ZALEPLON

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ZALEPLON

  • [SONATA]

DEA CODE 2781: Schedule 4

Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia. While 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 (GABABZ) receptor complex. Subunit modulation of the GABABZ 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. Zaleplon also binds selectively to the CNS GABAA-receptor chloride ionophore complex at benzodiazepine(BZ) omega-1 (BZ1, o1) receptors. Zaleplon exerts its action through subunit modulation of the GABABZ receptor chloride channel macromolecular complex. Zaleplon also binds selectively to the brain omega-1 receptor located on the alpha subunit of the GABA-A/chloride ion channel receptor complex and potentiates t-butyl-bicyclophosphorothionate (TBPS) binding. Zaleplon is marketed under the brand names Sonata, Starnoc, and Andante.

Uses:
This medication is used for a short time to treat people who have trouble falling asleep.

If you have other sleep problems such as not being able to sleep through the night, this medication may not be right for you.

Zaleplon is known as a hypnotic. It works on certain centers in the brain to relax you and help you fall asleep faster.

Used for:

Trouble falling asleep

Before Using:
Tell your doctor or pharmacist your medical history, especially of:

  • liver problems
  • very high/low blood pressure
  • breathing problems (e.g., asthma)
  • depression
  • personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)

Precautions:

  • This drug may make you dizzy or drowsy.
  • Alcohol or marijuana (cannabis) can make you more dizzy or drowsy.
  • Do not drive, use machinery, or do anything that needs alertness until you can do it safely.
  • Avoid alcoholic beverages.
  • Talk to your doctor if you are using marijuana (cannabis).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

User Reviews:

41 Total User Reviews
Zaleplon Oral Read Reviews
Condition: Cronic Trouble Sleeping (21 Reviews):
Effectiveness(2.62)

Ease of Use(4.57)

Satisfaction(2.43)


Liver:
Zaleplon has not been implicated in causing serum enzyme elevations or clinically apparent liver injury.

Zaleplon Hepatotoxicity:
In multiple premarketing randomized controlled trials, zaleplon was not associated with an increased rate of serum enzyme elevations in comparison to placebo therapy, and no instance of clinically apparent liver injury was reported. Since its approval and widescale use, zaleplon has not been implicated in causing clinically apparent liver disease. Nevertheless, zaleplon is metabolized in the liver by the cytochrome P450 system (predominantly CYP 3A4) and can cause drug-drug interactions, although such interactions appear to be rare. Thus, zaleplon induced liver injury must be rare, if it occurs at all.

E Likelihood score: E (unlikely cause of clinically apparent liver injury).


Important Information:

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. If this happens to you, stop taking zaleplon and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

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

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid taking zaleplon with food or right after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medicine. Zaleplon can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how zaleplon will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Interactions:

Drug Interactions (334) Alcohol/Food Interactions (1) Disease Interactions (8)


What other drugs will affect Zaleplon?
Using zaleplon with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, other sleep medicine, a muscle relaxer, or medicine for anxiety or seizures. Other drugs may affect zaleplon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

A total of 334 drugs are known to interact with Zaleplon.

  • 24 major drug interactions
  • 297 moderate drug interactions
  • 13 minor drug interactions

Sonata (zaleplon)
Side Effects:
Zaleplon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.
RxList
Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking zaleplon and call your doctor right away.
Serious injury or death could occur if you walk or drive while you are not fully awake.
Call your doctor at once if you have:
  • anxiety, depression, aggression, agitation
  • memory problems, unusual thoughts or behavior
  • thoughts of hurting yourself
  • confusion, hallucinations (hearing or seeing things)
Common side effects may include:
  • day-time drowsiness, dizziness, "hangover" feeling
  • feeling light-headed
  • problems with coordination
  • numbness, tingling, or prickly feeling on your skin
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sonata (zaleplon)
Maximum Dosage:
Prescribers Digital Reference
Adults:20 mg/day PO at bedtime. Debilitated adult patients may require 10 mg/day PO.
Elderly10 mg/day PO at bedtime.
Adolescents:Safety and efficacy have not been established.
Children:Safety and efficacy have not been established.
Infants:Not indicated.

Sonata (zaleplon) (Rx)
Black Box Warnings:
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur; some of these events may result in serious injuries, including death; discontinue therapy immediately if a patient experiences a complex sleep behavior

Pediatric:
Appropriate studies have not been performed on the relationship of age to the effects of zaleplon in the pediatric population.

Safety and efficacy have not been established.

Geriatric:
Appropriate studies performed to date have not demonstrated geriatric specific problems that would limit the usefulness of zaleplon in the elderly.

Breastfeeding:

Summary of Use during Lactation:
Because of the low levels of zaleplon in breastmilk and its short half-life, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.

Drug Levels:? Maternal Levels. Five nursing mothers who were at least 14 days postpartum were given a single oral dose of zaleplon 10 mg. The peak milk level averaged 14 mcg/L at 1.2 hours after the dose. The mean half-life in milk was 1.1 hours. Using the peak milk level data from this study, an exclusively breastfed infant would receive an estimated maximum of 2.1 mcg/kg daily with this maternal dosage regimen or about 1.4% of the maternal weight-adjusted dosage.

Alternate Drugs to Consider:

  
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