Pronunciation:

ZAL-e-plon

Brand Names:

• Sonata

Dosage Forms:

• Capsule

Warnings:

Complex sleep behaviors including sleep-walking, sleep driving, and engaging in other activities while not fully awake may occur following use of zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior .

Classifications:

Therapeutic—

Nonbarbiturate Hypnotic

Uses of This Medicine:

Zaleplon is used to treat insomnia (trouble sleeping). It belongs to the group of medicines called central nervous system (CNS) depressants, which slows down the nervous system. Zaleplon will help you get to sleep faster and sleep throughout the night. In most cases, sleep medicines should only be used for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric specific problems that would limit the usefulness of zaleplon in the elderly. However, confusion, dizziness, and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zolpidem.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Calcium Oxybate
• Magnesium Oxybate
• Potassium Oxybate
• Sodium Oxybate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Alfentanil
• Alprazolam
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butorphanol
• Cannabidiol
• Cannabis
• Carbinoxamine
• Ceritinib
• Cetirizine
• Clarithromycin
• Clobazam
• Clonazepam
• Cobicistat
• Codeine
• Conivaptan
• Daridorexant
• Dexmedetomidine
• Dihydrocodeine
• Doxylamine
• Esketamine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Flumazenil
• Fosnetupitant
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Itraconazole
• Ketamine
• Ketoconazole
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Mavacamten
• Meclizine
• Meperidine
• Methadone
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Netupitant
• Olanzapine
• Omaveloxolone
• Oxycodone
• Oxymorphone
• Pentazocine
• Periciazine
• Phenobarbital
• Pregabalin
• Primidone
• Propofol
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Sufentanil
• Tapentadol
• Topiramate
• Tramadol
• Trazodone
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine
• Rifampin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse or dependence, history of—Dependence on zaleplon may develop.

• Aspirin sensitivity or
• Asthma—This medicine contains tartrazine, which may increase risk for more serious side effects.

• Depression, or history of or
• Lung disease (eg, COPD) or other breathing problems or
• Mental illness, history of or
• Sleep apnea (breathing problems during sleep)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take zaleplon just before going to bed or when you have trouble falling asleep. This medicine works very quickly to put you to sleep.

Do not take this medicine when your schedule does not permit you to get a full night's sleep (about 7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Take this medicine on an empty stomach.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For the treatment of insomnia:
    • Adults—5 or 10 milligrams (mg) once a day at bedtime. Your doctor may adjust your dose as needed and tolerated. However, do not take more than 20 mg per day.
    • Older adults—5 mg once a day at bedtime.
    • Children—Use and dose must be determined by doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use this medicine only when you cannot sleep. You do not need to keep a schedule for taking it.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you think you need to take zaleplon for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

Zaleplon may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally, which may lead to falls. Even though zaleplon is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you develop any unusual and strange thoughts or behavior while using zaleplon, be sure to discuss it with your doctor. Some changes that have occurred in people using this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, hallucinations (seeing, hearing, smelling, or feeling things that are not there), and unusual excitement, nervousness, or irritability.

This medicine may cause you to do things while you are still asleep that you may not remember the next morning. It is possible you could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if you learn that any of these has happened.

Do not change your dose or stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.

After taking zaleplon for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zaleplon or taking alcohol or other CNS depressants with zaleplon may lead to breathing problems and unconsciousness. Some signs of an overdose include: clumsiness or unsteadiness, confusion, severe drowsiness, low blood pressure, unusual dullness or feeling sluggish, and troubled breathing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Anxiety

blurred or double vision

chest pain

confusion about identity, place, and time

discouragement

false or unusual sense of well-being

fast, irregular, pounding, or racing heartbeat or pulse

feeling sad or empty

fever

general feeling of discomfort or illness

hives, skin rash

irritability

lack of appetite

lightheadedness

loss of interest or pleasure

not feeling like oneself

shakiness and unsteady walk

tightness in the chest

trouble concentrating

trouble sleeping

troubled breathing

unsteadiness, trembling, or other problems with muscle control or coordination

unusual weakness or tiredness

Rare

Anxiety

attack, assault, or force

black, tarry stools

bladder pain

bloody or cloudy urine

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in walking and balance

chills

cold sweats

cough

crying

decreased awareness or responsiveness

deep or fast breathing with dizziness

delusions of persecution, mistrust, suspiciousness, or combativeness

difficult, burning, or painful urination

difficulty swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

dry mouth

fainting

false beliefs that cannot be changed by facts

feeling of unreality

fever

frequent urge to urinate

irregular heartbeat

irritability

itching skin

lack of feeling or emotion

light-colored stools

lower back or side pain

nausea

numbness of the feet, hands, and around the mouth

pale skin

poor insight and judgment

problems with memory or speech

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

quick to react or overreact emotionally

rapidly changing moods

restlessness

seeing, hearing, or feeling things that are not there

sense of detachment from self or body

severe sleepiness

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

swollen glands

thoughts of killing oneself or changes in behavior

tightness in the chest

trouble recognizing objects

trouble thinking and planning

trouble walking

troubled breathing with exertion

uncaring

unusual bleeding or bruising

vomiting

yellow eyes or skin

unease or dissatisfaction with life

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Confusion

clumsiness or unsteadiness, severe

dizziness or fainting

drowsiness, severe

weak muscle tone

troubled breathing

unusual dullness or feeling sluggish

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness

headache

muscle aches

sleepiness or unusual drowsiness

stuffy or runny nose

Less common

Back pain

being forgetful

belching

body aches or pain

congestion

diarrhea

difficulty having a bowel movement

difficulty with moving

double vision

feeling of constant movement of self or surroundings

heartburn

hoarseness

indigestion

longer or heavier menstrual periods

loss of memory

muscle pain or stiffness

pain or tenderness around the eyes and cheekbones

seeing double

sensation of spinning

stomach discomfort

tender, swollen glands in the neck

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

voice changes

Rare

Bad, unusual, or unpleasant (after) taste

blemishes on the skin

blindness

blurred vision

breast pain

change in near or distance vision

change in taste

changes in patterns and rhythms of speech

decreased interest in sexual intercourse

difficulty in focusing the eyes

eye pain

feeling of warmth

frequent urge to defecate

inability to have or keep an erection

increased appetite

increased sensitivity of the skin to sunlight

increased sweating

itching of the vagina or genital area

lack or loss of strength

loss in sexual ability, desire, drive, or performance

pain during sexual intercourse

paleness of the skin

pimples

redness of the face, neck, arms, and occasionally, upper chest

redness or other discoloration of the skin

severe sunburn

slurred speech

stomach upset

straining while passing stool

tearing

thick, white vaginal discharge with no odor or with a mild odor

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.