zolpidem tartrate
Tablet · Oral, Sublingual
Uses
Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )] . Zolpidem Tartrate Capsules, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age ( 1 )
Dosage and administration
Zolpidem Tartrate Capsules are only available in 7.5 mg strength. Use another zolpidem tartrate immediate-release product for 5 mg or 10 mg dosage ( 2.1 ) Avoid use of Zolpidem Tartrate Capsules in geriatric patients ( 2.1 ) Recommended dosage of zolpidem tartrate (use the lowest effective zolpidem tartrate dosage): Females: The recommended starting dosage of zolpidem tartrate immediate-release in females is 5 mg once nightly. Use another zolpidem tartrate immediate-release product for dosage initiation in females ( 2.1 , 2.2 , 8.6 ) Males: The recommended starting dosage of zolpidem tartrate immediate-release in males is either zolpidem tartrate immediate-release 5 mg, Zolpidem Tartrate Capsules 7.5 mg, or zolpidem tartrate immediate-release 10 mg, once nightly. Use another zolpidem tartrate immediate-release product for 5 mg and 10 mg dosing ( 2.2 ) In both males and females: If a 5 mg nightly dose of another zolpidem tartrate immediate-release product is not effective, the zolpidem tartrate dosage may be increased to Zolpidem Tartrate Capsules 7.5 mg once nightly or 10 mg once nightly of another zolpidem tartrate immediate-release product. The maximum recommended dosage of zolpidem tartrate immediate-release is 10 mg once nightly ( 2.2 ) Zolpidem Tartrate Capsules are for short-term use only ( 2.3 ) Administer Zolpidem Tartrate Capsules orally once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening ( 2.4 ) Zolpidem Tartrate Capsules should not be taken with or immediately after a meal. Swallow whole. Do not open, crush, or chew ( 2.4 ) Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Capsules ( 2.5 ) 2.1 Important Dosage Information Zolpidem Tartrate Capsules are only available in a 7.5 mg strength. Use another zolpidem tartrate immediate-release product for the 5 mg or 10 mg dose of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products. Zolpidem Tartrate Capsules are not indicated in geriatric patients. Avoid use of Zolpidem Tartrate Capsules in geriatric patients because the recommended dosage in these patients cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength [see Use in Specific Populations ( 8.5 )] . Use another zolpidem tartrate product for geriatric patients. The recommended starting dosage for females is different than males because zolpidem clearance is lower in females [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . Do not use Zolpidem Tartrate Capsules to initiate zolpidem tartrate treatment in females because the recommended starting dosage in females cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength. Use another zolpidem tartrate immediate-release product to initiate treatment in females [see Dosage and Administration ( 2.2 )] . Avoid Zolpidem Tartrate Capsules in patients with mild or moderate hepatic impairment because the recommended dosage in such patients cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength [see Warnings and Precautions ( 5.8 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . Avoid any zolpidem tartrate use in patients with severe hepatic impairment because its use may contribute to encephalopathy [see Warnings and Precautions ( 5.8 ), Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] . 2.2 Recommended Dosage Use the lowest effective zolpidem tartrate dosage. For instructions on administration of Zolpidem Tartrate Capsules, see Dosage and Administration ( 2.4 ) . The recommended starting dosage of zolpidem tartrate immediate-release in females is 5 mg once nightly. Use another zolpidem tartrate immediate-release product for dosage initiation in females [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] . The recommended starting dosage of zolpidem tartrate immediate-release in males is either zolpidem tartrate immediate-release 5 mg, Zolpidem Tartrate Capsules 7.5 mg, or zolpidem tartrate immediate-release 10 mg, once nightly. In both males and females, if a 5 mg once nightly dose of another zolpidem tartrate immediate-release product is not effective, the zolpidem tartrate dosage may be increased to Zolpidem Tartrate Capsules 7.5 mg once nightly or 10 mg once nightly of another zolpidem tartrate immediate-release product. The maximum recommended dosage of zolpidem tartrate immediate-release is 10 mg once nightly. Zolpidem Tartrate Capsules should be taken as a single dose and should not be readministered during the same night. 2.3 Recommended Duration of Treatment Zolpidem Tartrate Capsules are for short-term use only. Re-evaluate the patient’s status during treatment because the risk of abuse and dependence increases with duration of treatment [see Drug Abuse and Dependence ( 9.3 )] . 2.4 Administration Instructions Administer Zolpidem Tartrate Capsules orally once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening [see Warnings and Precautions ( 5.2 )] . Zolpidem Tartrate Capsules should not be administered with food or immediately after a meal [see Clinical Pharmacology ( 12.3 )] . Swallow Zolpidem Tartrate Capsules whole; do not open, crush, or chew. 2.5 Dosage Modifications with CNS Depressants Dosage modifications may be necessary when Zolpidem Tartrate Capsules are combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions ( 5.2 , 5.7 )] . Use another zolpidem tartrate immediate-release product for the 5 mg dosage of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products.
