Zaleplon 10 mg capsule

Sonata

CLINICAL PHARMACOLOGY

Pharmacodynamics And Mechanism Of Action

While Sonata (zaleplon) is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with the gamma-aminobutyric acid-benzodiazepine (GABA-BZ) receptor complex. Subunit modulation of the GABA-BZ receptor chloride channel macromolecular complex is hypothesized to be responsible for some of the pharmacological properties of benzodiazepines, which include sedative, anxiolytic, muscle relaxant, and anticonvulsive effects in animal models.

Other nonclinical studies have also shown that zaleplon binds selectively to the brain omega-1 receptor situated on the alpha subunit of the GABAA/chloride ion channel receptor complex and potentiates t-butyl-bicyclophosphorothionate (TBPS) binding. Studies of binding of zaleplon to recombinant GABAA receptors (α1β1γ2 and α2β1γ2 ) have shown that zaleplon has a low affinity for these receptors, with preferential binding to the omega-1 receptor.

Pharmacokinetics

The pharmacokinetics of zaleplon have been investigated in more than 500 healthy subjects (young and elderly), nursing mothers, and patients with hepatic disease or renal disease. In healthy subjects, the pharmacokinetic profile has been examined after single doses of up to 60 mg and once-daily administration at 15 mg and 30 mg for 10 days. Zaleplon was rapidly absorbed with a time to peak concentration (tmax) of approximately 1 hour and a terminal-phase elimination half-life (t½) of approximately 1 hour. Zaleplon does not accumulate with once-daily administration and its pharmacokinetics are dose proportional in the therapeutic range.

Absorption

Zaleplon is rapidly and almost completely absorbed following oral administration. Peak plasma concentrations are attained within approximately 1 hour after oral administration. Although zaleplon is well absorbed, its absolute bioavailability is approximately 30% because it undergoes significant presystemic metabolism.

Distribution

Zaleplon is a lipophilic compound with a volume of distribution of approximately 1.4 L/kg following intravenous (IV) administration, indicating substantial distribution into extravascular tissues. The in vitro plasma protein binding is approximately 60%±15% and is independent of zaleplon concentration over the range of 10 ng/mL to 1000 ng/mL. This suggests that zaleplon disposition should not be sensitive to alterations in protein binding. The blood to plasma ratio for zaleplon is approximately 1, indicating that zaleplon is uniformly distributed throughout the blood with no extensive distribution into red blood cells.

Metabolism

After oral administration, zaleplon is extensively metabolized, with less than 1% of the dose excreted unchanged in urine. Zaleplon is primarily metabolized by aldehyde oxidase to form 5-oxo-zaleplon. Zaleplon is metabolized to a lesser extent by cytochrome P450 (CYP) 3A4 to form desethylzaleplon, which is quickly converted, presumably by aldehyde oxidase, to 5-oxo-desethylzaleplon. These oxidative metabolites are then converted to glucuronides and eliminated in urine. All of zaleplon’s metabolites are pharmacologically inactive.

Elimination

After either oral or IV administration, zaleplon is rapidly eliminated with a mean t½ of approximately 1 hour. The oral-dose plasma clearance of zaleplon is about 3 L/h/kg and the IV zaleplon plasma clearance is approximately 1 L/h/kg. Assuming normal hepatic blood flow and negligible renal clearance of zaleplon, the estimated hepatic extraction ratio of zaleplon is approximately 0.7, indicating that zaleplon is subject to high first-pass metabolism.

After administration of a radiolabeled dose of zaleplon, 70% of the administered dose is recovered in urine within 48 hours (71% recovered within 6 days), almost all as zaleplon metabolites and their glucuronides. An additional 17% is recovered in feces within 6 days, most as 5-oxo-zaleplon.

Effect Of Food

In healthy adults a high-fat/heavy meal prolonged the absorption of zaleplon compared to the fasted state, delaying tmax by approximately 2 hours and reducing Cmax by approximately 35%. Zaleplon AUC and elimination half-life were not significantly affected. These results suggest that the effects of Sonata on sleep onset may be reduced if it is taken with or immediately after a high-fat/heavy meal.

Special Populations

Age

The pharmacokinetics of Sonata (zaleplon) have been investigated in three studies with elderly men and women ranging in age from 65 to 85 years. The pharmacokinetics of Sonata in elderly subjects, including those over 75 years of age, are not significantly different from those in young healthy subjects.

Gender

There is no significant difference in the pharmacokinetics of Sonata in men and women.

Race

The pharmacokinetics of zaleplon have been studied in Japanese subjects as representative of Asian populations. For this group, Cmax and AUC were increased 37% and 64%, respectively. This finding can likely be attributed to differences in body weight, or alternatively, may represent differences in enzyme activities resulting from differences in diet, environment, or other factors. The effects of race on pharmacokinetic characteristics in other ethnic groups have not been well characterized.

Hepatic Impairment

Zaleplon is metabolized primarily by the liver and undergoes significant presystemic metabolism. Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up to 4-fold and 7-fold in compensated and decompensated patients, respectively), in comparison with healthy subjects. The dose of Sonata should therefore be reduced in patients with mild to moderate hepatic impairment (see DOSAGE AND ADMINISTRATION). Sonata is not recommended for use in patients with severe hepatic impairment.

Renal Impairment

Because renal excretion of unchanged zaleplon accounts for less than 1% of the administered dose, the pharmacokinetics of zaleplon are not altered in patients with renal insufficiency. No dose adjustment is necessary in patients with mild to moderate renal impairment. Sonata has not been adequately studied in patients with severe renal impairment.

