2.1 Dosage in Adults

Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of Zolpidem Tartrate Extended-Release Tablets should not exceed 12.5 mg once daily immediately before bedtime. Zolpidem Tartrate Extended-Release Tablets should be taken as a single dose and should not be readministered during the same night.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

2.2 Special Populations

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of Zolpidem Tartrate Extended-Release Tablets in these patients is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.1), Use in Specific Populations (8.5)].

Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem Tartrate Extended-Release Tablets in these patients is 6.25 mg once daily immediately before bedtime. Avoid Zolpidem Tartrate Extended-Release Tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions (5.7), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.3 Use with CNS Depressants

Dosage adjustment may be necessary when Zolpidem Tartrate Extended-Release Tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

2.4 Administration

Zolpidem Tartrate Extended-Release Tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Zolpidem Tartrate Extended-Release Tablets may be slowed by ingestion with or immediately after a meal.

5.1 CNS Depressant Effects and Next-Day Impairment

Zolpidem Tartrate Extended-Release Tablets are a central nervous system (CNS) depressant and can impair daytime function in some patients even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of subjective symptoms, and may not be reliably detected by ordinary clinical exam (i.e. less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of Zolpidem Tartrate Extended-Release Tablets may develop, patients using Zolpidem Tartrate Extended-Release Tablets should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use.

Additive effects occur with concomitant use of other CNS depressants (e.g. benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of Zolpidem Tartrate Extended-Release Tablets and concomitant CNS depressants should be considered [see Dosage and Administration (2.3)].

The use of Zolpidem Tartrate Extended-Release Tablets with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

The risk of next-day psychomotor impairment is increased if Zolpidem Tartrate Extended-Release Tablets are taken with less than a full night of sleep remaining (7- to 8 hours); if higher than the recommended dose is taken; if co-administered with other CNS depressants or alcohol; or co-administered 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 Extended-Release Tablets is taken in these circumstances [see Dosage and Administration (2) and 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 (7–8 hours) is recommended.

5.2 Need 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 treatment with sedative/hypnotic drugs, including zolpidem.

5.3 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. 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 should not be rechallenged with the drug.

5.4 Abnormal Thinking and Behavioral Changes

Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including Zolpidem Tartrate Extended-Release Tablets. 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, <1% of adults with insomnia reported hallucinations. In a clinical trial, 7% of pediatric patients treated with zolpidem 0.25 mg/kg taken at bedtime reported hallucinations versus 0% treated with placebo [see Use in Specific Populations (8.4)].

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as "sleep-driving" have occurred with Zolpidem Tartrate Extended-Release Tablets alone at therapeutic doses, the co-administration of alcohol and other CNS depressants increases the risk of such behaviors, as does the use of Zolpidem Tartrate Extended-Release Tablets at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Zolpidem Tartrate Extended-Release Tablets should be strongly considered for patients who report a "sleep-driving" episode.

Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur.

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.

5.5 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 tablets that is feasible should be prescribed for the patient at any one time.

5.6 Respiratory Depression

Although studies with 10 mg zolpidem tartrate 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 compared to placebo. Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if Zolpidem Tartrate Extended-Release Tablets are prescribed to patients with compromised respiratory function. Post-marketing reports of respiratory insufficiency in patients receiving 10 mg of zolpidem tartrate, most of whom had pre-existing respiratory impairment, have been reported. The risk of respiratory depression should be considered prior to prescribing Zolpidem Tartrate Extended-Release Tablets in patients with respiratory impairment including sleep apnea and myasthenia gravis.

5.7 Precipitation of Hepatic Encephalopathy

GABA agonists 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 Extended-Release Tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration (2.2), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

5.8 Withdrawal Effects

There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence [see Drug Abuse and Dependence (9.2) and (9.3)].

5.9 Severe Injuries

Zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries. Severe injuries such as hip fractures and intracranial hemorrhage have been reported.

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Zolpidem Tartrate Extended-Release Tablets. 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).

7.1 CNS-active Drugs

Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability [see Warnings and Precautions (5.1)]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.

7.2 Drugs that Affect Drug Metabolism via Cytochrome P450

Some compounds known to induce or inhibit CYP3A may affect exposure to zolpidem. The effect of drugs that induce or inhibit other P450 enzymes on the exposure to zolpidem is not known.

