Mirtazapine may increase the central nervous system depressant CNS depressant activities of Zolpidem. Perampanel may increase the central nervous system depressant CNS depressant activities of Zolpidem. Reactions including anaphylaxis or angioedema may occur with sedative-hypnotics, and may become evident as early as the initial dose. Insomnia is a symptom and not a disease. Ziprasidone may increase the central nervous system depressant CNS depressant activities of Zolpidem. How Do You Take Zolpidem?
Zolpidem can cause withdrawal symptoms muscle cramps, sweats, shaking, and seizures 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. What is the dosage for zolpidem? Which drugs or supplements interact with zolpidem?
Is zolpidem safe to take if I'm pregnant or breastfeeding? What else should I know about zolpidem? Zolpidem should be stored at room temperature, C F , in an air-tight container. Side effects, drug interactions , warnings and precautions, and pregnancy and breastfeeding safety information should be reviewed prior to taking any medication.
What is drug abuse? Learn about prescription drug abuse and over-the-counter OTC drugs, including depressants, pain relievers, Insomnia affects all age groups, and is the most common sleep disorder in the world. There also seems to be a link between Take our Sleeping Quiz to learn which sleep disorders, causes, and symptoms rule the night. Trouble falling or staying asleep? Learn about the different types of sleep disorders such as insomnia and sleep apnea.
Explore the symptoms, causes, tests and Are you an insomniac? Learn 10 tips on how to get a good night's sleep and avoid sleep disorders such as Some jobs can lead to sleep problems like insomnia, especially for graveyard and other shift work. Learn how work can disrupt Good sleep hygiene leads to better sleep. Avoid insomnia and sleep better by minimizing stress, exercising, and taking proper Post-traumatic stress disorder PTSD , a psychiatric condition, can develop after any catastrophic life event.
Sleepwalking is a condition in which an individual walks or does other activities while asleep. A number of vital tasks carried out during sleep help maintain good health and enable people to function at their best. Insomnia is the perception or complaint of inadequate or poor-quality sleep because of difficulty falling asleep; waking up Insomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep.
Travelers should prepare for their trip by visiting their physician to get the proper vaccinations and obtain the necessary You are encouraged to report negative side effects of prescription drugs to the FDA. People with insomnia often do not get enough sleep, and the sleep they do get is not refreshing. Learn causes, treatments, symptoms and types of insomnia. Hypnotics are sleep medications used to treat different types of insomnia.
There are a variety of hypnotic drugs, and they are grouped into five types. Benzodiazepines, nonbenzodiazepines, selective melatonin agonists these three drug types are classified as sedatives , antidepressants, and an orexin receptor agonist. Some hypnotics can be addictive and may cause withdrawal symptoms if discontinued abruptly. The side effects of hypnotics depend upon the drug used, but they may include: Diarrhea Cough Hair loss Dry skin Upset stomach Abnormal dreams Fatigue Hypnotics may have serious side effects and adverse effects, for example: Abnormal thinking Suicidal thinking Sleep paralysis Anemia Sleep driving and other complex behavior Exfoliate dermatitis Hypnotic drugs available over-the-counter OTC include diphenhydramine Benadryl and doxylamine Unisom.
Natural herbal supplements used for insomnia are melatonin and Valerian. Do not drink alcohol while taking hypnotic drugs. Stimulants like caffeine or amphetamines reduce the effect of insomnia medications. Your doctor or other health care professional will recommend the type of hypnotic drug for you depending upon the type of sleep problem you have, your current lifestyle habits, other medications you are taking, and any other medical problems you may have.
Sleep needs vary from individual to individual and change throughout your life. The National Institutes of Health recommend about hours of sleep each night for older, school-aged children, teens, and most average adults; for preschool-aged children; and hours for newborns. The side effects of lack of sleep or insomnia include:.
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. Insomnia, Sleep Apnea, and More Learn about the different types of sleep disorders such as insomnia and sleep apnea. Sleep Better, Conquer Insomnia What is insomnia?