Drug-Drug Interactions

Because zaleplon is primarily metabolized by aldehyde oxidase, and to a lesser extent by CYP3A4, inhibitors of these enzymes might be expected to decrease zaleplon’s clearance and inducers of these enzymes might be expected to increase its clearance. Zaleplon has been shown to have minimal effects on the kinetics of warfarin (both R- and S- forms), imipramine, ethanol, ibuprofen, diphenhydramine, thioridazine, and digoxin. However, the effects of zaleplon on inhibition of enzymes involved in the metabolism of other drugs have not been studied. (See DRUG INTERACTIONS under PRECAUTIONS.)

Clinical Trials

Controlled Trials Supporting Effectiveness

Sonata (typically administered in doses of 5 mg, 10 mg, or 20 mg) has been studied in patients with chronic insomnia (n = 3,435) in 12 placebo- and active-drug-controlled trials. Three of the trials were in elderly patients (n = 1,019). It has also been studied in transient insomnia (n = 264). Because of its very short half-life, studies focused on decreasing sleep latency, with less attention to duration of sleep and number of awakenings, for which consistent differences from placebo were not demonstrated. Studies were also carried out to examine the time course of effects on memory and psychomotor function, and to examine withdrawal phenomena.

Transient Insomnia

Normal adults experiencing transient insomnia during the first night in a sleep laboratory were evaluated in a double-blind, parallel-group trial comparing the effects of two doses of Sonata (5 mg and 10 mg) with placebo. Sonata 10 mg, but not 5 mg, was superior to placebo in decreasing latency to persistent sleep (LPS), a polysomnographic measure of time to onset of sleep.

Chronic Insomnia

Non-Elderly Patients

Adult outpatients with chronic insomnia were evaluated in three double-blind, parallel-group outpatient studies, one of 2 weeks duration and two of 4 weeks duration, that compared the effects of Sonata at doses of 5 mg (in two studies), 10 mg, and 20 mg with placebo on a subjective measure of time to sleep onset (TSO). Sonata 10 mg and 20 mg were consistently superior to placebo for TSO, generally for the full duration of all three studies. Although both doses were effective, the effect was greater and more consistent for the 20-mg dose. The 5-mg dose was less consistently effective than were the 10-mg and 20-mg doses. Sleep latency with Sonata 10 mg and 20 mg was on the order of 10-20 minutes (15%-30%) less than with placebo in these studies.

Adult outpatients with chronic insomnia were evaluated in six double-blind, parallel-group sleep laboratory studies that varied in duration from a single night up to 35 nights. Overall, these studies demonstrated a superiority of Sonata 10 mg and 20 mg over placebo in reducing LPS on the first 2 nights of treatment. At later time points in 5-, 14-, and 28-night studies, a reduction in LPS from baseline was observed for all treatment groups, including the placebo group, and thus, a significant difference between Sonata and placebo was not seen beyond 2 nights. In a 35-night study, Sonata 10 mg was significantly more effective than placebo in reducing LPS at the primary efficacy endpoint on nights 29 and 30.

Elderly Patients

Elderly outpatients with chronic insomnia were evaluated in two 2-week, double-blind, parallel-group outpatient studies that compared the effects of Sonata 5 mg and 10 mg with placebo on a subjective measure of time to sleep onset (TSO). Sonata at both doses was superior to placebo on TSO, generally for the full duration of both studies, with an effect size generally similar to that seen in younger persons. The 10-mg dose tended to have a greater effect in reducing TSO.

Elderly outpatients with chronic insomnia were also evaluated in a 2-night sleep laboratory study involving doses of 5 mg and 10 mg. Both 5-mg and 10-mg doses of Sonata were superior to placebo in reducing latency to persistent sleep (LPS).

Generally in these studies, there was a slight increase in sleep duration, compared to baseline, for all treatment groups, including placebo, and thus, a significant difference from placebo on sleep duration was not demonstrated.

Studies Pertinent To Safety Concerns For Sedative/Hypnotic Drugs

Memory Impairment

Studies involving the exposure of normal subjects to single fixed doses of Sonata (10 mg or 20 mg) with structured assessments of short-term memory at fixed times after dosing (e.g., 1, 2, 3, 4, 5, 8, and 10 hours) generally revealed the expected impairment of short-term memory at 1 hour, the time of peak exposure to zaleplon, for both doses, with a tendency for the effect to be greater after 20 mg. Consistent with the rapid clearance of zaleplon, memory impairment was no longer present as early as 2 hours post dosing in one study, and in none of the studies after 3-4 hours. Nevertheless, spontaneous reporting of adverse events in larger premarketing clinical trials revealed a difference between Sonata and placebo in the risk of next-day amnesia (3% vs 1%), and an apparent dose-dependency for this event (see ADVERSE REACTIONS).

Sedative/Psychomotor Effects

Studies involving the exposure of normal subjects to single fixed doses of Sonata (zaleplon) (10 mg or 20 mg) with structured assessments of sedation and psychomotor function (e.g., reaction time and subjective ratings of alertness) at fixed times after dosing (e.g., 1, 2, 3, 4, 5, 8, and 10 hours) generally revealed the expected sedation and impairment of psychomotor function at 1 hour, the time of peak exposure to zaleplon, for both doses. Consistent with the rapid clearance of zaleplon, impairment of psychomotor function was no longer present as early as 2 hours post dosing in one study, and in none of the studies after 3-4 hours. Spontaneous reporting of adverse events in larger premarketing clinical trials did not suggest a difference between Sonata and placebo in the risk of next-day somnolence (see ADVERSE REACTIONS).

Withdrawal-Emergent Anxiety And Insomnia

During nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of hypnotics may develop. If the drug has a short elimination half-life, it is possible that a relative deficiency of the drug or its active metabolites (i.e., in relationship to the receptor site) may occur at some point in the interval between each night’s use. This sequence of events is believed to be responsible for two clinical findings reported to occur after several weeks of nightly use of other rapidly eliminated hypnotics: increased wakefulness during the last quarter of the night and the appearance of increased signs of daytime anxiety.

