ZOLPIDEM TARTRATE 1.75 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the gamma-Aminobutyric Acid A Receptor Positive Modulator class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Zolpidem is a prescription sleep medicine for insomnia. Depending on which form your doctor prescribed, it can help you fall asleep faster at bedtime, sleep through the night witho...
- What exactly is zolpidem supposed to do for me?
- This is one of the most important things to know: zolpidem can impair your driving and mental sharpness the next morning, even if you feel wide awake and fine. The risk goes up if...
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $5.56 | $166.67 / 30 tablet |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Zolpidem tartrate sublingual 1.75 mg 49884-0898-11 | Par | 30 tablets | $5.203 | AB | Availability likely | — |
| Zolpidem Tartrate 1.75 mgthis 43386-0762-30 | Lupin | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 43386-0762-30 You're viewing this | 30 POUCH in 1 CARTON (43386-762-30) / 1 BLISTER PACK in 1 POUCH (43386-762-01) / 1 TABLET in 1 BLISTER PACK | 2016-03-22 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 Sublingual Tablets. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Sublingual Tablets 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 box 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 Sublingual Tablets. Some of these events may result in serious injuries, including death.
Discontinue Zolpidem Tartrate Sublingual Tablets immediately if a patient experiences a complex sleep behavior (4, 5.1).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Zolpidem Tartrate is a GABA A agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep ( 1 ) Limitation of Use: Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking ( 1 ) Zolpidem Tartrate Sublingual Tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Limitations of Use : Zolpidem Tartrate Sublingual Tablet is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Take only if 4 hours of bedtime remain before the planned time of waking ( 2.1 , 5.1 ) Zolpidem Tartrate Sublingual Tablets should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. ( 2.1 ) The effect of Zolpidem Tartrate Sublingual Tablets may be slowed if taken with or immediately after a meal ( 2.1 ) Recommended dose is 1.75 mg for women and 3.5 mg for men, taken only once per night if needed ( 2.2 ) Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Sublingual Tablets ( 2.3 ) Co-administration with CNS depressants: Recommended dose is 1.75 mg for men and women ( 2.3 ) Geriatric patients and patients with hepatic impairment: Recommended dose is 1.75 mg for men and women ( 2.4 , 2.5 )
2.1Important Administration Instructions Zolpidem Tartrate Sublingual Tablet is to be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep. Zolpidem Tartrate Sublingual Tablet should only be taken if the patient has at least 4 hours of bedtime remaining before the planned time of waking [see Warnings and Precautions (5.1) ]. Zolpidem Tartrate Sublingual Tablet should be placed under the tongue and allowed to disintegrate completely before swallowing.
The tablet should not be swallowed whole. For optimal effect, Zolpidem Tartrate Sublingual Tablet should not be administered with or immediately after a meal. The blister should be removed from the pouch just prior to dosing.
2.2Basic Dosing Information The recommended and maximum dose of Zolpidem Tartrate Sublingual Tablet is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. The recommended doses for women and men are different because women clear zolpidem from the body at a lower rate than men [see Use in Specific Populations (8.6) ] .
2.3Use with CNS Depressants The recommended Zolpidem Tartrate Sublingual Tablet dose for men and women who are taking concomitant CNS depressants is 1.75 mg. Dose adjustment of concomitant CNS depressants may be necessary when co-administered with Zolpidem Tartrate Sublingual Tablet because of potentially additive effects. The use of Zolpidem Tartrate Sublingual Tablet with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Warnings and Precautions (5.1) ].
2.4Use in Geriatric Patients Geriatric patients may be especially sensitive to the effects of zolpidem. The recommended dose of Zolpidem Tartrate Sublingual Tablets in men and women over 65 years old is 1.75 mg, taken only once per night if needed [see Use in Specific Populations (8.5) ].
2.5Use in Patients with Hepatic Impairment The recommended dose of Zolpidem Tartrate Sublingual Tablet in patients with hepatic impairment is 1.75 mg, taken only once per night if needed [see Clinical Pharmacology (12.3) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 1.75 mg and 3.5 mg sublingual tablets ( 3 ) Zolpidem Tartrate Sublingual Tablets are available as 1.75 mg and 3.5 mg tablets for sublingual administration. Zolpidem Tartrate Sublingual Tablets 1.75 mg are white to off white, round, flat faced beveled edged tablets debossed with "N2"on one side and plain on the other side. Zolpidem Tartrate Sublingual Tablets 3.5 mg are white to off white, round, flat faced beveled edged tablets debossed with "NP"on one side and plain on the other side.
