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Zaleplon is a sedative that is used to treat insomnia. zaleplon causes relaxation to help you fall asleep and stay asleep.
Zaleplon may also be used for purposes not listed in this medication guide.
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.
You should not use zaleplon if you are allergic to it, or if you have ever taken sleep medicine and engaged in activity you later don't remember.
Zaleplon is not approved for use by anyone younger than 18 years old.
Tell your doctor if you have ever had:
liver or kidney disease;
a breathing disorder;
depression, mental illness, or suicidal thoughts; or
drug or alcohol addiction.
You should not take zaleplon if you are pregnant.
You should not breastfeed while using zaleplon.
The sedative effects of zaleplon may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking zaleplon.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Zaleplon may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away zaleplon is against the law.
Zaleplon will make you fall asleep. Never take this medication during your normal waking hours, unless you have several hours to dedicate to sleeping.
Zaleplon is for short-term use only. Do not take zaleplon for longer than 5 weeks without your doctor's advice.
Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse.
Do not stop using zaleplon suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Insomnia symptoms may also return after you stop taking zaleplon, and may be even worse than before. Tell your doctor if you still have worsened insomnia after the first few nights without taking zaleplon.
Since zaleplon is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medication if you do not have several hours to sleep before being active again.
Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zaleplon can be fatal, especially when it is taken together with other medications that can cause drowsiness.
Overdose symptoms may include severe drowsiness, confusion, loss of coordination, severe muscle weakness, weak or shallow breathing, fainting.
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.
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.
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; or
confusion, hallucinations (hearing or seeing things).
Common side effects may include:
day-time drowsiness, dizziness, "hangover" feeling;
feeling light-headed;
problems with coordination; or
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.
Usual Adult Dose for Insomnia:
10 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 20 mg/day
Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.
Use: Short-term treatment of insomnia
Usual Geriatric Dose for Insomnia:
5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 10 mg/day
Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.
Use: Short-term treatment of insomnia
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.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Zaleplon (www.drugs.com/mtm/zaleplon.html).
More frequently reported side effects include: amnesia and dizziness. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to zaleplon: oral capsule
Along with its needed effects, zaleplon 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 while taking zaleplon:
Less common
Rare
Get emergency help immediately if any of the following symptoms of overdose occur while taking zaleplon:
Symptoms of overdose
Some side effects of zaleplon 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
Less common
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
For Healthcare Professionals
Applies to zaleplon: oral capsule
GeneralThe most commonly reported side effects included headache, dizziness, nausea, asthenia, and somnolence.
Nervous systemVery common (10% or more): Headache (up to 42%)
Common (1% to 10%): Amnesia, difficulty concentrating, dizziness, hypertonia, hypesthesia, migraine, paresthesia, parosmia, somnolence, taste perversion, tremor, vertigo
Uncommon (0.1% to 1%): Abnormal gait, ataxia, hyperesthesia, hyperkinesia, hypotonia, incoordination, neuralgia, nystagmus