Zaleplon has a short half-life and no active metabolites. At the primary efficacy endpoint (nights 29 and 30) in a 35-night sleep laboratory study, polysomnographic recordings showed that wakefulness was not significantly longer with Sonata than with placebo during the last quarter of the night. No increase in the signs of daytime anxiety was observed in clinical trials with Sonata. In two sleep laboratory studies involving 14- and 28-nightly doses of Sonata (5 mg and 10 mg in one study and 10 mg and 20 mg in the second) and structured assessments of daytime anxiety, no increases in daytime anxiety were detected. Similarly, in a pooled analysis (all the parallel-group, placebo-controlled studies) of spontaneously reported daytime anxiety, no difference was observed between Sonata and placebo.

Rebound insomnia, defined as a dose-dependent temporary worsening in sleep parameters (latency, total sleep time, and number of awakenings) compared to baseline following discontinuation of treatment, is observed with short- and intermediate-acting hypnotics. Rebound insomnia following discontinuation of Sonata relative to baseline was examined at both nights 1 and 2 following discontinuation in three sleep laboratory studies (14, 28, and 35 nights) and five outpatient studies utilizing patient diaries (14 and 28 nights). Overall, the data suggest that rebound insomnia may be dose dependent. At 20 mg, there appeared to be both objective (polysomnographic) and subjective (diary) evidence of rebound insomnia on the first night after discontinuation of treatment with Sonata. At 5 mg and 10 mg, there was no objective and minimal subjective evidence of rebound insomnia on the first night after discontinuation of treatment with Sonata. At all doses, the rebound effect appeared to resolve by the second night following withdrawal. In the 35-night study, there was a worsening in sleep on the first night off for both the 10-mg and 20-mg groups compared to placebo, but not to baseline. This discontinuation-emergent effect was mild, had the characteristics of the return of the symptoms of chronic insomnia, and appeared to resolve by the second night after zaleplon discontinuation.

Other Withdrawal-Emergent Phenomena

The potential for other withdrawal phenomena was also assessed in 14- to 28-night studies, including both the sleep laboratory studies and the outpatient studies, and in open-label studies of 6- and 12-month durations. The Benzodiazepine Withdrawal Symptom Questionnaire was used in several of these studies, both at baseline and then during days 1 and 2 following discontinuation. Withdrawal was operationally defined as the emergence of 3 or more new symptoms after discontinuation. Sonata was not distinguishable from placebo at doses of 5 mg, 10 mg, or 20 mg on this measure, nor was Sonata distinguishable from placebo on spontaneously reported withdrawal-emergent adverse events. There were no instances of withdrawal delirium, withdrawal associated hallucinations, or any other manifestations of severe sedative/hypnotic withdrawal.

ICH GCP | Clinical Trials Registry

Inclusion Criteria: – non-smokers – at least 18 years of age – BMI of 30 or less Exclusion Criteria: – Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study. – Subjects whose clinical laboratory test values are outside the reference ranges may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant. – Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study. Subjects with intolerance to alcohol or other CNS depressants should not participate in this study. – Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required. – All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate. – Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study. – Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate. – Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 14 days of dosing or implanted or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate. – All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study. – Subjects who do not tolerate venipuncture will not be allowed to participate.

Sonata Addiction, Abuse and Treatment

Understanding Sonata

A nonbenzodiazepine hypnotic prescribed to treat insomnia, Sonata is the brand name for zaleplon. It sits among the popular prescription “Z-drugs” Lunesta and Ambien as a prominent sleep aid in America.

Sonata activates the neurotransmitter gamma-Aminobutyric acid (GABA), slowing mental processes, blocking feelings of anxiety and stress, and producing sedative effects to help patients enjoy healthy, restful sleep. Users take Sonata orally as a capsule or tablet. Slang terms for Sonata include downers, tranks and sleepeasy.

Sonata Abuse and Effects

Sonata is one of the fastest-acting sleeping pills available, with a terminal half-life of an hour. As such, Sonata is a prime target for accidental and recreational abuse, as people might overuse the drug as an immediate sleep aid. Like Lunesta and Ambien, Sonata is federally regulated as a Schedule IV controlled substance. Sonata is not considered as habit-forming as some sleep medicines, such as Ambien and Lunesta. It is, however, more likely to cause withdrawal symptoms if you suddenly stop using it after approximately 2 weeks of daily use. Any pattern of Sonata use deviating from a physician’s recommendation qualifies as abuse.

Those abusing Sonata will experience a mild, euphoric rush punctuated with bouts of hallucinations and “blackouts,” or intermittent memory loss.

Those abusing Sonata may break capsules open or crush tablets and snort their contents, intensifying the drug’s “buzz” and hallucinatory properties (which only occur at extremely high doses). Sonata’s unique sedative effect on the brain can also trigger unnerving behaviors in users — sleep-walking, sleep-eating and driving and even having sex while asleep — all without recollection of performing them. This is known as parasomnia. Forcing oneself awake after ingesting Sonata significantly raises the risk of unconscious behavior. Side effects of Sonata abuse might include:

  • Mental confusion
  • Nausea and vomiting
  • Amnesia
  • Numbness or tingling
  • Hallucinations
  • Impaired coordination
  • Aggression and irritability
  • Headache
  • Fatigue
  • Dizziness
  • Abdominal pain
  • Tremors
  • Mood swings
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Sonata is not as potent as some of its Z-drug counterparts, but the danger of abuse persists. Overdosing on Sonata alone is relatively uncommon, but co-abusing the prescription drug alongside other CNS depressants like alcohol — which happens frequently — can depress respiratory function to the point of failure and death.

Attempted suicides are the most common emergency room admission associated with Sonata use.