⛔ Contraindications ▾
4 CONTRAINDICATIONS Patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Sublingual Tablets (4, 5.1) Known hypersensitivity to zolpidem (4) Zolpidem Tartrate Sublingual Tablets are contraindicated in patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Sublingual Tablets [see Warnings and Precautions (5.1) ] Zolpidem Tartrate Sublingual Tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema [see Warnings and Precautions (5.3) ].
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS CNS depressant effects: Impairs alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Instruct patients on correct use (5.2) Evaluate for co-morbid diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use (5.2) Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported.
Do not re-challenge if such reactions occur (5.3) 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 number of tablets feasible to avoid intentional overdose (5.6) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function (5.7)
5.1COMPLEX 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. 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. Post-marketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [ see Drug Interactions (7.1)], .].
Discontinue Zolpidem Tartrate Sublingual Tablets immediately if a patient experiences a complex sleep behavior
5.2CNS Depressant Effects and Next-Day Impairment Zolpidem Tartrate Sublingual Tablets, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of Zolpidem Tartrate Sublingual Tablets and of other concomitant CNS depressants may be necessary when Zolpidem Tartrate Sublingual Tablets are administered with such agents because of the potentially additive effects.
The use of Zolpidem Tartrate Sublingual Tablets with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [ see Dosage and Administration (2.3) ] In a driving study, healthy subjects who received Zolpidem Tartrate Sublingual Tablets with fewer than four hours of bedtime remaining had evidence of impaired driving compared to subjects who received placebo [see Clinical Studies (14.2) ]. The risk of next-day driving impairment (and psychomotor impairment) is increased if Zolpidem Tartrate Sublingual Tablets is taken with less than 4 hours of bedtime remaining, if higher than recommended dose is taken, if co-administered with other CNS depressants, or co-administered with other drugs that increase the blood levels of zolpidem.
Because Zolpidem Tartrate Sublingual Tablets can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at a higher risk of falls.
5.3Need to Evaluate for Co-morbid 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 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…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most commonly observed adverse reactions (> 1% in adult patients) are headache, nausea, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch The following serious adverse reactions in zolpidem-treated patients 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)] Serious Anaphylactic and Anaphylactoid Reactions [ see Warnings and Precautions (5.2) ] Abnormal Thinking and Behavioral Changes [ see Warnings and Precautions (5.5) ] Withdrawal Effects [ see Warnings and Precautions (5.8) ]
6.1Clinical Trials Experience The safety data described below are based on two double-blind placebo-controlled trials of Zolpidem Tartrate Sublingual Tablets in adult patients with insomnia characterized by difficulty returning to sleep after a middle-of-the-night awakening [see Clinical Studies (14.1) ]. These two trials included 230 and 82 patients treated with 3.5 mg and 1.75 mg of Zolpidem Tartrate Sublingual Tablets, respectively. The first study was a 3-way crossover sleep-laboratory study in 82 patients (58 female and 24 male; median age 47 years; 51% Caucasian, 44% African-American) of 1.75 mg and 3.5 mg of Zolpidem Tartrate Sublingual Tablets compared to placebo (Study 1).
The second study was a 4-week, parallel-group at-home study in 295 patients (201 female and 94 male; median age 43 years) of 3.5 mg of Zolpidem Tartrate Sublingual Tablets compared to placebo, used on an as needed basis after spontaneous middle-of-the-night awakenings (Study 2). In Study 2, patients took Zolpidem Tartrate Sublingual Tablets during the night on 62% of study nights. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in actual practice.
Table 1 shows the incidence of adverse reactions reported in Study 2 that occurred in 2% or more of Zolpidem Tartrate Sublingual Tablet-treated (3.5 mg) patients in which the incidence was greater than the incidence in placebo-treated patients. For women and other patients taking the 1.75 mg dose in Study 1, the incidence of adverse reactions was similar to the incidence seen with 3.5 mg of Zolpidem Tartrate Sublingual Tablets in Table 1. The most commonly reported adverse reactions in all treatment groups were headache, nausea, and fatigue.