Jobs That May Ruin Your Sleep Some jobs can lead to sleep problems like insomnia, especially for graveyard and other shift work. Posttraumatic Stress Disorder Post-traumatic stress disorder PTSD , a psychiatric condition, can develop after any catastrophic life event. Sleepwalking Causes, Symptoms, Treatment Sleepwalking is a condition in which an individual walks or does other activities while asleep. 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.
Insomnia Symptoms, Causes, Remedies, and Cures Insomnia is the perception or complaint of inadequate or poor-quality sleep because of difficulty falling asleep; waking up Insomnia Treatment Sleep Aids and Stimulants Insomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Travel Medicine Travelers should prepare for their trip by visiting their physician to get the proper vaccinations and obtain the necessary Health News Health Features.
Adults Takes a Psychiatric Drug: Study Desperate for Shut-Eye? Related Article Insomnia Quiz: Learn 10 tips on how to get a good night's sleep and avoid sleep disorders such as insomnia. Learn about prescription drug abuse and over-the-counter OTC drugs, including depressants, pain relievers, and stimulants. Drug interactions occur frequently. Get facts about the types of drug interactions, what substances or other things that may interact with drugs such as OTC drug and prescription drugs, vitamins, food s grapefruit , and laboratory tests.
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 tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Zolpidem tartrate tablets has no established use in labor and delivery [see Pregnancy 8. Zolpidem is excreted in human milk. Caution should be exercised when Zolpidem tartrate tablets is administered to a nursing woman. Zolpidem tartrate 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.
Ten patients on Zolpidem 7. A total of patients in U. For a pool of U. Women clear Zolpidem tartrate from the body at a lower rate than men. Given the higher blood levels of Zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of Zolpidem tartrate tablets for adult women is 5 mg, and the recommended dose for adult men is 5 or 10 mg. In geriatric patients, clearance of Zolpidem is similar in men and women.
The recommended dose of Zolpidem tartrate tablets in geriatric patients is 5 mg regardless of gender. 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 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: 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. 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.
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. 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. Zolpidem tartrate is a gamma-aminobutyric acid GABA A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.
It has the following structure:. Zolpidem tartrate is a white to almost white crystalline powder that is slightly soluble in water, sparingly soluble in methanol. It has a molecular weight of Each Zolpidem tartrate tablet includes the following inactive ingredients: 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. 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 tartrate at hypnotic doses.
In a single-dose crossover study in 45 healthy subjects administered 5 and 10 mg Zolpidem tartrate tablets, the mean peak concentrations C max were 59 range: The mean Zolpidem tartrate tablets elimination half-life was 2. Zolpidem tartrate tablet is converted to inactive metabolites that are eliminated primarily by renal excretion. Zolpidem tartrate tablets demonstrated linear kinetics in the dose range of 5 to 20 mg.
Total protein binding was found to be Zolpidem did not accumulate in young adults following nightly dosing with 20 mg Zolpidem tartrate tablets for 2 weeks. A food-effect study in 30 healthy male subjects compared the pharmacokinetics of Zolpidem tartrate tablets 10 mg when administered while fasting or 20 minutes after a meal. The half-life remained unchanged. These results suggest that, for faster sleep onset, Zolpidem tartrate tablets should not be administered with or immediately after a meal.
In the elderly, the dose for Zolpidem tartrate tablets should be 5 mg [see Warnings and Precautions 5 and Dosage and Administration 2 ]. Zolpidem tartrate tablets did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week. The pharmacokinetics of Zolpidem tartrate tablet in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects. Following a single 20 mg oral Zolpidem tartrate dose, mean C max and AUC were found to be two times vs.
T max did not change. The mean half-life in cirrhotic patients of 9. Dosing should be modified accordingly in patients with hepatic insufficiency [ see Dosage and Administration 2. No statistically significant differences were observed for C max , T max , half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. Zolpidem was not hemodialyzable.