8.1 Pregnancy

8.2 Labor and Delivery

Zolpidem Tartrate Extended-Release Tablets have no established use in labor and delivery [see Pregnancy (8.1)].

8.3 Nursing Mothers

Zolpidem is excreted in human milk. Caution should be exercised when Zolpidem Tartrate Extended-Release Tablets are administered to a nursing woman.

8.4 Pediatric Use

Zolpidem Tartrate Extended-Release Tablets are not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established.

In an 8-week study in pediatric patients (aged 6–17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. Psychiatric and nervous system disorders comprised the most frequent (> 5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Warnings and Precautions (5.4)]. Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction.

FDA has not required pediatric studies of Zolpidem Tartrate Extended-Release Tablets in the pediatric population based on these efficacy and safety findings.

8.5 Geriatric Use

A total of 99 elderly (≥ 65 years of age) received daily doses of 6.25 mg Zolpidem Tartrate Extended-Release Tablets in a 3-week placebo-controlled study. The adverse reaction profile of Zolpidem Tartrate Extended-Release Tablets 6.25 mg in this population was similar to that of Zolpidem Tartrate Extended-Release Tablets 12.5 mg in younger adults (≤ 64 years of age). Dizziness was reported in 8% of Zolpidem Tartrate Extended-Release Tablets-treated patients compared with 3% of those treated with placebo.

The dose of Zolpidem Tartrate Extended-Release Tablets in elderly patients is 6.25 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Warnings and Precautions (5.1)].

8.6 Gender Difference in Pharmacokinetics

Women clear zolpidem tartrate from the body at a lower rate than men. Cmax and AUC parameters of zolpidem from Zolpidem Tartrate Extended-Release Tablets were, respectively, approximately 50% and 75% higher at the same dose in adult female subjects compared to adult male subjects. Between 6 and 12 hours after dosing, zolpidem concentrations were 2- to 3 fold higher in adult female compared to adult male subjects. Given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of Zolpidem Tartrate Extended-Release Tablets for adult women is 6.25 mg, and the recommended dose for adult men is 6.25 or 12.5 mg.

In geriatric patients, clearance of zolpidem is similar in men and women. The recommended dose of Zolpidem Tartrate Extended-Release Tablets in geriatric patients is 6.25 mg regardless of gender.

8.7 Hepatic Impairment

The recommended dose of Zolpidem Tartrate Extended-Release Tablets in patients with mild to moderate hepatic impairment is 6.25 mg once daily immediately before bedtime. Avoid Zolpidem Tartrate Extended-Release Tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration (2.2), Warnings and Precautions (5.7), Clinical Pharmacology (12.3)].

9.1 Controlled Substance

Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.

9.2 Abuse

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common.

Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg effects were difficult to distinguish from placebo.

Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic.

9.3 Dependence

Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.

Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. The following adverse events, which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal, were reported during U.S. clinical trials following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received.

10.1 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.

10.2 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'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 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 the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

12.1 Mechanism 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 receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits. This selective binding of zolpidem on the BZ1 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 tartrate at hypnotic doses.

12.3 Pharmacokinetics

Zolpidem Tartrate Extended-Release Tablets exhibit biphasic absorption characteristics, which results in rapid initial absorption from the gastrointestinal tract similar to zolpidem tartrate immediate-release, then provides extended plasma concentrations beyond three hours after administration. A study in 24 healthy male subjects was conducted to compare mean zolpidem plasma concentration-time profiles obtained after single oral administration of Zolpidem Tartrate Extended-Release Tablets 12.5 mg and of an immediate-release formulation of zolpidem tartrate (10 mg). The terminal elimination half-life observed with Zolpidem Tartrate Extended-Release Tablets (12.5 mg) was similar to that obtained with immediate-release zolpidem tartrate (10 mg). The mean plasma concentration-time profiles are shown in Figure 1.

Figure 1: Mean plasma concentration-time profiles for Zolpidem Tartrate Extended-Release Tablets (12.5 mg) and immediate-release zolpidem tartrate (10 mg)

In adult and elderly patients treated with Zolpidem Tartrate Extended-Release Tablets, there was no evidence of accumulation after repeated once-daily dosing for up to two weeks.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14.1 Controlled Clinical Trials

Zolpidem Tartrate Extended-Release Tablets were evaluated in three placebo-controlled studies for the treatment of patients with chronic primary insomnia (as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM IV).