Signs of a Sonata Addiction

Signs of a Sonata addiction can be hard for friends and family to spot. It can be difficult to tell the difference between addictive and prescriptive use of the drug. However, changes in behavior such as doctor shopping — acquiring multiple prescriptions for the drug — and using Sonata for any unprescribed purpose should be considered troubling.

One telltale sign of Sonata addiction is a built tolerance to the drug’s effects and subsequent withdrawals when quitting use. Sufferers might experience “rebound insomnia” (or a resurgent, intensified case of insomnia), a notorious withdrawal symptom and sign of chemical dependency. With long enough use someone may not be able to fall asleep without taking Sonata. Learn the criteria professionals use to diagnose addiction now.

Some signs of Sonata addiction include:

  • Rationalizing behavior to justify Sonata use
  • Inability to quit after multiple attempts to do so
  • Neglecting major responsibilities at work, home, or school
  • Inability to function without the use of Sonata
  • Taking Sonata in unintended ways, such as during the day
  • Having cravings or urges to use Sonata
  • Preoccupation with wanting to use Sonata
  • Stealing in order to obtain Sonata
  • Excessive sleep or drowsiness
  • Taking Sonata in larger doses than prescribed
  • Using Sonata in methods other than prescribed
  • Doctor shopping
  • Increased tolerance
  • Withdrawal symptoms upon decrease of dosage ceasing use
  • Engaging in hazardous behaviors while under the influence of Sonata
  • Verbal concerns from family members or friends about changes in mood and behavior or use of Sonata
  • Isolation from family and friends

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Sonata Addiction Treatment

Sonata packs less of a punch than Ambien or Lunesta regarding addictive potential, but over a long enough period of use, an addiction can develop.

Once the mind and body become dependent on Sonata, excruciating withdrawal symptoms can follow quitting use.

The type and duration of withdrawal symptoms that Sonata users will experience are determined by a number of factors. Some of these include:

  • Length of time a person has been using Sonata
  • The average dose of Sonata they regularly took
  • How frequently they took Sonata
  • Whether the person used Sonata with alcohol or any other drugs
  • The person’s mental health and medical history
  • The person’s gender
  • The person’s body weight
  • How the individual took Sonata

Sonata’s impact on brain chemistry essentially renders addiction sufferers incapable of functioning without it. Abruptly stopping Sonata use can induce convulsions, hallucinations and even seizures.

Treatment programs for Sonata addiction are usually provided in residential and outpatient models, and the level of care depends on several factors, such as the amount of support at home, type and manner of drugs abused, any underlying medical or mental health concerns, and the severity of the drug dependence. Before admission to any rehab program, a substance abuse assessment must be completed by an addiction professional to determine if it is appropriate for the potential patient.

Inpatient Sonata Rehab

Inpatient rehab offers 24-hour supervised care at a live-in facility. Both psychiatric and physical health assistance are included in inpatient rehab. On average, clients will remain in inpatient rehab between 30 to 90 days. The goal of inpatient rehab is to return clients to a more independent lifestyle that does not involve the use of Sonata to cope with difficult emotions or life stressors. It provides education about the disease of addiction, while teaching healthy coping skills for relapse prevention, trauma, anxiety, depression, and other struggles.

Outpatient Sonata Rehab

Unlike inpatient treatment, outpatient rehab does not require patients to stay at a treatment facility or have supervised medical care to address medical conditions. Outpatient rehab can be very useful for individuals who must continue to work or attend school or for adults with children who are unable to attend treatment for months at a time. There are various types of outpatient rehab programs that vary in intensity depending on the client’s needs. Typically, an outpatient program will require meeting at least a couple times per week for a few hours each session. Outpatient treatment often involves group therapy, individual therapy, family therapy, and specialized therapy types, such as art or music therapy.

Outpatient therapy can also be used as an aftercare or step-down program upon completion of inpatient rehab to assist the client transition back into their daily life while maintaining their recovery.

Sometimes, patients attend outpatient programs while staying in a sober living home, or a residence in which drugs and alcohol are prohibited. In sober homes, residents typically are subject to periodic drug screenings and restrictions on curfew to ensure they remain sober.

Therapy for Sonata Addiction

Addiction treatment for Sonata may include the use of many types of therapy to help a person recover. Behavioral therapies like motivational interviewing (MI) and cognitive behavioral therapy (CBT) teach healthy coping mechanisms for stress and help individuals uncover the root cause of why they may be abusing drugs. They also help patients avoid or manage potential triggers. MI is a non-confrontational approach that aids individuals in finding the internal motivation to change while learning to accept themselves for who they are. CBT works to turn negative thoughts into positive ones, thus influencing self-esteem and modifying behaviors in turn.

Group and individual therapy and counseling sessions are typical aspects of a Sonata abuse treatment program. Relapse prevention tools and communication skills are taught during these sessions. Support groups are formed that may help individuals to build a network of peers with a common interest and goal in remaining drug-free.

Improving Sleep in Sonata Addiction Treatment

Since Sonata is a sleep aid, individuals who are addicted to the drug may suffer from difficulties sleeping. Holistic methods may be useful during Sonata treatment and recovery to improve sleep. Yoga, meditation, mindfulness techniques, chiropractic care, stress management techniques, acupuncture, massage therapy, nutritional meal planning, and fitness programs may all be beneficial in promoting healthy sleep habits.

Methods of reducing stress and anxiety, which may include the use of antidepressant or anti-anxiety medications, may also be helpful. When someone is well-rested, that person is better able to handle stressors and think clearly. As a result, improving sleep quality can enhance overall quality of life.

Tips for improving sleep include:

  • Setting and sticking to a regular sleep schedule with set wake and sleep times
  • Eating a balanced diet
  • Avoiding caffeine
  • Engaging in regular physical activity
  • Using relaxation techniques
  • No naps during the day
  • Avoiding stimulation right before bed
  • Keeping the bedroom dark and using it mainly for sleep

Sonata Abuse Statistics

million

Americans filled approximately 60 million prescriptions for sleeping pills in 2011.