Rare (less than 0.1%): Central nervous system (CNS) stimulation, cerebral ischemia, decreased reflexes, dysarthria, dystonia, facial paralysis, hypokinesia, increased reflexes, myoclonus, neuropathy, slurred speech, stupor, taste loss, visual field defect
PsychiatricCommon (1% to 10%): Abnormal thinking, anxiety, confusion, depersonalization, depression, hallucinations, nervousness
Uncommon (0.1% to 1%): Agitation, apathy, decreased libido, emotional lability, euphoria, insomnia
Rare (less than 0.1%): Bruxism, delusions, hostility, psychomotor retardation, sleep talking, sleep walking
Postmarketing reports: Nightmares
GastrointestinalCommon (1% to 10%): Abdominal pain, colitis, constipation, dry mouth, dyspepsia, nausea
Uncommon (0.1% to 1%): Circumoral paresthesia, eructation, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, glossitis, mouth ulceration, rectal hemorrhage, stomatitis
Rare (less than 0.1%): Aphthous stomatitis, cardiospasm, cheilitis, duodenal ulcer, dysphagia, enteritis, gum hemorrhage, increased salivation, intestinal obstruction, peptic ulcer, tongue discoloration, tongue edema, ulcerative stomatitis
OtherCommon (1% to 10%): Asthenia, ear pain, fever, hyperacusis, malaise
Uncommon (0.1% to 1%): Chills, face edema, hangover effect, substernal chest pain, tinnitus
Rare (less than 0.1%): Deafness, labyrinthitis
MusculoskeletalCommon (1% to 10%): Arthralgia, arthritis, back pain, myalgia
Uncommon (0.1% to 1%): Arthrosis, bursitis, joint disorder, joint pain, joint stiffness, joint swelling, neck rigidity, myasthenia, tenosynovitis
Rare (less than 0.1%): Myositis, osteoporosis, trismus
DermatologicCommon (1% to 10%): Photosensitivity reaction, pruritus, rash
Uncommon (0.1% to 1%): Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, maculopapular rash, skin hypertrophy, sweating, urticaria, vesiculobullous rash
Rare (less than 0.1%): Melanosis, psoriasis, purpura, pustular rash, skin discoloration
OcularCommon (1% to 10%): Abnormal vision, conjunctivitis, eye pain
Uncommon (0.1% to 1%): Diplopia, dry eyes, photophobia, watery eyes
Rare (less than 0.1%): Abnormality of accommodation, blepharitis, cataract specified, corneal erosion, eye hemorrhage, glaucoma, ptosis, retinal detachment
CardiovascularCommon (1% to 10%): Chest pain, peripheral edema
Uncommon (0.1% to 1%): Angina pectoris, bundle branch block, edema, generalized edema, hypertension, hypotension, palpitation, tachycardia, vasodilation, ventricular extrasystoles
Rare (less than 0.1%): Bigeminy, cyanosis, pericardial effusion, postural hypotension, sinus bradycardia, thrombophlebitis, ventricular tachycardia
RespiratoryCommon (1% to 10%): Bronchitis, epistaxis
Uncommon (0.1% to 1%): Asthma, dyspnea, laryngitis, pneumonia, snoring, voice alteration
Rare (less than 0.1%): Apnea, hiccup, hyperventilation, increased sputum, pleural effusion, pulmonary embolus
GenitourinaryCommon (1% to 10%): Dysmenorrhea
Uncommon (0.1% to 1%): Bladder pain, breast pain, cystitis, decreased urine stream, dysuria, hematuria, impotence, menorrhagia, metrorrhagia, urinary frequency, urinary incontinence, urinary urgency, vaginitis
Rare (less than 0.1%): Albuminuria, delayed menstrual period, leukorrhea, menopause, urethritis, urinary retention, vaginal hemorrhage
MetabolicCommon (1% to 10%): Anorexia
Uncommon (0.1% to 1%): Gout, hypercholesteremia, increased appetite, thirst, weight gain
Rare (less than 0.1%): Diabetes mellitus, hyperglycemia, hyperuricemia, hypoglycemia, hypoglycemic reaction, ketosis, lactose intolerance, weight loss
HematologicUncommon (0.1% to 1%): Anemia, lymphadenopathy
Rare (less than 0.1%): Eosinophilia, leukocytosis, lymphocytosis
RenalUncommon (0.1% to 1%): Kidney calculus, kidney pain
HepaticRare (less than 0.1%): Abnormal liver function tests, bilirubinemia, biliary pain, cholelithiasis, increased ALT, increased AST
EndocrineRare (less than 0.1%): Goiter, hypothyroidism
HypersensitivityPostmarketing reports: Anaphylactic/anaphylactoid reactions, severe anaphylactic/anaphylactoid reactions
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Zaleplon (www.drugs.com/mtm/zaleplon.html).
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