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Does Intermezzo (zolpidem) cause side effects?
Benzodiazepines cause sedation, muscle relaxation, act as anticonvulsants (antiseizure medications), and reduce anxiety. Intermezzo has selectivity in that it has little of the muscle relaxant and antiseizure effects and more of the sedative effect. Therefore, it is used primarily as a medication for sleep.
Common side effects of Intermezzo include
Serious side effects of Intermezzo include
When abruptly discontinued, Intermezzo can cause abnormal behavior with confusion, paradoxical insomnia or "complex sleep-related behaviors," which may include sleep-driving (driving with no memory of having done so).
Intermezzo should not be combined with other sedative drugs because of the additive effects.
Itraconazole and ketoconazole may increase the blood concentration of Intermezzo by reducing the activity of the enzymes that break down Intermezzo in the liver. Conversely, rifampin may reduce the concentration of Intermezzo by increasing the activity of the enzymes that break down Intermezzo.
There are no adequate studies of Intermezzo use in pregnant women.
What are the important side effects of Intermezzo (zolpidem)?
The most common side effects of zolpidem are:
Other important side effects include:
When the drug is abruptly discontinued. Zolpidem can cause abnormal behavior with confusion, paradoxical insomnia or "complex sleep-related behaviors," which may include sleep-driving (driving with no memory of having done so). If these side effects occur, zolpidem should be discontinued. Zolpidem is a controlled substance because it is likely to be abused and may cause dependence.
Intermezzo (zolpidem) side effects list for healthcare professionals
The following serious adverse reactions in zolpidem-treated patients are discussed in greater detail in other sections of the labeling:
- CNS-depressant effects and next-day impairment
- Serious anaphylactic and anaphylactoid reactions
- Abnormal thinking and behavioral changes, and complex behaviors
- Withdrawal effects
Clinical Trials Experience
The safety data described below are based on two double-blind placebo-controlled trials of Intermezzo in adult patients with insomnia characterized by difficulty returning to sleep after a middle-of-the-night awakening.
- These two trials included 230 and 82 patients treated with 3.5 mg and 1.75 mg of Intermezzo, respectively.
- The first study was a 3way 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 Intermezzo 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 Intermezzo compared to placebo, used on an as-needed basis after spontaneous middle-of-the-night awakenings (Study 2).
- In Study 2, patients took Intermezzo 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 Intermezzo-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 Intermezzo in Table 1.
The most commonly reported adverse reactions in all treatment groups were
Table 1: Summary of Adverse Reactions ( ≥ 2%) in Outpatient, Double-Blind, Parallel-Group, Placebo-Controlled Study (Study 2)
|MedDRA System Organ Class|
|3.5 mg Intermezzo|
|General Disorders and Administration Site Conditions||3%||0%|
|Nervous System Disorders||5%||3%|
The following adverse reactions have been identified during post-approval use of Intermezzo. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.
- Application site reactions, primarily in the sublingual area, have been reported. These application site reactions included
- oral ulcers,
- blisters, and
- mucosal inflammation.
What drugs interact with Intermezzo (zolpidem)?
- Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression.
- Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.
- 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.
- 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.
- An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated.
- Concomitant administration of zolpidem and sertraline increases exposure to zolpidem and may increase the pharmacodynamic effect of zolpidem.
- After multiple doses of zolpidem tartrate and fluoxetine, an increase in the zolpidem half-life (17%) was observed.
- There was no evidence of an additive effect in psychomotor performance.
Drugs 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, 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, 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.
Does Intermezzo (zolpidem) cause addictional or withdrawal symptoms?
Drug Abuse And Dependence
- Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.
- 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 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
- 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 40 mg of oral zolpidem tartrate were similar, but not identical, to diazepam 20 mg, while 10 mg of oral zolpidem tartrate 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 Intermezzo.
- 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
- The following adverse events which are considered to meet the DSMIII-R criteria for uncomplicated sedative-hypnotic withdrawal were reported during U.S. clinical trials with other oral zolpidem formulations following placebo substitution occurring within 48 hours following the last zolpidem treatment:
- 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 resulting from use of oral zolpidem tartrate have been received.
Intermezzo (zolpidem) is a sedative/hypnotic used to treat insomnia in the middle of the night (awakening and experiencing difficulty returning to sleep). Common side effects of Intermezzo include headache, nausea, drowsiness, dizziness, and diarrhea. Intermezzo should not be combined with other sedative drugs because of the additive effects. There are no adequate studies of Intermezzo use in pregnant women. Intermezzo is excreted in human breast milk and may adversely affect the infant.
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Related Disease Conditions
What Are the Five Types of Insomnia?
The five types of insomnia are as follows: acute insomnia, chronic insomnia, onset insomnia, maintenance insomnia, and behavioral insomnia of childhood.
Second Source article from Government
Sleep: A Dynamic Activity
Second Source article from Government
Sleep Disorders (How to Get a Good Night's Sleep)
A number of vital tasks carried out during sleep help maintain good health and enable people to function at their best. Sleep needs vary from individual to individual and change throughout your life. The National Institutes of Health recommend about 7-9 hours of sleep each night for older, school-aged children, teens, and most average adults; 10-12 for preschool-aged children; and 16-18 hours for newborns. There are two stages of sleep; 1) REM sleep (rapid-eye movement), and 2) NREM sleep (non-rapid-eye movement). The side effects of lack of sleep or insomnia include: Irritability Tiredness Feeling sleepy during the day Concentration or memory problems Lack of sleep and insomnia can be caused by medical conditions or diseases, medications, stress, or pain. The treatment for lack of sleep and insomnia depends upon the cause.
What Causes Insomnia?
Insomnia is defined as repeated difficulty with sleep initiation, maintenance, consolidation, or quality that occurs despite adequate time and opportunity for sleep and results in some form of daytime impairment. There are three types of insomnia.
Insomnia is the perception or complaint of inadequate or poor-quality sleep because of difficulty falling asleep; waking up frequently during the night with difficulty returning to sleep; waking up too early in the morning; or unrefreshing sleep. Secondary insomnia is the most common type of insomnia. Treatment for insomnia include lifestyle changes, cognitive behavioral therapy, and medication.
Insomnia Treatment (Sleep Aids and Stimulants)
Insomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Insomnia is a symptom and not a disease. The most common causes of insomnia are medications, psychological conditions, environmental changes and stressful events. Treatments may include non-drug treatments, over-the-counter medicines, and/or prescription medications.
Why Am I Having Trouble Sleeping at Night?
Having repeated difficulty with sleep initiation, maintenance or poor quality of sleep that occurs despite adequate time and opportunity for sleep, resulting in some form of daytime impairment is called insomnia.
Sleep Disorders in Children and Teenagers
Sleep needs in children and teenagers depend on the age of the child. Sleep disorders in children such as: sleep apnea, parasomnias, confusional arousals, night terrors, nightmares, narcolepsy, and sleepwalking which can affect a child's or teen's sleep. Healthy sleep habits and good sleep hygiene can help your infant, toddler, preschooler, tween, or teenager get a good night's sleep.
Sleep Related Breathing Disorders
Sleep-related breathing disorders are characterized by disruptions of normal breathing patterns that only occur during sleep. Snoring and sleep apnea are the most common sleep-related breathing disorders.
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If you cannot fall asleep within 20-30 minutes of getting into bed or stay wide awake even after being extremely tired, then here are some tips.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects, drug interactions, and addiction sections courtesy of the U.S. Food and Drug Administration.