Table 1: Summary of Adverse Reactions (≥ 2%) in Outpatient, Double-Blind, Parallel-Group, Placebo-Controlled Study (Study 2) MedDRA System Organ Class Preferred Term 3 . 5 mg Zolpidem Tartrate Sublingual Tablets ( n = 150 ) Placebo ( n = 145 ) Gastrointestinal Disorders 4 % 2 % Nausea 1% 1% General Disorders and Administration Site Conditions 3 % 0 % Fatigue 1% 0% Nervous System Disorders 5 % 3 % Headache 3% 1%
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS depressant effects ( 5.1 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) Rifampin: Combination use may decrease effects ( 7.2 ) Ketoconazole: Combination use may increase effects ( 7.2 )
7.1CNS-active Drugs Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.2) ]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness.
Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. Haloperidol A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration.
Alcohol An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions (5.2) ]. Sertraline Concomitant administration of zolpidem and sertraline increases exposure to zolpidem and may increase the pharmacodynamic effect of zolpidem. Fluoxetine After multiple doses of zolpidem tartrate and fluoxetine, an increase in the zolpidem halflife (17%) was observed.
There was no evidence of an additive effect in psychomotor performance [see Clinical Pharmacology (12.3) ].
7.2Drugs that Affect Drug Metabolism via Cytochrome P450 Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of other P450 enzymes on the exposure to zolpidem is not known. Rifampin Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem.
Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem. Ketoconazole Ketoconazole, a potent CYP3A4 inhibitor, increased the pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, zolpidem may cause fetal harm. ( 8.1 ) Pediatric use: Safety and effectiveness of zolpidem not established. With bedtime dosing of zolpidem, hallucinations observed (incidence 7%) ( 8.4 )
8.1Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of zolpidem in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period.
Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. Zolpidem Tartrate Sublingual Tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring at doses greater than the recommended human dose (RHD) of 3.5 mg/day (approximately 2.8 mg/day zolpidem base); however, teratogenicity was not observed.
When zolpidem was administered at oral doses of 4, 20, and 100 mg base/kg/day to pregnant rats during the period of organogenesis, dose-related decreases in fetal skull ossification were observed at all but the lowest dose, which is approximately 15 times the RHD on a mg/m 2 basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and 16 mg base/kg/day, increased embryo-fetal death and incomplete fetal skull ossification were seen at the highest dose tested. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 30 times the RHD on a mg/m 2 basis.
Administration of zolpidem to rats at oral doses of 4, 20, and 100 mg base/kg/day during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately 15 times the RHD on a mg/m2 basis.
8.3Nursing Mothers Zolpidem is excreted in human milk. The effect of zolpidem on the nursing infant is not known.
8.4Pediatric Use Zolpidem Tartrate Sublingual Tablets are not recommended for use in children. Safety and effectiveness of Zolpidem Tartrate Sublingual Tablets have not been established in pediatric patients below the age of 18. In an 8-week study in pediatric patients (aged 6 to 17 years) with insomnia associated with ADHD, an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo.
Hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations.
8.5Geriatric Use Zolpidem Tartrate Sublingual Tablets dosage adjustment is necessary in geriatric patients. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Zolpidem Tartrate Sublingual Tablets and observed closely [see Dosage and Administration (2.4) , and Clinical Pharmacology (12.3) ]. Clinical trial experience with other zolpidem formulations (5 mg to 10 mg oral zolpidem tartrate) given at bedtime: A total of 154 patients in U.S.-controlled clinical trials and 897 patients in non-U.S. clinical trials who received oral zolpidem were ≥ 60 years of age.
For a pool of U.S. patients receiving oral zolpidem tartrate 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 (see Table 2). Falls in geriatric patients: A total of 30/1,959 (2%) non-U.S. patients receiving other zolpidem formulations (5 mg to 10 mg oral zolpidem tartrate) reported falls, including 28/30 (93%) who were ≥…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of zolpidem in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period.
Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. Zolpidem Tartrate Sublingual Tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring at doses greater than the recommended human dose (RHD) of 3.5 mg/day (approximately 2.8 mg/day zolpidem base); however, teratogenicity was not observed.
When zolpidem was administered at oral doses of 4, 20, and 100 mg base/kg/day to pregnant rats during the period of organogenesis, dose-related decreases in fetal skull ossification were observed at all but the lowest dose, which is approximately 15 times the RHD on a mg/m 2 basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and 16 mg base/kg/day, increased embryo-fetal death and incomplete fetal skull ossification were seen at the highest dose tested. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 30 times the RHD on a mg/m 2 basis.