Adult outpatients (18–64 years) with primary insomnia (N=212) were evaluated in a double-blind, randomized, parallel-group, 3-week trial comparing Zolpidem Tartrate Extended-Release Tablets 12.5 mg and placebo. Zolpidem Tartrate Extended-Release Tablets 12.5 mg decreased wake time after sleep onset (WASO) for the first 7 hours during the first 2 nights and for the first 5 hours after 2 weeks of treatment. Zolpidem Tartrate Extended-Release Tablets 12.5 mg were superior to placebo on objective measures (polysomnography recordings) of sleep induction (by decreasing latency to persistent sleep [LPS]) during the first 2 nights of treatment and after 2 weeks of treatment. Zolpidem Tartrate Extended-Release Tablets 12.5 mg were also superior to placebo on the patient reported global impression regarding the aid to sleep after the first 2 nights and after 3 weeks of treatment.

Elderly outpatients (≥ 65 years) with primary insomnia (N=205) were evaluated in a double-blind, randomized, parallel-group, 3-week trial comparing Zolpidem Tartrate Extended-Release Tablets 6.25 mg and placebo. Zolpidem Tartrate Extended-Release Tablets 6.25 mg decreased wake time after sleep onset (WASO) for the first 6 hours during the first 2 nights and the first 4 hours after 2 weeks of treatment. Zolpidem Tartrate Extended-Release Tablets 6.25 mg were superior to placebo on objective measures (polysomnography recordings) of sleep induction (by decreasing LPS) during the first 2 nights of treatment and after 2 weeks on treatment. Zolpidem Tartrate Extended-Release Tablets 6.25 mg were superior to placebo on the patient reported global impression regarding the aid to sleep after the first 2 nights and after 3 weeks of treatment.

In both studies, in patients treated with Zolpidem Tartrate Extended-Release Tablets, polysomnography showed increased wakefulness at the end of the night compared to placebo-treated patients.

In a 24-week double-blind, placebo controlled, randomized study in adult outpatients (18–64 years) with primary insomnia (N=1025), Zolpidem Tartrate Extended-Release Tablets 12.5 mg administered as needed (3 to 7 nights per week) was superior to placebo over 24 weeks, on patient global impression regarding aid to sleep, and on patient-reported specific sleep parameters for sleep induction and sleep maintenance with no significant increased frequency of drug intake observed over time.

14.2 Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs

Store between 15°–25° C (59°–77°F). Limited excursions permissible up to 30° C (86°F)

CNS Depressant Effects and Next-Day Impairment

Tell patients that Zolpidem Tartrate Extended-Release Tablets can cause next-day impairment even when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed. Caution patients against driving and other activities requiring complete mental alertness the day after use. Inform patients that impairment can be present despite feeling fully awake.

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.

Sleep-driving and Other Complex Behaviors

Instruct patients and their families that sedative hypnotics can cause abnormal thinking and behavior change, including "sleep driving" and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients to call you immediately if they develop any of these symptoms.

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 Extended-Release Tablets if they drank alcohol that evening or before bed.

Tolerance, Abuse, and Dependence

Tell patients not to increase the dose of Zolpidem Tartrate Extended-Release Tablets 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 right before they get into bed and only when they are able to stay in bed a full night (7–8 hours) before being active again. Zolpidem Tartrate Extended-Release Tablets should not be taken with or immediately after a meal. Advise patients NOT to take Zolpidem Tartrate Extended-Release Tablets if they drank alcohol that evening.

Who should not take ZOLPIDEM TARTRATE Extended-Release Tablets?

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Do not take ZOLPIDEM TARTRATE Extended-Release Tablets if you are allergic to zolpidem or any other ingredients in ZOLPIDEM TARTRATE Extended-Release Tablets. See the end of this Medication Guide for a complete list of ingredients in ZOLPIDEM TARTRATE Extended-Release Tablets.

•

Do not take ZOLPIDEM TARTRATE Extended-Release Tablets if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Edluar, Zolpimist, or Intermezzo.

 

Symptoms of a serious allergic reaction to zolpidem can include:

1.

swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

What should I tell my healthcare provider before taking ZOLPIDEM TARTRATE Extended-Release Tablets?

