Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 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].; PRINCIPAL DISPLAY PANEL - Bottle Label NDC 52427- 775 -30 Zolpidem Tartrate Capsules CIV 7.5 mg ATTENTION PHARMACIST: Each patient is required to receive the accompanying Medication Guide. Contains FD&C Yellow No. 6 Rx only For oral use 30 Capsules label
- 16 HOW SUPPLIED/STORAGE AND HANDLING 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].
- PRINCIPAL DISPLAY PANEL - Bottle Label NDC 52427- 775 -30 Zolpidem Tartrate Capsules CIV 7.5 mg ATTENTION PHARMACIST: Each patient is required to receive the accompanying Medication Guide. Contains FD&C Yellow No. 6 Rx only For oral use 30 Capsules label
Overview
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
Indications & Usage
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 & 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.
Warnings & 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. Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported. In controlled trials of zolpidem tartrate immediate-release 10 mg taken at bedtime <1% of adults with insomnia reported hallucinations. In a clinical trial, 7% of pediatric patients treated with zolpidem tartrate immediate-release 0.25 mg/kg taken at bedtime reported hallucinations versus 0% treated with placebo (Zolpidem Tartrate Capsules are not approved for use in pediatric patients) [see Use in Specific Populations ( 8.4 )] . There have been postmarketing reports of delirium with zolpidem tartrate use [see Adverse Reactions ( 6.2 )] . It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. 5.6 Use in Patients with Depression In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the lowest number of Zolpidem Tartrate Capsules that is feasible should be prescribed for the patient at any one time. 5.7 Respiratory Depression Although studies with 10 mg zolpidem tartrate immediate-release did not reveal respiratory depressant effects at hypnotic doses in healthy subjects or in patients with mild to moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index, together with a reduction in lowest oxygen saturation and increase in the times of oxygen desaturation below 80% and 90%, was observed in patients with mild to moderate sleep apnea when treated with zolpidem tartrate immediate-release compared to placebo. Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if Zolpidem Tartrate Capsules are prescribed to patients with compromised respiratory function or concomitant use with opioids or other CNS depressants. Postmarketing reports of respiratory insufficiency in patients receiving 10 mg of zolpidem tartrate immediate-release, most of whom had pre-existing respiratory impairment, have been reported. The risk of respiratory depression should be considered prior to prescribing Zolpidem Tartrate Capsules in patients with respiratory impairment including sleep apnea and myasthenia gravis or with concomitant opioid use [see Dosage and Administration ( 2.5 ), Drug Interactions ( 7 )] . 5.8 Precipitation of Hepatic Encephalopathy Drugs affecting GABA receptors, such as zolpidem tartrate, have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency. In addition, patients with hepatic insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function. Avoid Zolpidem Tartrate Capsules use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration ( 2.1 ), Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] . 5.9 Withdrawal Effects There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem tartrate. Monitor patients for tolerance, abuse, and dependence [see Drug Abuse and Dependence ( 9.2 , 9.3 )] .
Boxed Warning
COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Capsules. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Capsules immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. 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 Tartrate Capsules. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Capsules immediately if a patient experiences a complex sleep behavior. ( 4 , 5.1 )
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 )
Adverse Reactions
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. Infrequent: edema, falling, fatigue, fever, malaise, trauma. Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease. Cardiovascular system: palpitation; Infrequent: cerebrovascular disorder, hypertension, tachycardia. Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia. Central and peripheral nervous system: abnormal dreams, amnesia, depression, drugged feeling, lethargy, lightheadedness, sleep disorder; Frequent: ataxia, confusion, euphoria, insomnia, vertigo. Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts, tetany, yawning. Gastrointestinal system: abdominal pain; Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries. Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis. Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media. Liver and biliary system: Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia, increased SGOT. Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema. Musculoskeletal system: Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendinitis. Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain. Respiratory system: pharyngitis, sinusitis; Frequent: upper respiratory infection, lower respiratory infection. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia. Skin and appendages: rash; Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria. Special senses: Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia. Urogenital system: Frequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of zolpidem tartrate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Liver and biliary system: acute hepatocellular, cholestatic or mixed liver injury with or without jaundice (i.e., bilirubin >2 × ULN, alkaline phosphatase ≥2 × ULN, transaminase ≥5 × ULN). Psychiatric disorders: delirium
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 )
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