Dosage forms and strengths
Capsules: 7.5 mg, hard gelatin capsules with "ALM" printed axially on the opaque light green cap and "775" printed axially on the opaque white body. All printing is in grey ink. Capsules: 7.5 mg ( 3 )
Contraindications
Zolpidem Tartrate Capsules are contraindicated in patients: who have experienced complex sleep behaviors after taking zolpidem [see Warnings and Precautions ( 5.1 )] . with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.4 )] . Patients who have experienced complex sleep behaviors after taking zolpidem ( 4 ) Known hypersensitivity to zolpidem ( 4 )
Warnings and precautions
5 WARNINGS AND PRECAUTIONS CNS-Depressant Effects: Impaired alertness and motor coordination including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring mental alertness the morning after use. Instruct patients on correct use ( 5.2 ) Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use ( 5.3 ) Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur ( 5.4 ) Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes ( 5.5 ) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of capsules feasible to avoid intentional overdose ( 5.6 ) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function ( 5.7 ) Precipitation of Hepatic Encephalopathy: Avoid zolpidem tartrate in patients with severe hepatic impairment ( 2.1 , 5.8 , 8.7 ) Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation ( 5.9 , 9.3 ) 5.1 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 Zolpidem Tartrate Capsules. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Postmarketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosage, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interactions ( 7 )] . Discontinue Zolpidem Tartrate Capsules immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 )] . 5.2 CNS-Depressant Effects and Next-Day Impairment Zolpidem tartrate, like other sedative-hypnotic drugs, has CNS-depressant effects. Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression [see Drug Interactions ( 7 )] . Dosage adjustments of zolpidem tartrate and of other concomitant CNS depressants may be necessary when Zolpidem Tartrate Capsules are administered with such agents because of the potentially additive effects. Use another zolpidem tartrate immediate-release product for the 5 mg dose of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products. The use of Zolpidem Tartrate Capsules with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Dosage and Administration ( 2.5 )] . The risk of next-day psychomotor impairment, including impaired driving, is increased if Zolpidem Tartrate Capsules are taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dosage is taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase the blood levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alertness if Zolpidem Tartrate Capsules are taken in these circumstances [see Dosage and Administration ( 2.5 ), Clinical Studies ( 14.2 )] . Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alertness, and impaired driving the morning after therapy. In order to minimize this risk a full night of sleep (7 to 8 hours) is recommended. Because Zolpidem Tartrate Capsules can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls. 5.3 Need to Evaluate for Comorbid Diagnoses Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of Zolpidem Tartrate Capsules treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem tartrate. 5.4 Severe Anaphylactic and Anaphylactoid Reactions Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem tartrate. Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Zolpidem Tartrate Capsules should not be rechallenged with zolpidem tartrate. 5.5 Abnormal Thinking and Behavioral Changes Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including zolpidem tartrate immediate-release.