44%

higher risk

People taking sleeping pills have about a 44 percent higher risk of developing infections such as sinusitis, upper respiratory tract infections, herpes and more.

children

Approximately one in 500 children in the United States are on sleeping pills.

Suicidal ideation can manifest and lead to tragedy, as well. Physician-proctored detoxification helps diminish severe withdrawals, allows for behavioral observation, and reduces the potential for adverse complications such as seizures. Treatment centers across the country focus on helping Sonata addiction sufferers recover mentally and physically, as well as decreasing the odds of relapse.

Take Back Your Health

Prescription sleeping pill addiction plagues millions of Americans, but hope for recovery is out there. Community support groups and inpatient and outpatient treatment programs can equip sufferers with the resources needed to overcome this debilitating struggle. Overcome your Sonata addiction today.

FDA: Here Are The New Warnings About Sleeping Pills Like Ambien, Lunesta, Sonata

BLOOMBERG NEWS

Sleepwalking, sleep-driving, and sleep-using-a-stove are not things that you want to do. Therefore, the U.S. Food and Drug Administration on Tuesday announced that eszopiclone, zaleplon, and zolpidem will now have to include “boxed warnings” of such possible side effects.

If you think that these three things sound like Klingon language, they aren’t. The FDA has no purview over Klingons. Instead, these terms are actually generic names for three types of popular sleep medications. You may have heard of Lunesta, which is eszopiclone. Sonata is zaleplon. Zolpidem goes by the names of Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist.

The FDA is concerned that these medications may in some cases result in “complex sleep behaviors.” In this case, a complex sleep behavior is not sleeping in Iron Man pajamas or having far too many pillows on your bed. It is unknowingly engaging in activities that you normally shouldn’t be doing while asleep.

An FDA review of the FDA Adverse Event Reporting System (FAERS) database found 62 cases of serious injuries from complex sleep behaviors after people took eszopiclone, zaleplon, or zolpidem from December 16, 1992, to February 27, 2018. A review of the medical literature revealed four more cases reported from December 16, 1992, to March 13, 2018. Deaths occurred in 20 of these 66 cases. Of the ones that survived, 46 suffered serious injuries. People did all kinds of things, ranging from falling to crashing cars to shooting themselves to committing suicide in various ways to drowning to burning themselves to killing someone else. No, these weren’t all just simple walks in the park, although that can happen. In most cases, the patients had no clue what they were doing while asleep, until, of course, someone told them after they awoke.

Patients took zolpidem in 61 of the 66 cases, whereas they took eszopiclone in 3 and zaleplon in 2 of the cases. The FDA did add that zolpidem is much more commonly prescribed than eszopiclone and zaleplon.

Based this review, the FDA indicated the following: “As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.”

Note that the boxed warning will not include “making a bust of soccer star Brandi Chastain that looks nothing like Brandi Chastain”:

Artist now blaming Ambien for the Brandi Chastain bust. pic.twitter.com/hDuMkc7bAC

— Alex Kaseberg (@AlexKaseberg) May 30, 2018

In the announcement, FDA Acting Commissioner Ned Sharpless, M.D. said the following:

We recognize that millions of Americans suffer from insomnia and rely on these drugs to help them sleep better at night. While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk. These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses. Today’s action is an important step in our ongoing effort to call more attention to these critical safety issues and serves as an example of our ongoing commitment to ensuring that patients and health care professionals have the information they need to make informed treatment decisions.

As Sharpless indicated, these behaviors could happen the first time you take the medications and on any dose. Therefore, if you decide to try Ambien once, don’t be too surprised if you awake next to a bust of someone who does not look like Brandi Chastain.

Of course, Sharpless did indicate that serious incidents after taking these three types of medications are rare. However, many complex sleep behaviors may go unreported because, after all, you are asleep when they happen. Even when someone else is witnessing your behaviors, he or she may not necessarily report them to the FDA or write up a medical case report, submit it to a scientific journal, and get it published. (If your friend is following you around just to get material for medical case reports, that person may not really be your friend.) Moreover, it isn’t clear how frequently sleep medications may lead to behaviors that aren’t necessarily life-threatening but could be health, reputation, relationship, or work threatening. For example, someone once sleep texted me after taking Ambien. And, no, I am not going to tell you what she said.

Even if more studies were done to determine the overall risk of different complex sleep behaviors after taking eszopiclone, zaleplon, or zolpidem, every person and apparently every time you take the pills may be different. Even if you have been taking one of these medications for a while without incident, could this be the one time that you sleep-while-making-waffles? What precautions, then, should you take?

This is not practicing good sleep hygiene. (Photo: Getty Images)

Getty

First of all, sleep medications should never be the first option when you have trouble sleeping. Always opt for practicing good sleep hygiene first. This doesn’t mean taking a bath before you go to bed, although being covered in mud head-to-toe may prevent you from falling asleep. The National Sleep Foundation defined sleep hygiene as “a variety of different practices and habits that are necessary to have good nighttime sleep quality and full daytime alertness.”

Good sleep hygiene includes being careful what you eat, drink, or smoke (such as spicy foods, carbonated beverages, caffeine, and nicotine) close to bedtime, limiting daytime naps to 30 minutes, and getting enough exercise and light exposure during the day. Of course, exercise too close to sleep time can keep you awake so no Riverdancing right before you get into bed. Make sure you find ways to relax before bedtime. For example, don’t read emails or tweets that may aggravate you. Have a personalized routine that will put your mind and body at ease. Keep your sleep quarters comfortable. For many, that means relatively cool at 60 to 67 degrees Fahrenheit. And make sure you turn off that strobe light and disco ball in your bedroom when it is time to get some shut eye.