Administration of zolpidem to rats at oral doses of 4, 20, and 100 mg base/kg/day during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately 15 times the RHD on a mg/m2 basis.
🧒 Pediatric Use ▾
8.4Pediatric Use Zolpidem Tartrate Sublingual Tablets are not recommended for use in children. Safety and effectiveness of Zolpidem Tartrate Sublingual Tablets have not been established in pediatric patients below the age of 18. In an 8-week study in pediatric patients (aged 6 to 17 years) with insomnia associated with ADHD, an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo.
Hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations.
🧓 Geriatric Use ▾
8.5Geriatric Use Zolpidem Tartrate Sublingual Tablets dosage adjustment is necessary in geriatric patients. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Zolpidem Tartrate Sublingual Tablets and observed closely [see Dosage and Administration (2.4) , and Clinical Pharmacology (12.3) ]. Clinical trial experience with other zolpidem formulations (5 mg to 10 mg oral zolpidem tartrate) given at bedtime: A total of 154 patients in U.S.-controlled clinical trials and 897 patients in non-U.S. clinical trials who received oral zolpidem were ≥ 60 years of age.
For a pool of U.S. patients receiving oral zolpidem tartrate 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 (see Table 2). Falls in geriatric patients: A total of 30/1,959 (2%) non-U.S. patients receiving other zolpidem formulations (5 mg to 10 mg oral zolpidem tartrate) reported falls, including 28/30 (93%) who were ≥ 70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem tartrate doses > 10 mg.
A total of 24/1,959 (1%) 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 tartrate doses >10 mg. The dose of Zolpidem Tartrate Sublingual Tablets in elderly patients is 1.75 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative-hypnotic drugs.
Table 2: Adverse Reactions in Geriatric Patients in Pooled Trials of 5 mg to 10 mg of Oral Zolpidem Tartrate Given at Bedtime Adverse Reaction 5 to 10 mg Oral Zolpidem Tartrate Placebo Dizziness 3% 0% Drowsiness 5% 2% Diarrhea 3% 1%
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Signs and Symptoms In post-marketing experience of overdose with oral 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.
10.2Recommended Treatment General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem's sedative-hypnotic effect was shown to be reduced by flumazenil and therefore flumazenil 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 treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem 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 is not dialyzable. As with management of all overdosage, the possibility of multiple drug ingestion should be considered. The healthcare provider may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which nonselectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ 1 receptor preferentially with a high affinity ratio of the alpha 1 /alpha 5 subunits.
This selective binding of zolpidem on the BZ 1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses.
12.3Pharmacokinetics Absorption Zolpidem Tartrate Sublingual Tablets disintegrates in the sublingual cavity after administration. On average, Zolpidem Tartrate Sublingual Tablets are rapidly absorbed in both genders, with a mean T max across studies of about 35 minutes to about 75 minutes. In healthy normal volunteers (age 21 to 45 years) dosed with 3.5 mg Zolpidem Tartrate Sublingual Tablets, the average C max and AUC were 77 ng/mL and 296 ng·h/mL, respectively in women.
The average C max and AUC were 53 ng/mL and 198 ng·h/mL, respectively in men. In women, the average C max and AUC of the 1.75 mg Zolpidem Tartrate Sublingual Tablets dose were 37 ng/mL and 151 ng·h/mL, respectively. Food decreased the overall C max and AUC of Zolpidem Tartrate Sublingual Tablets 3.5 mg by 42% and 19%, respectively, and increased the time to peak exposure (T max ) to nearly 3 hours.
For optimal effect, Zolpidem Tartrate Sublingual Tablets should not be administered with or immediately after a meal. Distribution Based on data obtained with oral zolpidem, the total protein binding was found to be 93% ± 0.1% and remained constant independent of concentration between 40 ng/mL and 790 ng/mL. Metabolism Based on data obtained with oral zolpidem, zolpidem tartrate is converted to inactive metabolites that are eliminated primarily by renal excretion.
