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Sonata / Zaleplon

Zaleplon (marketed under the brand names Sonata, Starnoc, and Andante) is a sedative-hypnotic affecting chemicals in the brain that may be unbalanced in people with sleeping problems. This medicine causes relaxation to help you fall asleep and stay asleep. Zaleplon is almost entirely used for the management/treatment of insomnia. It is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class. 

Sonata (US) is manufactured by King Pharmaceuticals of Bristol, TN. Gedeon Richter Plc. manufactures Zaleplon under the brand name Andante. Starnoc has been discontinued in Canada but can be manufactured if a prescription is brought to a compounding pharmacy. It is prescribed rarely in the United Kingdom, with zopiclone being the preferred Z-drug by the National Health Service (NHS).

Zaleplon may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Zaleplon?

To make sure Zaleplon is safe for you, tell your doctor if you have ever been addicted to drugs or alcohol.

Zaleplon may be habit-forming. Keep the medication in a place where others cannot get to it. MISUSE OF THIS MEDICATION CAN CAUSE ADDICTION OR OVERDOSE, especially in a child or other person using the medicine without a prescription. Selling or giving away Zaleplon is against the law.

Medical uses

Zaleplon is effective in the management/treatment of insomnia, primarily characterized by difficulty falling asleep. Due to its ultrashort elimination half-life, Zaleplon may not be effective in reducing premature awakenings.

It may result in an impaired ability to drive the next day, though it has proven promising when compared to other sedative/hypnotics and next-day residual sedation.It may have advantages over benzodiazepines with fewer adverse effects.

Neither Zaleplon, nor any nonbenzodiazepine hypnotic class medication should be combined with alcohol, as both modulate GABAAreceptor sites, and in a synergistic manner increase the chances of fatal respiratory depression and asphyxiation from vomiting.

Zaleplon

 

 

What should I discuss with my healthcare provider before taking Zaleplon?

You should not use this medicine if you are allergic to Zaleplon.

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

  • liver or kidney disease;
  • sleep apnea (breathing stops while you are asleep);
  • lung disease (asthma, bronchitis, emphysema, COPD) or other breathing problems;
  • a history of depression, mental illness, or suicidal thoughts; or
  • a history of drug or alcohol addiction.

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

It is not known whether Zaleplon passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

The sedative effects of Zaleplon may be stronger in older adults. Dizziness or severe drowsiness can cause falls or other accidents.

 

How should I take Zaleplon?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Zaleplon will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 4 hours to dedicate to sleeping.

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

Avoid taking Zaleplon within 1 hour after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medication.

Zaleplon is for short-term use only. Do not take Zaleplon for longer than 2 weeks without your doctor's advice.

Call your doctor if your insomnia symptoms do not improve, or if they get worse after using Zaleplon for 7 to 10 nights in a row

Zaleplon may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF THIS MEDICATION CAN CAUSE ADDICTION OR OVERDOSE, especially in a child or other person using the medicine without a prescription. Selling or giving away Zaleplon is against the law.

Do not stop using Zaleplon suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Zaleplon is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since Zaleplon is usually taken as needed, you may not be on a dosing schedule. Never take this medication if you do not have at least 4 hours to sleep before being active again. Do not take extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, confusion, loss of coordination, limp muscles, weak or shallow breathing, fainting.

What should I avoid while taking Zaleplon?

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 this medication 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.

Do not drink alcohol while you are taking Zaleplon. It can increase some of the side effects of Zaleplon, including drowsiness.

Do not take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).

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 at least 4 hours of sleep after taking Zaleplon.

Possible Zaleplon side effects

The side effects of Zaleplon are similar to the side effects of benzodiazepines, although with less next-day sedation,and in two studies Zaleplon use was found to not cause an increase in traffic accidents, as compared to other hypnotics currently on the market.

 

Available data cannot provide a reliable estimate of the incidence of dependence during treatment at recommended doses of Zaleplon (typically 5–20 mg before bed). Other sedative/hypnotics have been associated with various signs and symptoms of a withdrawal syndrome, following abrupt discontinuation, ranging from mild dysphoria and insomnia to more serious cases that include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. Following abrupt cessation, the seizure threshold is further lowered, wherein coma and death are possible outcomes if untreated.

Some evidence suggests zaleplon is not as chemically reinforcing and exhibits far fewer rebound effects when compared with other nonbenzodiazepines, or Z-drugs

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.

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

  • aggression, agitation, changes in behavior;
  • anxiety, nervous feeling, depression, confusion, hallucinations;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • thoughts of hurting yourself; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • problems with memory or coordination;
  • drowsiness, dizziness;
  • numbness or tingling;
  • headache;
  • upset stomach, constipation;
  • dry mouth;
  • back pain, chest pain;
  • joint or muscle pain; or
  • mild itching or rash.

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.

 

Zaleplon dosing information

Usual Adult Dose for Insomnia:

5 to 20 mg orally immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep.

Doses above 20 mg have not been adequately evaluated and are not recommended.

Usual Geriatric Dose for Insomnia:

Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Zaleplon. Doses over 10 mg are not recommended.

What other drugs will affect Zaleplon?

Taking this medicine with other drugs that make you sleepy can worsen these effects. Ask your doctor before taking Zaleplon with any other sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with Zaleplon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Zaleplon Side Effects

 

More frequently reported side effects include dizziness and amnesia. See below for a comprehensive list of adverse effects.

Recreational use

Zaleplon has the potential to be a drug of abuse, and has been found to have an abuse potential similar to benzodiazepine and benzodiazepine-like hypnotics.The mind- and judgment-altering effects of Zaleplon are similar to those of many other benzodiazepines, but the fast-acting nature and short half-life of the chemical mean high doses set on much more quickly and last for short periods of time (usually from 45 to 60 minutes).

Some individuals use a different delivery method than prescribed, such as insufflation, to induce effects faster.

 

 

Sonata 10-mg capsules

Insufflation of the drug causes loss of yield, as Zaleplon is not entirely water-soluble, and may cause damage to the nasal passageways and sinuses.

A common effect of zaleplon abuse is the occurrence of (typically short-lived) hallucinations. Fewer visual and auditory hallucinations/disruptions with the use of Zaleplon than with other drugs in the nonbenzodiazepine class (e.g. Zolpidem and the “Ambien Walrus”).Anterograde amnesia can occur and can cause one to lose track of the amount of Zaleplon already ingested, prompting one to ingest more than originally planned. However, continuous ingestion is extremely unlikely precisely because of Zaleplon's quick onset of action.

The combination of alcohol and Zaleplon can result in fatal respiratory depression and asphyxiation from vomiting.

Aviation use

The FAA allows Zaleplon with a 6-hour wait period and no more than twice a week.

Military use

The United States Air Force uses zaleplon as one of the hypnotics approved as a "no-go pill" to help aviators and special-duty personnel sleep in support of mission readiness (with a four-hour restriction on subsequent flight operation). "Ground tests" are required prior to authorization being issued to use the medication in an operational situation. (The other hypnotics used as "no-go pills" are Temazepam and Zolpidem, which both have longer mandatory recovery periods.

 

 

 

 



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