No accumulation of unchanged drug appeared after 14 or 21 days. Zolpidem pharmacokinetics were not significantly different in renally impaired patients. No dosage adjustment is necessary in patients with compromised renal function. Similarly, chlorpromazine in combination with Zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.
The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration. Following five consecutive nightly doses at bedtime of oral Zolpidem tartrate 10 mg in the presence of sertraline 50 mg 17 consecutive daily doses, at 7: Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by Zolpidem. A single-dose interaction study with Zolpidem tartrate 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions.
There was no evidence of an additive effect in psychomotor performance. The effect of inhibitors of other P enzymes on the pharmacokinetics of Zolpidem is unknown. There were no pharmacodynamic effects of Zolpidem detected on subjective drowsiness, postural sway, or psychomotor performance. Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects.
In mice, these doses are approximately 2. No evidence of carcinogenic potential was observed in mice. In rats, renal tumors lipoma, liposarcoma were seen at the mid- and high doses. Zolpidem was negative in in vitro bacterial reverse mutation, mouse lymphoma, and chromosomal aberration and in vivo mouse micronucleus genetic toxicology assays. There was no impairment of fertility at any dose tested. Both Zolpidem doses were superior to placebo on objective polysomnographic measures of sleep latency, sleep duration, and number of awakenings.
All Zolpidem doses were superior to placebo on the two primary PSG parameters sleep latency and efficiency and all four subjective outcome measures sleep duration, sleep latency, number of awakenings, and sleep quality. On objective polysomnographic measures of sleep latency and sleep efficiency, Zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4.
Zolpidem was comparable to placebo on number of awakenings at both doses studied. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week. Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with Zolpidem tartrate tablets. Next-day residual effects of Zolpidem tartrate tablets were evaluated in seven studies involving normal subjects.
In three studies in adults including one study in a phase advance model of transient insomnia and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test DSST when compared to placebo. There was no objective polysomnographic evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of Zolpidem tartrate.
There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the recommended elderly dose of 5 mg. Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of Zolpidem tartrate tablets. However, in one study involving Zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect 90 minutes post-dose , i.
There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of Zolpidem tartrate tablets, predominantly at doses above 10 mg. Effects on sleep stages: In studies that measured the percentage of sleep time spent in each sleep stage, Zolpidem tartrate tablets has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 deep sleep was found comparable to placebo with only inconsistent, minor changes in REM paradoxical sleep at the recommended dose.
Zolpidem tartrate tablets 5 mg are pink, film coated, capsule shaped tablets, debossed with "W" on one side and plain on the other side:. Zolpidem tartrate tablets 10 mg are white, film coated, capsule shaped tablets, debossed with "W" on one side and plain on the other side:. Inform patients and their families about the benefits and risks of treatment with Zolpidem tartrate 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 tablets and with each prescription refill.
Review the Zolpidem tartrate tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that Zolpidem tartrate tablets should be taken only as prescribed. Tell patients that Zolpidem tartrate tablets have 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 8 hours after dosing before driving or engaging in other activities requiring full mental alertness.
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. 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. 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 tablets if they drank alcohol that evening or before bed. Tell patients not to increase the dose of Zolpidem tartrate tablets on their own, and to inform you if they believe the drug "does not work". Patients should be counseled to take Zolpidem tartrate tablets right before they get into bed and only when they are able to stay in bed a full night 7 to 8 hours before being active again.
Zolpidem tartrate tablets should not be taken with or immediately after a meal. Advise patients NOT to take Zolpidem tartrate tablets if they drank alcohol that evening. Read the Medication Guide that comes with Zolpidem tartrate 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 healthcare provider about your medical condition or treatment.
Call your healthcare provider right away if you find out that you have done any of the above activities after taking Zolpidem tartrate tablets. Zolpidem tartrate tablets are a sedative-hypnotic sleep medicine. Zolpidem tartrate tablets are used in adults for the short-term treatment of a sleep problem called insomnia trouble falling asleep. It is not known if Zolpidem tartrate tablets are safe and effective in children under the age of 18 years.
Symptoms of a serious allergic reaction to Zolpidem can include:.