Elimination The elimination half-life of a single dose of a 3.5 mg Zolpidem Tartrate Sublingual Tablet is approximately 2.5 hours (range 1.4 to 3.6 hours). Special Populations Elderly : The recommended dose for Zolpidem Tartrate Sublingual Tablets is 1.75 mg. A pharmacokinetic study of 1.75 mg and 3.5 mg doses of Zolpidem Tartrate Sublingual Tablets showed that the plasma C max and AUC 0-4hr in elderly subjects following the 3.5 mg dose was higher by 34% and 30%, respectively, than the non-elderly subjects.
The C max and AUC of 1.75 mg in elderly subjects were consistently lower than those observed for the 3.5 mg dose in non-elderly subjects but consistently higher than the 1.75 mg dose in non-elderly subjects. The elimination half-life remained unchanged. Hepatic Impairment : The pharmacokinetics of oral zolpidem tartrate in eight patients with chronic hepatic insufficiency were compared to results in subjects with normal hepatic function.
Following a single 20 mg oral zolpidem tartrate dose, mean C max and AUC were found to be two times (250 ng/mL vs. 499 ng/mL) and five times (788 ng·hr/mL vs. 4203 ng·hr/mL) higher, respectively, in hepatically compromised patients compared to subjects with normal hepatic function.
T max did not change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in subjects with normal hepatic function of 2.2 hr (range: 1.6 to 2.4 hr). Dosing should be modified accordingly in patients with hepatic insufficiency [see Dosage and Administration (2.5)].
Renal Impairment: The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage renal failure (mean Cl Cr = 6.5 ± 1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem tartrate 10 mg orally e…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which nonselectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ 1 receptor preferentially with a high affinity ratio of the alpha 1 /alpha 5 subunits.
This selective binding of zolpidem on the BZ 1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each Zolpidem Tartrate Sublingual Tablet is individually packaged in a blister inside a unit-dose pouch. Zolpidem Tartrate Sublingual Tablets 1.75 mg are white to off white, round, flat faced beveled edged debossed with "N2" on one side and plain on the other side and supplied as: NDC 43386-762-30: Carton of 30 unit-dose pouches Zolpidem Tartrate Sublingual Tablets 3.5 mg are white to off white, round, flat faced beveled edged debossed with "NP" on one side and plain on the other side and supplied as: NDC 43386-761-30: Carton of 30 unit-dose pouches Storage and Handling Store between 20°C to 25°C (68°F to 77°F), [see USP Controlled Room Temperature].
Protect from moisture. The patient should be instructed not to remove the blister from the unit-dose pouch until the patient is ready to consume the sublingual tablet inside. Do not use if blister seal is broken or missing.
📋 Description ▾
11 DESCRIPTION Zolpidem Tartrate Sublingual Tablets contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Zolpidem Tartrate Sublingual Tablets are available in 1.75 mg and 3.5 mg strength tablets for sublingual administration. Zolpidem Tartrate Sublingual Tablets are intended to be placed under the tongue where they will disintegrate.
Zolpidem Tartrate Sublingual Tablets contain a bicarbonate-carbonate buffer. Chemically, zolpidem tartrate is N,N -6-trimethyl-2- p -tolylimidazo[1,2- α ]pyridine-3-acetamide L-(+)-tartrate (2:1). Zolpidem tartrate is a white to almost white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol.
It has a molecular weight of 764.88. Each Zolpidem Tartrate Sublingual Tablet includes the following inactive ingredients: Crospovidone, Povidone, Mannitol, Polyvinylacetate, colloidal silicon dioxide, sodium carbonate anhydrous, sodium bicarbonate, natural and artificial spearmint flavor, aspartame, and magnesium stearate. Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with Zolpidem Tartrate Sublingual Tablets. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with Zolpidem Tartrate Sublingual Tablets and with each prescription refill.
Review the Zolpidem Tartrate Sublingual Tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that Zolpidem Tartrate Sublingual Tablets should be taken only as prescribed. Complex Sleep Behaviors Instruct patients and their families that Zolpidem Tartrate Sublingual Tablets 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 Sublingual Tablets 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 Tell patients that Zolpidem Tartrate Sublingual Tablets 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 4 hours after dosing and until they feel fully awake before driving or engaging in other activities requiring full mental alertness.
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. Suicide Tell patients to immediately report any suicidal thoughts.