Side effects
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions ( 5.1 )] CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions ( 5.2 )] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions ( 5.4 )] Abnormal Thinking and Behavior Changes [see Warnings and Precautions ( 5.5 )] Withdrawal Effects [see Warnings and Precautions ( 5.9 )] Most commonly observed adverse reactions: headache, drowsiness, dizziness, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almatica Pharma LLC at 1-877-447-7979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of Zolpidem Tartrate Capsules 7.5 mg for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults is based upon adequate and well-controlled studies of zolpidem tartrate tablets immediate-release [see Clinical Studies ( 14 )] . The results of these adequate and well-controlled studies are presented below. Adverse Reactions Leading to Discontinuation of Treatment Approximately 4% of 1,701 patients who received zolpidem tartrate tablets immediate-release at all doses in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%). Approximately 4% of 1,959 patients who received zolpidem tartrate tablets immediate-release at all doses in similar foreign trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%). Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem tartrate revealed that four of the seven discontinuations during double-blind treatment with zolpidem tartrate (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide. Most Commonly Observed Adverse Reactions in Controlled Trials During short-term treatment (up to 10 nights) with zolpidem tartrate tablets immediate-release at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem tartrate tablets immediate-release and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem tartrate-treated patients), dizziness (1%), and diarrhea (1%). Adverse Reactions Observed at an Incidence of ≥1% in Controlled Trials The following tables enumerate adverse reactions frequencies that were observed at an incidence equal to 1% or greater among zolpidem tartrate-treated patients with insomnia and at a greater incidence than placebo-treated patients in U.S. placebo-controlled trials. Table 1 was derived from results of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem tartrate tablets immediate-release. Table 1: Adverse Reactions (≥1% and > placebo) in Placebo-Controlled Clinical Trials Zolpidem Tartrate Tablets Immediate-Release Lasting up to 10 Nights (percentage of patients reporting) * Zolpidem Tartrate Capsules are available only as a 7.5 mg dosage strength. Body System Adverse Reaction Zolpidem Tartrate Tablets Immediate-Release (≤10 mg)* (N=685) % Placebo (N=473) % Central and Peripheral Nervous System Headache 7 6 Drowsiness 2 - Dizziness 1 - Gastrointestinal System Diarrhea 1 - Dose-Related Adverse Reactions There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem tartrate tablets immediate-release use, particularly for certain CNS and gastrointestinal adverse reactions. Adverse Reactions During the Premarketing Evaluation of Zolpidem Tartrate Immediate-Release Zolpidem tartrate immediate-release was administered to 3,660 patients in clinical trials throughout the U.S., Canada, and Europe. The frequencies presented, therefore, represent the proportions of the 3,660 patients exposed to zolpidem tartrate, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem tartrate immediate-release. All reported adverse reactions are included, except those already listed in the table above of adverse reactions in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with zolpidem tartrate, they were not necessarily caused by it. Adverse reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are defined as those that occurred in greater than 1/100 patients; infrequent adverse reactions are those that occurred in 1/100 to 1/1,000 patients; rare reactions are those that occurred in less than 1/1,000 patients. Autonomic nervous system: dry mouth; Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus. Body as a whole: back pain, chest pain, influenza-like symptoms; Frequent: asthenia.