Secondly, don’t always stress about getting a good night’s sleep. Nearly everyone has trouble sleeping here and there. So if it is an occasional problem, you can always stay up binge watching Charmed. It may be better to feel a bit tired the next day than unconsciously making busts that do not look like Brandi Chastain. Difficulty sleeping is only a problem when it is recurring or really interfering with your life.

If you do continue to regularly struggle to get good sleep, see a doctor. Again, medications should be more of a last resort. Do not take sleep medications without the advice and supervision of a doctor. A real doctor. A competent doctor. A caring doctor. Moreover, a medical condition may be affecting your sleep, so he or she may want rule out some of these possibilities.

If you do find yourself having to take eszopiclone, zaleplon, or zolpidem, take precautions. Tell your partner or whomever may be sleeping near you that you are taking the medication. If someone is sleeping in your bed and you do not know the person, ask the person who he or she is before telling that person anything. Properly store and secure any items that may be dangerous and easily reachable while you are sleeping. If you do exhibit any complex sleep behaviors, tell your doctor immediately. You don’t want to sleep on anything that may end up harming you in the future.

Sonata is the brand name for a newer type of prescription sleep aid called zaleplon. Zaleplon is a hypnotic, meaning that it works on specific areas of the brain to help relax the patient. By feeling more relaxed, the patient is then able to fall asleep. Sonata, or zaleplon, is a newer sleep aid medication that is prescribed to patients who have trouble falling asleep. Sonata is not prescribed to patients who have trouble staying asleep.

Sonata was approved by the U.S. Food and Drug Administration (FDA) in 1999 as a non-benzodiazepine prescription medication used to treat insomnia. Patients are typically prescribed between 5mg and 20mg doses, and they are told to take Sonata right before going to bed. If a patient takes Sonata too early, the patient may still experience unrestful sleep, dizziness, drowsiness, or memory loss. In addition, patients must only take Sonata when they plan to get a full night of sleep. If a patient takes Sonata and sleeps less than 4 hours, the risk of memory loss, dizziness, or drowsiness is increased.

Sonata Risks

There has been an increasing amount of debate over which types of sleep aids are safest and most effective. Patients are also questioning whether “non-habit forming” sleep aids are actually less addictive than older sleep medications. According to Consumer Reports, new sleep medications such as Sonata are still highly addictive, without being any safer or more effective than older medications.

Using Sonata places patients at risk of the following:

  • Anaphylaxis, or severe allergic reaction
  • Angioedema, or severe facial swelling
  • Daytime drowsiness
  • Dizziness
  • Memory loss, or lapse in memory
  • Unsteadiness, or loss of coordination
  • Sleep walking, sleep eating, sleep driving, and other odd behaviors such as making phone calls or having sex and not remembering
  • Hallucinations
  • Rebound insomnia, whenever the patients stops using Sonata
  • Development of certain cancers

Sonata FDA Warning

In 2007, the FDA requested that all sedative-hypnotic manufacturers expand their sleep aid warning labels. The expanded sleep aid warning labels, for drugs such as Sonata, were to include warnings regarding severe allergic reactions and facial swelling. Allergic reactions and facial swelling from sleep aid medication are particularly dangerous because the patient may struggle to breathe.

The FDA’s sleep aid warnings also required sedative-hypnotic manufacturers to include behavioral information on their sleep aid warning labels. Complex behaviors can occur as the result of taking a sleep aid. This includes sleep driving, sleep eating, and sleep walking. In elderly patients, odd behavioral activity is likely to result in a serious fall and unexpected death.

Elderly Hip Fractures

In a recent study, researchers from Harvard Medical School analyzed the effect of insomnia and prescription sleep aid medications on memory, balance, and other cognitive capabilities of elderly patients. The researchers focus on non-benzodiazepine sleep aids, such as Sonata. To do this, the Harvard researchers used medical records from assisted living facilities and nursing homes.

The findings were published in the JAMA Internal Medicine medical journal. According to the study, using non-benzodiazepine sleep aids, such as Sonata, increased the likelihood of hip fracture in elderly patients by 66 percent. The newest users, who had just started using non-benzodiazepine sleep medication such as Sonata, were the most likely to suffer a fall and a hip fracture.

Sleeping Pill Death

Other studies have shown a link between sleep aid use and unexpected sleeping pill death. One study indicated that prescription sleep aids quadrupled the likelihood of premature, sudden death in patients. In another recent study, patients who took sleeping aids such as Sonata were found to have a 35-percent increased risk of cancer.

Sleep Aids Linked to Cancer

Types of cancer that were linked to sleep aid use, such as Sonata, include:

  • Prostate cancer
  • Lung cancer
  • Colon cancer
  • Lymphoma

Sonata Consumer Reports

Consumer Reports did a study on Sonata, and other non-benzodiazepine sleep aids, to evaluate the risks, expenses, and effectiveness of these sleep medications. According to consumer reports, newer prescription sleep aids such as Sonata were not safer or more effective than older sleep aid medications. Furthermore, new medications such as Sonata presented less long-term information and cost more money for patients to use.

Consumer Reports concluded that the best method for addressing insomnia was through psychotherapy. Consumer Reports noted the benefits of short-term sleep aid use, such as Sonata, in very severe cases of insomnia. However, Consumer Reports cautioned against long-term use of Sonata and other non-benzodiazepine sleep aids. The Consumer Reports study was conducted in January 2012.

SIDE EFFECTS

The premarketing development program for Sonata included zaleplon exposures in patients and/or normal subjects from 2 different groups of studies: approximately 900 normal subjects in clinical pharmacology/pharmacokinetic studies; and approximately 2,900 exposures from patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 450 patient exposure years. The conditions and duration of treatment with Sonata varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, COSTART terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings Observed In Short-Term, Placebo-Controlled Trials

Adverse Events Associated With Discontinuation Of Treatment

In premarketing placebo-controlled, parallel-group phase 2 and phase 3 clinical trials, 3.1% of 744 patients who received placebo and 3.7% of 2,149 patients who received Sonata discontinued treatment because of an adverse clinical event. This difference was not statistically significant. No event that resulted in discontinuation occurred at a rate of ≥ 1%.