Administration Instructions For detailed instructions on how to use Zolpidem Tartrate Sublingual Tablets, tell patients to refer to the Patient Instructions for Use. Tell patients that Zolpidem Tartrate Sublingual Tablets are to be taken only once per night if needed if they wake in the middle of the night and have difficulty returning to sleep. Tell patients that Zolpidem Tartrate Sublingual Tablets should only be taken if they have 4 hours of bedtime remaining before the planned time of waking.
Instruct the patient to place the tablet under the tongue, allowing it to disintegrate completely before swallowing. Tell the patient that Zolpidem Tartrate Sublingual Tablets should not be swallowed whole. Tell patients that the effect of Zolpidem Tartrate Sublingual Tablets may be slowed if taken with or immediately after a meal.
Instruct patients to remove the blister from the unit-dose pouch just prior to dosing. Advise patients NOT to take Zolpidem Tartrate Sublingual Tablets if they drank alcohol that day or before bed. Manufactured by: Novel Laboratories.
Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Rev.
12/2019 PI7610000205 SAP code: 263479
💬 Medication Guide ▾
MEDICATION GUIDE Zolpidem Tartrate ((zol' pi dem tar' trate)) Sublingual Tablet CIV Phenylketonurics Phenylalanine is a component of aspartame. Each 3.5 mg and 1.75 mg Zolpidem Tartarate Sublingual Tablets contains 4.48 mg and 2.24 mg of phenylalanine. Read the Medication Guide that comes with Zolpidem Tartrate Sublingual Tablets before you start taking it and each time you get a refill.
There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about Zolpidem Tartrate Sublingual Tablet?
Follow the Instructions for Use at the end of this Medication Guide when you take Zolpidem Tartrate Sublingual Tablet. If you do not follow the Instructions for Use, you might be drowsy in the morning without knowing it. Only take one Tablet a night, if needed.
Only take Zolpidem Tartrate Sublingual Tablet if you have at least 4 hours of bedtime left. Zolpidem Tartrate Sublingual Tablet may cause serious side effects, including: Complex sleep behaviors that have caused serious injury and death . After taking Zolpidem Tartrate Sublingual 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 (complex sleep behaviors).
The next morning, you may not remember that you did anything during the night. These activities may occur with Zolpidem Tartrate Sublingual Tablets whether or not you drink alcohol or take other medicines that make you sleepy Reported activities include: driving a car ("sleep-driving") making and eating food talking on the phone having sex sleep-walking Stop taking Zolpidem Tartrate Sublingual Tablet and call your healthcare provider right away if you find out that you have done any of the above activities after taking Zolpidem Tartrate Sublingual Tablet.
Important: Take Zolpidem Tartrate Sublingual Tablet exactly as prescribed Do not take Zolpidem Tartrate Sublingual Tablet if you: have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking Zolpidem Tartrate Sublingual Tablet drank alcohol that day or before bed. took another medicine to help you sleep. do not have at least 4 hours of bedtime remaining. What is Zolpidem Tartrate Sublingual Tablet? Zolpidem Tartrate Sublingual Tablet is a sedative-hypnotic (sleep) medicine.
Zolpidem Tartrate Sublingual Tablet is used in adults for the treatment of a sleep problem called insomnia. Many people have difficulty returning to sleep after awakening in the middle of the night. Zolpidem Tartrate Sublingual Tablet is designed to specifically treat this problem.
It is not known if Zolpidem Tartrate Sublingual Tablet is safe and effective in children. Zolpidem Tartrate Sublingual Tablet is a federally controlled substance (CIV) because it can be abused or lead to dependence. Keep Zolpidem Tartrate Sublingual Tablet in a safe place to prevent misuse and abuse.
Selling or giving away Zolpidem Tartrate Sublingual Tablet may harm others, and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines, or street drugs. Who should not take Zolpidem Tartrate Sublingual Tablet?
Do not take Zolpidem Tartrate Sublingual Tablets if you have ever had a complex sleep behavior happen after taking Zolpidem Tartrate Sublingual Tablets. Do not take Zolpidem Tartrate Sublingual Tablet if you are allergic to zolpidem or any other ingredients in Zolpidem Tartrate Sublingual Tablet. See the end of this Medication Guide for a complete list of ingredients in Zolpidem Tartrate Sublingual Tablet.
Do not take Zolpidem Tartrate Sublingual Tablet if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, Edluar, or Zolpimist. Symptoms of a serious allergic reaction to Zolpidem Tartrate Sublingual Tablet can include: swelling o…