Drug interactions
Table 2 presents clinically important drug interactions with zolpidem tartrate. Table 2: Clinically Important Drug Interactions with Zolpidem Tartrate Capsules Alcohol and Other CNS Depressants Clinical Impact Concomitant use of alcohol or other CNS depressants with zolpidem tartrate may lead to additive impairment of psychomotor performance and risk of CNS depression [see Clinical Pharmacology ( 12.3 )] . Intervention Dosage adjustments of Zolpidem Tartrate Capsules and of other concomitant CNS depressants may be necessary when Zolpidem Tartrate Capsules are coadministered because of the potentially additive effects. Use another zolpidem tartrate immediate-release product for the 5 mg dose of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products. The use of Zolpidem Tartrate Capsules with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 , 5.2 )] . Opioids Clinical Impact Concomitant administration of zolpidem tartrate and opioids may increase the risk of respiratory depression [see Warnings and Precautions ( 5.2 , 5.7 )] . Intervention Limit dosage and duration of concomitant use of Zolpidem Tartrate Capsules and opioids, and monitor patients closely for respiratory depression. Consider using another zolpidem tartrate immediate-release product for a lower zolpidem tartrate dose (5 mg) [see Dosage and Administration ( 2.5 )] . Imipramine and Chlorpromazine Clinical Impact Concomitant use of imipramine or chlorpromazine with zolpidem tartrate may lead to an additive effect of decreased alertness and psychomotor performance [see Clinical Pharmacology ( 12.3 )] . Intervention Consider using another zolpidem tartrate immediate-release product for a lower zolpidem tartrate dose (5 mg). Sertraline Clinical Impact Concomitant administration of zolpidem and sertraline increases exposure to zolpidem [see Clinical Pharmacology ( 12.3 )] . Intervention Consider using another zolpidem tartrate immediate-release product for a lower zolpidem tartrate dose (5 mg). CYP3A4 Inducers Clinical Impact Concomitant use with CYP3A4 inducers may decrease zolpidem exposure [see Clinical Pharmacology ( 12.3 )] . Intervention Concomitant use of Zolpidem Tartrate Capsules and CYP3A4 inducers is not recommended. CYP3A4 Inhibitors Clinical Impact Concomitant use with CYP3A4 inhibitors increased zolpidem exposure [see Clinical Pharmacology ( 12.3 )] . Intervention Consider using another zolpidem tartrate immediate-release product for a lower zolpidem tartrate dose. CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects. Dose adjustment may be necessary ( 2.5 , 5.2 , 7 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7 ) Imipramine: Decreased alertness observed ( 7 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7 ) CYP3A4 inducers: Combination use may decrease effect ( 7 ) CYP3A4 inhibitors: Combination use may increase effect ( 7 )
Use in specific populations
Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester ( 8.1 ) Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after Zolpidem Tartrate Capsule administration ( 8.2 ) Hepatic Impairment: Avoid use ( 2.1 , 8.7 ) Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder ( 5.5 , 8.4 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry. Risk Summary Neonates born to mothers using zolpidem tartrate 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 tartrate 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 Tartrate Capsules 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 tartrate during pregnancy do not report a clear association with zolpidem tartrate 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 tartrate 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 tartrate has been shown to cross the placenta. Animal Data Oral administration of zolpidem tartrate 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 zolpidem tartrate 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 tartrate 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/m 2 body surface area. 8.2 Lactation Risk Summary Limited data from published literature report the presence of zolpidem tartrate in human milk. There are reports of excess sedation in infants exposed to zolpidem tartrate through breastmilk [see Clinical Considerations] . There is no information on the effects of zolpidem tartrate on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Zolpidem Tartrate Capsules and any potential adverse effects on the breastfed infant from Zolpidem Tartrate Capsules or from the underlying maternal condition. Clinical Considerations Infants exposed to zolpidem tartrate 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 Tartrate Capsules administration in order to minimize drug exposure to a breast fed infant. 8.4 Pediatric Use Zolpidem Tartrate Capsules are not recommended for use in pediatric patients. The safety and effectiveness of Zolpidem Tartrate Capsules in pediatric patients 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%) adverse reactions observed with zolpidem tartrate versus placebo and included dizziness (24% vs 2%), headache (13% vs 9%), and hallucinations 7% vs. 0%) [see Warnings and Precautions (5.5)].
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry. Risk Summary Neonates born to mothers using zolpidem tartrate 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 tartrate 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 Tartrate Capsules 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 tartrate during pregnancy do not report a clear association with zolpidem tartrate 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 tartrate 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 tartrate has been shown to cross the placenta. Animal Data Oral administration of zolpidem tartrate 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 zolpidem tartrate 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 tartrate 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/m 2 body surface area.
