Zolpimist

Zolpimist contains zolpidem tartrate, a non-benzodiazepine hypnotic of the imidazopyridine class. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)tartrate (2:1). It has the following structure:

Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.89.

Zolpimist (zolpidem tartrate oral spray) is available as an oral solution designed to be sprayed directly into the mouth over the tongue. Each metered actuation of Zolpimist delivers 5 mg of zolpidem tartrate in 100 μL. Two actuations deliver 10 mg of zolpidem tartrate. Zolpimist (zolpidem tartrate oral spray) includes the following inactive ingredients: artificial cherry flavor, benzoic acid, citric acid monohydrate, hydrochloric acid, neotame, propylene glycol, and purified water.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Serious anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS].
• Abnormal thinking, behavior changes, and complex behaviors [see WARNINGS AND PRECAUTIONS].
• Withdrawal effects [see WARNINGS AND PRECAUTIONS].
• CNS-depressant effects [see WARNINGS AND PRECAUTIONS].

Clinical trials experience

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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating incidence rates.

Approximately 4% of 1,701 patients who received zolpidem tartrate at all doses (1.25 to 90 mg) 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 at all doses (1 to 50 mg) 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 revealed that four of the seven discontinuations during double-blind treatment with zolpidem (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.

During short-term treatment (up to 10 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).

The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

The following table was derived from results of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.

Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled Clinical Trials Lasting up to 10 Nights (Percentage of patients reporting)

The following table was derived from results of three placebo-controlled long-term efficacy trials involving zolpidem tartrate. These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem tartrate at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse reactions occurring at an incidence of at least 1% for zolpidem tartrate patients.

Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled Clinical Trials Lasting up to 35 Nights (Percentage of patients reporting)

There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem tartrate use, particularly for certain CNS and gastrointestinal adverse reactions.

The effect of chronic daily administrations of Zolpimist (zolpidem tartrate oral spray) on oral tissue has not been evaluated. In pharmacokinetic studies conducted with Zolpimist (zolpidem tartrate oral spray) in healthy subjects, an oral soft tissue exam was performed and no signs of oral irritation were noted following administration of single doses of Zolpimist (zolpidem tartrate oral spray) .

Zolpidem tartrate was administered to 3,660 subjects in clinical trials throughout the United States, Canada, and Europe. Treatment-emergent adverse event associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified WHO dictionary of preferred terms.

The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem tartrate, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem tartrate. All reported treatment-emergent adverse events are included, except those already listed in the table above of adverse events 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 events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.

Autonomic nervous system: Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.

Body as a whole: 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: 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: Frequent: ataxia, confusion, euphoria, headache, 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: 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, tendonitis.

Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain.

Respiratory system: Frequent: upper respiratory infection. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, epistaxis, hypoxia, laryngitis, pneumonia.

Skin and appendages: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.

Included as part of the PRECAUTIONS section.

Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking zolpidem, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Warning: Impairment from sleep drugs can be present despite feeling fully awake.

You may still feel drowsy the next day after taking Zolpimist. Do not drive or operate heavy machinery or take part in anything that requires alertness after taking Zolpimist until you are certain you are alert.

Serious side effects of Zolpimist may include:

• getting out of bed while not being fully awake and taking part in an activity that you do not know you are doing
• abnormal thoughts and behavior including:
  • more outgoing or aggressive behavior than normal
  • confusion 
  • agitation
  • hallucinations (seeing or hearing things that aren't there)
  • worsening of depression
  • suicidal thoughts or actions
• memory loss
• anxiety
• severe allergic reactions including:
• swelling of the tongue or throat
• trouble breathing
• nausea and vomiting

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Zolpimist.

The most common side effects of Zolpimist are:

• drowsiness
• dizziness
• diarrhea
• "drugged feelings"

Some people experience symptoms such as trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain after stopping sleep medicine. This may last 1-2 days. 

This is not a complete list of Zolpimist side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Do not take Zolpimist with other medicines that make you sleepy. Be sure to tell your doctor if you take:

• antidepressants such as imipramine (Tofranil) and sertraline (Zoloft)
• chlorpromazine (Thorazine)
• antifungal medicines such as itraconazole (Sporanox) and  ketoconazole (Nizoral)
• medications for anxiety
• cold medicines or allergy medicines
• medicines for mental illness
• pain medicines
• medicines for seizures
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• tranquilizers.

This is not a complete list of Zolpimist drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Zolpimist is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Zolpimist in a safe place to prevent misuse and abuse. Selling or giving away Zolpimist may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using zolpidem and call your doctor at once if you have:

• chest pain, fast or irregular heartbeat, feeling short of breath;

• trouble breathing or swallowing; or

• feeling like you might pass out.

