Tablet and Capsule
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Zaleplon

Zaleplon

Brand Name: -
Dosage Form: 5 mg, 10 mg Capsules
Package: 30 Capsules
Drug Group: Pyrazolopyrimidine, nonbenzodiazepine hypnotic
Use: Insomnia (Short-term Use)

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Uses
Zaleplon has been approved for the short-term treatment of insomnia in adults, including elderly patients. Zaleplon is not a sleep maintenance drug. Rather it remains at its binding site for only a short time, and is rapidly eliminated after sleep is initiated so the patient's natural sleep processes can take over.
How to take
  • Take this medicine either right before bedtime, when you are ready to go to sleep. 
  • Store at room temperature away from moisture, heat, and light.
  • It is better to take this medicine on an empty stomach 
  • Do not take your medicine more often than directed. 
  • If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Dosage and administration

Oral dosage form (capsules):
For the treatment of insomnia (trouble in sleeping):
Adults: 10 milligrams (mg) once a day at bedtime
Older adults: 5 mg once a day at bedtime
Children up to 18 years of age: Use and dose must be determined by doctor.

There are different doses for people who have mild to moderate liver problems:
Mild to moderate liver problems: Take one 5 mg capsule.

Note
It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly. Swallow the capsule(s) with a small glass of water

Warning & Precautions

Before taking

  • Tell your doctor if you have ever had any unusual or allergic reaction to zaleplon
  • Other medicines: If you take other medicines such as:
Alcohol (with chronic use) or
Central nervous system (CNS) depressants
Cimetidine
Hepatic cytochrome P450 enzyme inducers
  • Other medical problems: if you have any other medical problems, especially:
Alcohol abuse (or history of)
Drug abuse or dependence (or history of)
Respiratory disease
Mental depression
Hepatic function impairment

Contraindications
  • Do not take zaleplon:
Hypersensitivity to the active substance or to any of the excipients
Severe hepatic impairment
Severe renal impairment
Sleep apnoea syndrome
Myasthenia gravis (very weak or tired muscles)
Severe respiratory insufficiency
Children (under 18 years of age)
If your sleeplessness persists or worsens after a short course of Zaleplon treatment contact your doctor.
  • There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event. If you experience these events, contact your doctor immediately.
  • This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Drug Interactions
Check with your doctor before taking alcohol or any of the medicines such as Central nervous system (Imipramine, diphenhydramine, thioridazine), or hepatic cytochrome P450 enzyme inducers (Carbamazepine, Phenytoin, Rifampin, Phenobarbital) while you are using this medicine.
Pregnancy and Breastfeeding
FDA pregnancy category C. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Zaleplon should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy and breast-feeding.

Side/Adverse effects
If any of the following side effects occur while taking zaleplon, check with your doctor immediately:

Less common:
  • Anxiety
  • Blurred or double vision
  • Not feeling like oneself

Rare
  • Nosebleed
  • Seeing, hearing, smelling, or feeling things that are not there

If any of the following symptoms of overdose occur while taking zaleplon, get emergency help immediately:

More common:
  • Dizziness
  • Headache
  • Muscle pain
  • Nausea

Less common:
  • Abdominal pain
  • Burning, prickling, or tingling sensation
  • Constipation
  • Cough
  • Difficulty concentrating
  • Drowsiness
  • Dryness of mouth
  • Excess muscle tone
  • Eye pain
  • Fever
  • Heartburn, indigestion, or acid stomach
  • Itching
  • Itching or burning eyes
  • Joint stiffness and/or pain
  • Memory loss
  • Menstrual pain
  • Mental depression
  • Nervousness
  • Sensitive hearing
  • Severe headache
  • Shortness of breath
  • Skin rash
  • Tightness in chest
  • Trembling or shaking
  • Troubled breathing
  • Unusual weakness or tiredness
  • Wheezing

Rare:
  • Loss of appetite
  • Back pain 
  • Chest pain
  • Ear pain
  • Numbness
  • General feeling of discomfort or illness
  • Sense of smell difficulty
  • Swelling of fingers, hands, arms, legs, ankles and feet; bloating or swelling of face; rapid weight gain,
  • Increased sensitivity of skin and eyes to sunlight; blisters; skin rash; redness; burning sensation; severe sunburn


Storage
  • Keep out of the reach of children.
  • Store this medicine below 30 C, away from heat and direct light.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.