Pediatric use
8.4 Pediatric Use Zolpidem Tartrate Capsules are not recommended for use in pediatric patients. The safety and effectiveness of Zolpidem Tartrate Capsules in pediatric patients 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%) adverse reactions observed with zolpidem tartrate versus placebo and included dizziness (24% vs 2%), headache (13% vs 9%), and hallucinations 7% vs. 0%) [see Warnings and Precautions (5.5)]. Ten (7%) pediatric patients treated with zolpidem tartrate discontinued treatment due to an adverse reaction.
Geriatric use
8.5 Geriatric Use Zolpidem Tartrate Capsules are not indicated in geriatric patients. Avoid use of Zolpidem Tartrate Capsules 7.5 mg in geriatric patients because necessary dosage adjustment is not possible with the available dosage strength. Adverse reactions related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs, including zolpidem, have been reported in geriatric patients [see Warnings and Precautions ( 5.2 )] . A total of 154 patients in controlled clinical trials in the U.S. and 897 patients in clinical trials outside the U.S. who received zolpidem tartrate were ≥60 years of age. In the pool of U.S. patients ≥60 years of age who received zolpidem tartrate at dosage of ≤10 mg or placebo (taken once nightly), the following adverse reactions occurred at an incidence of at least 3% in the zolpidem tartrate-treated patients and for which the incidence in zolpidem tartrate-treated patients was at least twice the incidence in placebo-treated patients, i.e., they could be considered drug related (see Table 3). Table 3: Adverse Reactions (≥3% and at least twice placebo) in Pooled Placebo-Controlled Clinical Trials Zolpidem Tartrate Immediate-Release in Adults ≥60 Years of Age * Zolpidem Tartrate Capsules are only available as a 7.5 mg dosage strength. Adverse Reaction Zolpidem (≤10 mg)* Placebo Dizziness 3% 0% Drowsiness 5% 2% Diarrhea 3% 1% A total of 30/1,959 (1.5%) zolpidem tartrate-treated non-U.S. patients reported falls, including 28/30 (93%) who were ≥70 years of age. Of these 28 patients, 23 (82%) received zolpidem tartrate dosages greater than the maximum recommended dosage (i.e., >10 mg once nightly). A total of 24/1,959 (1.2%) zolpidem tartrate-treated non-U.S. patients reported confusion, including 18/24 (75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) received zolpidem tartrate dosage greater than the maximum recommended dosage (i.e., >10 mg once nightly). Zolpidem Tartrate Capsules are not indicated for use in geriatric patients. Avoid use of Zolpidem Tartrate Capsules in geriatric patients. In several studies, T max , T 1/2 , and AUC of zolpidem tartrate were significantly higher in geriatric subjects when compared to younger adult subjects. In one study of 8 subjects (>70 years of age), the means for C max , T 1/2 , and AUC significantly increased by 50% (255 vs 384 ng/mL), 32% (2.2 vs 2.9 hr), and 64% (955 vs 1,562 ng∙hr/mL), respectively, as compared to adults (20 to 40 years of age) following a single 20 mg oral dose (two times the maximum recommended dose). Zolpidem Tartrate Capsules are not indicated for use in geriatric patients.
Overdosage
Signs and Symptoms In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported. Recommended Treatment General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem tartrate's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem tartrate overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem tartrate is not dialyzable. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Description
Zolpidem Tartrate Capsules 7.5 mg contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate. It has the following structure: Zolpidem tartrate is a white to off-white crystalline powder, hygroscopic that is slightly soluble in water, sparingly soluble in methanol alcohol, and practically insoluble in methylene chloride. It has a molecular formula of (C 19 H 21 N 3 O) 2 · C 4 H 6 O 6 and molecular weight of 764.87 g/mol. Zolpidem Tartrate Capsules are intended for oral administration and are available only in a 7.5 mg strength. The capsules contain 7.5 mg zolpidem tartrate, USP (equivalent to 6 mg zolpidem) and include the following inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and the colorants FD&C Blue #1, FD&C Red #40 and FD&C Yellow #6. structure
Mechanism of action
12.1 Mechanism of Action Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of transient insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.