ZOLPIDEM TARTRATE Extended-Release Tablets may not be right for you. Before starting ZOLPIDEM TARTRATE Extended-Release Tablets, tell your healthcare provider about all of your health conditions, including if you:

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have a history of depression, mental illness, or suicidal thoughts

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have a history of drug or alcohol abuse or addiction

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have kidney or liver disease

•

have a lung disease or breathing problems

•

are pregnant, planning to become pregnant. It is not known if ZOLPIDEM TARTRATE Extended-Release Tablets will harm your unborn baby.

•

are breastfeeding or plan to breastfeed. ZOLPIDEM TARTRATE Extended-Release Tablets can pass into your breast milk. It is not known if ZOLPIDEM TARTRATE Extended-Release Tablets will harm your baby. Talk to your healthcare provider about the best way to feed your baby while you take ZOLPIDEM TARTRATE Extended-Release Tablets.

Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Medicines can interact with each other, sometimes causing serious side effects. Do not take ZOLPIDEM TARTRATE Extended-Release Tablets with other medicines that can make you sleepy unless your healthcare provider tells you to.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take ZOLPIDEM TARTRATE Extended-Release Tablets?

•

See "What is the most important information I should know about ZOLPIDEM TARTRATE Extended-Release Tablets?"

•

Take ZOLPIDEM TARTRATE Extended-Release Tablets exactly as prescribed. Only take 1 ZOLPIDEM TARTRATE Extended-Release tablet a night if needed.

•

Do not take ZOLPIDEM TARTRATE Extended-Release Tablets if you drank alcohol that evening or before bed.

•

You should not take ZOLPIDEM TARTRATE Extended-Release Tablets with or right after a meal. ZOLPIDEM TARTRATE Extended-Release Tablets may help you fall asleep faster if you take it on an empty stomach.

•

Take ZOLPIDEM TARTRATE Extended-Release Tablets whole. Do not break, crush, dissolve or chew ZOLPIDEM TARTRATE Extended-Release Tablets before swallowing. If you cannot swallow ZOLPIDEM TARTRATE Extended-Release Tablets whole, tell your healthcare provider. You may need a different medicine.

•

Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.

•

If you take too much ZOLPIDEM TARTRATE Extended-Release Tablets or overdose, get emergency treatment.

What are the possible side effects of ZOLPIDEM TARTRATE Extended-Release Tablets?

ZOLPIDEM TARTRATE Extended-Release Tablets may cause serious side effects including:

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getting out of bed while not being fully awake and doing an activity that you do not know you are doing. (See "What is the most important information I should know about ZOLPIDEM TARTRATE Extended-Release Tablets?")

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abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.

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memory loss

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anxiety

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severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking ZOLPIDEM TARTRATE Extended-Release Tablets.

•

falls, which may lead to severe injuries

Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using ZOLPIDEM TARTRATE Extended-Release Tablets.

The most common side effects of ZOLPIDEM TARTRATE Extended-Release Tablets are:

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headache

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sleepiness

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dizziness

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drowsiness the next day after you take a ZOLPIDEM TARTRATE Extended-Release tablet

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:

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trouble sleeping

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nausea

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flushing

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lightheadedness

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uncontrolled crying

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vomiting

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stomach cramps

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panic attack

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nervousness

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stomach area pain

These are not all the side effects of ZOLPIDEM TARTRATE Extended-Release Tablets. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.

How should I store ZOLPIDEM TARTRATE Extended-Release Tablets?

Store ZOLPIDEM TARTRATE Extended-Release Tablets at room temperature, 59°F to 77°F (15°C to 25°C).

Keep ZOLPIDEM TARTRATE Extended-Release Tablets and all medicines out of reach of children.

General Information about the safe and effective use of ZOLPIDEM TARTRATE Extended-Release Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use ZOLPIDEM TARTRATE Extended-Release Tablets for a condition for which it was not prescribed. Do not share ZOLPIDEM TARTRATE Extended-Release Tablets with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about ZOLPIDEM TARTRATE Extended-Release Tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ZOLPIDEM TARTRATE Extended-Release Tablets that is written for healthcare professionals.

For more information, call 1-800-633-1610.

What are the ingredients in ZOLPIDEM TARTRATE Extended-Release Tablets?

Active Ingredient: Zolpidem tartrate

Inactive Ingredients:

The 6.25 mg tablets contain: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide.

The 12.5 mg tablets contain: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.