Adverse Events Occurring At An Incidence Of 1% Or More Among Sonata 20 mg-Treated Patients

Table 1 enumerates the incidence of treatment-emergent adverse events for a pool of three 28night and one 35-night placebo-controlled studies of Sonata at doses of 5 mg or 10 mg and 20 mg. The table includes only those events that occurred in 1% or more of patients treated with Sonata 20 mg and that had a higher incidence in patients treated with Sonata 20 mg than in placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Table 1 : Incidence (%) of Treatment-Emergent Adverse Events in Long-Term (28 and 35 Nights) Placebo-Controlled Clinical Trials of Sonataa

Body System
Preferred Term

Placebo
(n = 344)

Sonata 5 mg or 10 mg
(n = 569)
Sonata 20 mg
(n = 297)
Body as a whole
Abdominal pain 3 6 6
Asthenia 5 5 7
Headache 35 30 42
Malaise < 1 < 1 2
Photosensitivity reaction < 1 < 1 1
Digestive system
Anorexia < 1 < 1 2
Colitis 0 0 1
Nausea 7 6 8
Metabolic and nutritional
Peripheral edema < 1 < 1 1
Nervous system
Amnesia 1 2 4
Confusion < 1 < 1 1
Depersonalization < 1 < 1 2
Dizziness 7 7 9
Hallucinations < 1 < 1 1
Hypertonia < 1 1 1
Hypesthesia < 1 < 1 2
Paresthesia 1 3 3
Somnolence 4 5 6
Tremor 1 2 2
Vertigo < 1 < 1 1
Respiratory system
Epistaxis < 1 < 1 1
Special senses
Abnormal vision < 1 < 1 2
Ear pain 0 < 1 1
Eye pain 2 4 3
Hyperacusis < 1 1 2
Parosmia < 1 < 1 2
Urogenital system
Dysmenorrhea 2 3 4
a Events for which the incidence for Sonata 20 mg-treated patients was at least 1% and greater than the incidence among placebo-treated patients. Incidence greater than 1% has been rounded to the nearest whole number.

Other Adverse Events Observed During The Premarketing Evaluation Of Sonata

Listed below are COSTART terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section. These events were reported by patients treated with Sonata (zaleplon) at doses in a range of 5 mg/day to 20 mg/day during premarketing phase 2 and phase 3 clinical trials throughout the United States, Canada, and Europe, including approximately 2,900 patients. All reported events are included except those already listed in Table 1 or elsewhere in labeling, those events for which a drug cause was remote, and those event terms that were so general as to be uninformative. It is important to emphasize that although the events reported occurred during treatment with Sonata, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1,000 patients; rare events are those occurring in fewer than 1/1,000 patients.

Body as a whole -Frequent: back pain, chest pain, fever; Infrequent: chest pain substernal, chills, face edema, generalized edema, hangover effect, neck rigidity.

Cardiovascular system -Frequent: migraine; Infrequent: angina pectoris, bundle branch block, hypertension, hypotension, palpitation, syncope, tachycardia, vasodilatation, ventricular extrasystoles; Rare: bigeminy, cerebral ischemia, cyanosis, pericardial effusion, postural hypotension, pulmonary embolus, sinus bradycardia, thrombophlebitis, ventricular tachycardia.

Digestive system -Frequent: constipation, dry mouth, dyspepsia; Infrequent: eructation, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, glossitis, increased appetite, melena, mouth ulceration, rectal hemorrhage, stomatitis; Rare: aphthous stomatitis, biliary pain, bruxism, cardiospasm, cheilitis, cholelithiasis, duodenal ulcer, dysphagia, enteritis, gum hemorrhage, increased salivation, intestinal obstruction, abnormal liver function tests, peptic ulcer, tongue discoloration, tongue edema, ulcerative stomatitis.

Endocrine system -Rare: diabetes mellitus, goiter, hypothyroidism.

Hemic and lymphatic system -Infrequent: anemia, ecchymosis, lymphadenopathy; Rare: eosinophilia, leukocytosis, lymphocytosis, purpura.

Nervous system -Frequent: anxiety, depression, nervousness, thinking abnormal (mainly difficulty concentrating); Infrequent: abnormal gait, agitation, apathy, ataxia, circumoral paresthesia, emotional lability, euphoria, hyperesthesia, hyperkinesia, hypotonia, incoordination, insomnia, libido decreased, neuralgia, nystagmus; Rare: CNS stimulation, delusions, dysarthria, dystonia, facial paralysis, hostility, hypokinesia, myoclonus, neuropathy, psychomotor retardation, ptosis, reflexes decreased, reflexes increased, sleep talking, sleep walking, slurred speech, stupor, trismus.

Respiratory system -Frequent: bronchitis; Infrequent: asthma, dyspnea, laryngitis, pneumonia, snoring, voice alteration; Rare: apnea, hiccup, hyperventilation, pleural effusion, sputum increased.

Skin and appendages -Frequent: pruritus, rash; Infrequent: acne, alopecia, contact dermatitis, dry skin, eczema, maculopapular rash, skin hypertrophy, sweating, urticaria, vesiculobullous rash; Rare: melanosis, psoriasis, pustular rash, skin discoloration.

Special senses -Frequent: conjunctivitis, taste perversion; Infrequent: diplopia, dry eyes, photophobia, tinnitus, watery eyes; Rare: abnormality of accommodation, blepharitis, cataract specified, corneal erosion, deafness, eye hemorrhage, glaucoma, labyrinthitis, retinal detachment, taste loss, visual field defect.