How supplied
Zolpidem Tartrate Capsules 7.5 mg are hard gelatin capsules with “ALM” printed axially on the opaque light green cap and “775” printed axially on the opaque white body, and available as: NDC 52427-775-30, bottle of 30 capsules with child-resistant closure Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Complex Sleep Behaviors Instruct patients and their families that Zolpidem Tartrate Capsules may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue Zolpidem Tartrate Capsules and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning , Warnings and Precautions ( 5.1 )] . CNS-Depressant Effects and Next-Day Impairment Advise patients that Zolpidem Tartrate Capsules has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Warnings and Precautions ( 5.2 )] . Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Warnings and Precautions ( 5.4 )] . Suicide Tell patients to immediately report any suicidal thoughts. Alcohol and other Drugs Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use Zolpidem Tartrate Capsules if they drank alcohol that evening or before bed. Concomitant Use with Opioids Inform patients and caregivers that potentially serious additive effects may occur if Zolpidem Tartrate Capsules are used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.2 , 5.7 ), Drug Interactions ( 7 )] . Tolerance, Abuse, and Dependence Tell patients not to increase the dose of zolpidem tartrate on their own, and to inform you if they believe the drug “does not work.” Administration Instructions Patients should be counseled to take Zolpidem Tartrate Capsules right before they get into bed and only when they are able to stay in bed a full night (7 to 8 hours) before being active again. Zolpidem Tartrate Capsules should not be taken with or immediately after a meal. Advise patients NOT to take Zolpidem Tartrate Capsules if they drank alcohol that evening. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Zolpidem Tartrate Capsules, and that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to zolpidem tartrate. Advise patients that use of Zolpidem Tartrate Capsules late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used Zolpidem Tartrate Capsules during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness [see Use in Specific Populations ( 8.1 )] . Lactation Advise breastfeeding mothers using Zolpidem Tartrate Capsules to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating female may consider pumping and discarding breastmilk during treatment and for 23 hours after Zolpidem Tartrate Capsules administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations ( 8.2 )] .
Label text from the FDA structured product label by Almatica Pharma LLC (revised Oct 9, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Zolpidem Tartrate in 118 products
zolpidem tartrate NDC products (118)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7434 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-6070 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-5804 | Zolpidem Tartrate 10 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-5095 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-3879 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-3878 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-2649 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-1023 | Zolpidem Tartrate 10 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 50090-1022 | Zolpidem Tartrate 5 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CIV |
| 80425-0060 | Zolpidem Tartrate 10 mg/1 Tablet, Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0061 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0513 | Zolpidem Tartrate 5 mg/1 Tablet, Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0059 | Zolpidem Tartrate 10 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0087 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0153 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0165 | Zolpidem Tartrate 5 mg/1 Tablet | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0301 | Zolpidem Tartrate 10 mg/1 Tablet | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 80425-0322 | Zolpidem Tartrate 5 mg/1 Tablet | Advanced Rx Pharmacy of Tennessee, LLC | ANDA · DEA CIV |
| 60687-838 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | American Health Packaging | ANDA · DEA CIV |
| 71610-913 | Zolpidem Tartrate 6.25 mg/1 Tablet, Film Coated, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-192 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-254 | Zolpidem Tartrate 12.5 mg/1 Tablet, Film Coated, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-730 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-839 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-904 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-915 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-152 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-151 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 71610-156 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA · DEA CIV |