Common side effects may include:

• daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;

• tired feeling, loss of coordination;

• stuffy nose, dry mouth, nose or throat irritation;

• nausea, constipation, diarrhea, upset stomach; or

• headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Clumsiness or unsteadiness
• confusion
• depression

• Difficulty with breathing
• dizziness, lightheadedness, or fainting
• falling
• fast heartbeat
• seeing, hearing, or feeling things that are not there
• skin rash
• swelling of the face
• trouble sleeping
• unusual excitement, nervousness, or irritability
• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Sleepiness or unusual drowsiness

• Abdominal or stomach pain
• abnormal or decreased touch sensation
• abnormal sensation of movement
• appetite disorder
• balance disorder
• binge eating
• bladder pain
• bloody or cloudy urine
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in hearing
• chest discomfort
• chills
• confusion about identity, place, and time
• constipation
• continuous ringing, buzzing, or other unexplained noise in the ears
• daytime drowsiness
• diarrhea
• difficult, burning, or painful urination
• difficulty with moving
• difficulty with swallowing
• discouragement
• double vision
• drugged feeling
• dry mouth
• earache
• eye redness
• false or unusual sense of well-being
• feeling of unreality
• feeling sad or empty
• frequent bowel movements
• frequent urge to urinate
• headache
• hearing loss
• heartburn
• hives or welts
• itching ears
• joint pain
• lack of appetite
• lack of feeling or emotion
• lack or loss of self-control
• lack or loss of strength
• longer or heavier menstrual periods
• loss of balance
• loss of interest or pleasure
• memory problems
• mood swings
• muscle aches, cramping, pain, or stiffness
• nausea
• nightmares or unusual dreams
• redness of the skin
• redness or soreness of the throat
• sense of detachment from self or body
• slowing of mental and physical activity
• sneezing
• stuffy or runny nose
• swollen joints
• tiredness
• trouble concentrating
• vision changes
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Controlled Substance

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

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 was difficult to distinguish from placebo.

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

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 reactions 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 reactions 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.

Postmarketing reports of abuse, dependence, and withdrawal have been received.

NDC 58407-0510-30

ZolpiMiST™
(zolpidem tartrate) ORAL SPRAY

5 mg
per spray

30 metered sprays

Net Contents: 4.5mL (4.8g)
Spray Volume: 0.1mL delivered per spray

CIV
Rx Only

MAGNA
Pharmaceuticals, Inc.

Manufactured for
MAGNA Pharmaceuticals, Inc.
Louisville, KY 40299

Some people using Zolpimist have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking Zolpimist and talk with your doctor about another treatment for your sleep disorder.

You should not use this medication if you are allergic to zolpidem.

To make sure Zolpimist is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);

• sleep apnea (breathing stops during sleep);

• myasthenia gravis;

• a history of depression, mental illness, or suicidal thoughts; or

• a history of drug or alcohol addiction.

Zolpimist may be habit forming and should be used only by the person it was prescribed for. Never share Zolpimist with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Zolpidem can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The sedative effects of Zolpimist may be stronger in older adults.

Do not give this medicine to anyone younger than 18 years of age.

Zolpimist may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Avoid taking Zolpimist during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Zolpimist.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Taking Zolpimist with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Zolpimist, especially:

• chlorpromazine;

• itraconazole or ketoconazole;

• rifampin; or

• an antidepressant - imipramine, sertraline.

Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Zolpimist. Give a list of all your medicines to any healthcare provider who treats you.

Applies to zolpidem: oral tablet, oral tablet extended release

Other dosage forms:

• spray, tablet

Along with its needed effects, zolpidem (the active ingredient contained in Zolpimist) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zolpidem:

• Chest pain
• confusion
• confusion about identity, place, and time
• discouragement
• false or unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling sad or empty
• fever
• general feeling of discomfort or illness
• irritability
• lack of appetite
• lightheadedness
• loss of interest or pleasure
• shakiness and unsteady walk
• tiredness
• trouble concentrating
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

• Anxiety
• bladder pain
• bloody or cloudy urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cold sweats
• crying
• decreased awareness or responsiveness
• depersonalization
• difficult, burning, or painful urination
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• dry mouth
• dysphoria
• euphoria
• fainting
• frequent urge to urinate
• hyperventilation
• irregular heartbeats
• irritability
• lower back or side pain
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• seeing, hearing, or feeling things that are not there
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• trembling or shaking of the hands or feet

• Attack, assault, or force
• black, tarry stools
• change in walking and balance
• clumsiness or unsteadiness
• cough
• delusions
• dementia
• difficulty swallowing
• dizziness
• hives, itching, or skin rash
• lack of feeling or emotion
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• thoughts of killing oneself or changes in behavior
• tightness in the chest
• troubled breathing with exertion
• uncaring
• unusual bleeding or bruising

Some side effects of zolpidem may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Drowsiness
• headache
• muscle aches
• sleepiness or unusual drowsiness
• stuffy or runny nose

• Abdominal or stomach discomfort
• acid or sour stomach
• back pain
• being forgetful
• belching
• body aches or pain
• congestion
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• double vision
• feeling of constant movement of self or surroundings
• heartburn
• hoarseness
• indigestion
• longer or heavier menstrual periods
• loss of memory
• muscle pain or stiffness
• nausea
• pain or tenderness around the eyes and cheekbones
• seeing double
• sensation of spinning
• tender, swollen glands in the neck
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• voice changes

• Bad, unusual, or unpleasant (after) taste
• breast pain
• change in taste
• changes in patterns and rhythms of speech
• increased sweating
• itching of the vagina or genital area
• pain during sexual intercourse
• paleness of the skin
• slurred speech
• thick, white vaginal discharge with no odor or with a mild odor
• vomiting

• Blemishes on the skin
• blindness
• blurred vision
• change in near or distance vision
• decreased interest in sexual intercourse
• difficulty in focusing eyes
• eye pain
• feeling of warmth
• frequent urge to defecate
• inability to have or keep an erection
• increased appetite
• increased sensitivity of the skin to sunlight
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• pimples
• redness of the face, neck, arms, and occasionally, upper chest
• redness or other discoloration of the skin
• severe sunburn
• stomach upset
• straining while passing stool
• tearing
• weight loss