Urogenital system -Infrequent: bladder pain, breast pain, cystitis, decreased urine stream, dysuria, hematuria, impotence, kidney calculus, kidney pain, menorrhagia, metrorrhagia, urinary frequency, urinary incontinence, urinary urgency, vaginitis; Rare: albuminuria, delayed menstrual period, leukorrhea, menopause, urethritis, urinary retention, vaginal hemorrhage.

Postmarketing Reports

Anaphylactic/anaphylactoid reactions, including severe reactions, and nightmares.

Drug Abuse And Dependence

Controlled Substance Class

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

Abuse, Dependence, And Tolerance

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. Physical dependence is a state of adaption 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. 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’s effects over time. Tolerance may occur to both the 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, utilizing a multidisciplinary approach, but relapse is common.

Abuse

Two studies assessed the abuse liability of Sonata at doses of 25 mg, 50 mg, and 75 mg in subjects with known histories of sedative drug abuse. The results of these studies indicate that Sonata has an abuse potential similar to benzodiazepine and benzodiazepine-like hypnotics.

Dependence

The potential for developing physical dependence on Sonata and a subsequent withdrawal syndrome was assessed in controlled studies of 14-, 28-, and 35-night durations and in open-label studies of 6- and 12-month durations by examining for the emergence of rebound insomnia following drug discontinuation. Some patients (mostly those treated with 20 mg) experienced a mild rebound insomnia on the first night following withdrawal that appeared to be resolved by the second night. The use of the Benzodiazepine Withdrawal Symptom Questionnaire and examination of any other withdrawal-emergent events did not detect any other evidence for a withdrawal syndrome following abrupt discontinuation of Sonata therapy in pre-marketing studies.

However, available data cannot provide a reliable estimate of the incidence of dependence during treatment at recommended doses of Sonata. Other sedative/hypnotics have been associated with various signs and symptoms following abrupt discontinuation, ranging from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. Seizures have been observed in two patients, one of which had a prior seizure, in clinical trials with Sonata. Seizures and death have been seen following the withdrawal of zaleplon from animals at doses many times higher than those proposed for human use. Because individuals with a history of addiction to, or abuse of, drugs or alcohol are at risk of habituation and dependence, they should be under careful surveillance when receiving Sonata or any other hypnotic.

Tolerance

Possible tolerance to the hypnotic effects of Sonata 10 mg and 20 mg was assessed by evaluating time to sleep onset for Sonata compared with placebo in two 28-night placebo-controlled studies and latency to persistent sleep in one 35-night placebo-controlled study where tolerance was evaluated on nights 29 and 30. No development of tolerance to Sonata was observed for time to sleep onset over 4 weeks.

Read the entire FDA prescribing information for Sonata (Zaleplon)

Federal health regulators announced on Tuesday that they would require manufacturers of sleeping pills such as Ambien and related drugs to post strongly worded warnings in boxes on labels and patient guides. The Food and Drug Administration, in what it called a safety announcement, noted that the drugs’ side effects included risky behaviors, such as sleepwalking and sleep driving, that can lead to injury and even death.

The F.D.A. singled out Ambien and two other popular sleep aids, Lunesta and Sonata, as well as three formulations of zolpidem, the generic name for Ambien. The boxed warnings — the most prominent form of warning required by the agency — must list side effects such as sleepwalking and sleep driving, in which people using the drugs take risks without being fully awake.

The agency said such reactions were rare but could lead to injuries or death; it advised doctors not to prescribe the drugs to people who have had such side effects in the past.

“Patients, stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behavior where you engage in activities while you are not fully awake,” the agency’s safety alert said, “or if you do not remember activities you have done while taking the medicine.”

Before taking zaleplon,

  • tell your doctor and pharmacist if you are allergic to zaleplon, aspirin, any other medications, tartrazine (a yellow dye in some processed foods and drugs), or any of the ingredients in zaleplon capsules. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines such as diphenhydramine (Benadryl) or promethazine; barbiturates; cimetidine (Tagamet); cough and cold medicines; erythromycin; ibuprofen; imipramine (Tofranil); ketoconazole (Nizoral); medications for allergies such as diphenhydramine (Benadryl), depression, or mental illness; certain medications for seizures such as phenytoin (Dilantin), carbamazepine (Epitol, Tegretol, others), and phenobarbital; pain relievers; promethazine (Promethegan); rifampin (Rifadin, Rimactane); sedatives, other sleeping pills, thioridazine, and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol and if you use or have ever used street drugs or have overused prescription medications. Also tell your doctor if you have ever thought about killing yourself or tried to do so and if you have or have ever had depression, mental illness, seizures, lung disease or breathing problems, or kidney or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking zaleplon, call your doctor.
  • talk to your doctor about the risks and benefits of taking zaleplon if you are 65 years of age or older. Older adults should not usually take zaleplon because it is not as safe or effective as other medications that can be used to treat the same condition.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking zaleplon.
  • you should know that this medication may cause drowsiness, decreased mental alertness, prolonged reaction time, problems with coordination the day after you take it, blurry or double vision, and may increase the risk that you could fall. Take extra care to be sure you do not fall, especially if you get out of bed in the middle of the night. Your ability to drive or operate machinery the day after you take zaleplon may be impaired even if you feel fully awake. Do not drive a car or operate machinery until you know how zaleplon affects you.
  • do not drink alcohol while you are taking zaleplon. Alcohol can make the side effects of zaleplon worse.
  • you should know that your mental health may change in unexpected ways while you are taking this medication. These changes may be caused by zaleplon or they may be caused by physical or mental illnesses that you already have or that you develop during your treatment. Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, new or worsening depression, thinking about killing yourself, confusion, and any other changes in your usual thoughts or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.

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