| 76420-319 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-233 | Zolpidem Tartrate 5 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-263 | Zolpidem Tartrate 10 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-318 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-416 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-417 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-494 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Asclemed USA, Inc. | ANDA · DEA CIV |
| 76420-496 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Asclemed USA, Inc. | ANDA · DEA CIV |
| 65862-160 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA · DEA CIV |
| 65862-159 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA · DEA CIV |
| 51991-982 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Breckenridge Pharmaceutical, Inc. | ANDA · DEA CIV |
| 51991-981 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Breckenridge Pharmaceutical, Inc. | ANDA · DEA CIV |
| 71335-2085 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-2764 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-4708 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-4597 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-9629 | Zolpidem Tartrate 5 mg/1 Tablet, Coated | Bryant Ranch Prepack | ANDA · DEA CIV |
| 63629-3549 | Zolpidem Tartrate 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-1468 | Zolpidem Tartrate 12.5 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-1180 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA · DEA CIV |
| 71335-0154 | Zolpidem Tartrate 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CIV |
| 72162-2441 | Zolpidem Tartrate 12.5 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA · DEA CIV |
| 17224-970 | Zolpidem Tartrate 10 mg/1 Tablet | Calvin Scott & Co., Inc. | ANDA · DEA CIV |
| 55154-1398 | Zolpidem Tartrate 5 mg/1 Tablet | Cardinal Health 107, LLC | ANDA · DEA CIV |
| 62135-779 | Zolpidem Tartrate 10 mg/1 Tablet | Chartwell RX, LLC | ANDA · DEA CIV |
| 62135-778 | Zolpidem Tartrate 5 mg/1 Tablet | Chartwell RX, LLC | ANDA · DEA CIV |
| 72189-230 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | DIRECT RX | ANDA · DEA CIV |
| 61919-751 | Zolpidem Tartrate 5 mg/1 Tablet | Direct_Rx | ANDA · DEA CIV |
| 61919-663 | Zolpidem Tartrate 10 mg/1 Tablet | DirectRX | ANDA · DEA CIV |
| 51407-942 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 51407-941 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA · DEA CIV |
| 55700-357 | Zolpidem Tartrate 10 mg/1 Tablet | Lake Erie Medical DBA Quality Care Products LLC | ANDA · DEA CIV |
| 68180-780 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68180-779 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Lupin Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 43386-762 | Zolpidem Tartrate 1.75 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 43386-761 | Zolpidem Tartrate 3.5 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 0904-6082 | Zolpidem Tartrate 5 mg/1 Tablet | Major Pharmaceuticals | ANDA · DEA CIV |
| 16714-622 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA · DEA CIV |
| 16714-621 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA · DEA CIV |
| 82868-064 | Zolpidem Tartrate 10 mg/1 Tablet | Northwind Health Company, LLC | ANDA · DEA CIV |
| 82868-078 | Zolpidem Tartrate 10 mg/1 Tablet, Coated | Northwind Health Company, LLC | ANDA · DEA CIV |
| 68071-1887 | Zolpidem Tartrate 10 mg/1 Tablet | NuCare Pharmaceuticals, Inc | ANDA · DEA CIV |
| 68071-3770 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68071-2232 | Zolpidem Tartrate 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-2354 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-5120 | Zolpidem Tartrate 10 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-5093 | Zolpidem Tartrate 10 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-5063 | Zolpidem Tartrate 10 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 68071-4598 | Zolpidem Tartrate 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CIV |
| 72789-390 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 72789-323 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68788-8854 | Zolpidem Tartrate 5 mg/1 Tablet, Coated | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-8654 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-8376 | Zolpidem Tartrate 12.5 mg/1 Tablet, Film Coated, Extended Release | Preferred Pharmaceuticals Inc. | ANDA · DEA CIV |
