEEP
BEHAVIOR ( 4, 5.1).
RECENT MAJOR CHANGES
Dosage and Administration ( 2.1) 2/2022
Warnings and Precautions ( 5.5) 2/2022
Warnings and Precautions ( 5.7) 2/2022
INDICATIONS AND USAGE
Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A
receptor positive modulator, is
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)
Treatment should be as short as possible ( 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
Patients who have experienced complex sleep be