| 68788-9127 | Zolpidem Tartrate 10 mg/1 Tablet | Preferred Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68788-9126 | Zolpidem Tartrate 5 mg/1 Tablet | Preferred Pharmaceuticals, Inc. | ANDA · DEA CIV |
| 68788-7422 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Preferred Pharmaceuticals, Inc.. | ANDA · DEA CIV |
| 63187-682 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 63187-691 | Zolpidem Tartrate 5 mg/1 Tablet, Coated | Proficient Rx LP | ANDA · DEA CIV |
| 63187-707 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA · DEA CIV |
| 63187-690 | Zolpidem Tartrate 10 mg/1 Tablet, Coated | Proficient Rx LP | ANDA · DEA CIV |
| 63187-114 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA · DEA CIV |
| 63187-558 | Zolpidem Tartrate 5 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 71205-286 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA · DEA CIV |
| 63187-565 | Zolpidem Tartrate 10 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CIV |
| 70518-2917 | Zolpidem Tartrate 5 mg/1 Tablet | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-3943 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA · DEA CIV |
| 70518-3739 | Zolpidem Tartrate 10 mg/1 Tablet, Coated | REMEDYREPACK INC. | ANDA · DEA CIV |
| 0781-5318 | Zolpidem Tartrate 10 mg/1 Tablet, Coated | Sandoz Inc | ANDA · DEA CIV |
| 0781-5317 | Zolpidem Tartrate 5 mg/1 Tablet, Coated | Sandoz Inc | ANDA · DEA CIV |
| 0781-5316 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | Sandoz Inc | ANDA · DEA CIV |
| 0781-5315 | Zolpidem Tartrate 6.25 mg/1 Tablet, Extended Release | Sandoz Inc | ANDA · DEA CIV |
| 60760-819 | Zolpidem Tartrate 12.5 mg/1 Tablet, Extended Release | St. Mary's Medical Park Pharmacy | ANDA · DEA CIV |
| 60760-761 | Zolpidem Tartrate 5 mg/1 Tablet, Coated | ST. MARY'S MEDICAL PARK PHARMACY | ANDA · DEA CIV |
| 60760-515 | Zolpidem Tartrate 5 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CIV |
| 60760-288 | Zolpidem Tartrate 10 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CIV |
| 47335-307 | Zolpidem Tartrate 6.25 mg/1 Tablet, Film Coated, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CIV |
| 47335-308 | Zolpidem Tartrate 12.5 mg/1 Tablet, Film Coated, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CIV |
| 72722-103 | Zolpidem Tartrate 5 mg/1 Tablet, Film Coated | The ACME Laboratories Ltd. | ANDA · DEA CIV |
| 72722-104 | Zolpidem Tartrate 10 mg/1 Tablet, Film Coated | The ACME Laboratories Ltd. | ANDA · DEA CIV |
| 13668-775 | Zolpidem Tartrate 7.5 mg/1 Capsule | TORRENT PHARMACEUTICALS LIMITED | ANDA · DEA CIV |
| 13668-008 | Zolpidem Tartrate 10 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA · DEA CIV |
| 13668-007 | Zolpidem Tartrate 5 mg/1 Tablet | Torrent Pharmaceuticals Limited | ANDA · DEA CIV |
| 60290-089 | Zolpidem Tartrate 7.5 mg/1 Capsule | Umedica Laboratories USA Inc. | ANDA · DEA CIV |
| 52427-775 | Zolpidem Tartrate 7.5 mg/1 Capsule | Almatica Pharma LLC | NDA · DEA CIV |
| 51407-762 | Zolpidem Tartrate 12.5 mg/1 Tablet, Coated | Golden State Medical Supply, Inc. | NDA · DEA CIV |
| 51407-761 | Zolpidem Tartrate 6.25 mg/1 Tablet, Coated | Golden State Medical Supply, Inc. | NDA · DEA CIV |
| 71610-770 | Zolpidem Tartrate 6.25 mg/1 Tablet, Film Coated, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC · DEA CIV |
| 63187-862 | Zolpidem Tartrate 12.5 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | NDA AUTHORIZED GENERIC · DEA CIV |
zolpidem tartrate recalls
- D-0271-2024 Jan 31, 2024 · Class II · Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. - D-0272-2024 Jan 31, 2024 · Class II · Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Frequently asked questions
What is zolpidem tartrate used for?
Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )] . Zolpidem Tartrate Capsules, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of transient…
What are the side effects of zolpidem tartrate?
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions ( 5.1 )] CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions ( 5.2 )] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions ( 5.4 )] Abnormal Thinking and Behavior Changes [see Warnings and… See the full label for the complete list.
Who makes zolpidem tartrate?
zolpidem tartrate is listed by 40 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC, American Health Packaging.
Has zolpidem tartrate been recalled?
The FDA enforcement database lists 2 recalls for zolpidem tartrate, most recently D-0271-2024 (class ii): CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.