as other cognitive and/or neuropsychiatric adverse reactions.lemborexantSerious - Use Alternative (1)lemborexant, zaleplon. Either increases effects of the other by sedation. Avoid or Use Alternate Drug. Use of lemborexant with other drugs to treat insomnia is not recommended.letermovirMonitor Closely (1)letermovir increases levels of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.levoketoconazoleMonitor Closely (1)levoketoconazole will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.lumefantrineMinor (1)lumefantrine will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.lurasidoneMonitor Closely (1)lurasidone, zaleplon. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.marijuanaMinor (1)marijuana will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.metoclopramide intranasalSerious - Use Alternative (1)zaleplon, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.metronidazoleMinor (1)metronidazole will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.miconazole vaginalMinor (1)miconazole vaginal will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.midazolam intranasalMonitor Closely (1)midazolam intranasal, zaleplon. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.nefazodoneMonitor Closely (1)nefazodone will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.nelfinavirMinor (1)nelfinavir will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nevirapineMinor (1)nevirapine will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nifedipineMinor (1)nifedipine will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.nilotinibMinor (1)nilotinib will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.oliceridineMonitor Closely (1)oliceridine, zaleplon. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.olopatadine intranasalSerious - Use Alternative (1)zaleplon and olopatadine intranasal both increase sedation. Avoid or Use Alternate Drug. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment. oxcarbazepineMinor (1)oxcarbazepine will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.oxycodoneSerious - Use Alternative (1)zaleplon and oxycodone both increase sedation. Avoid or Use Alternate Drug. Additive CNS depression may lead to hypotension, profound sedation, respiratory depression, or comapentobarbitalMinor (1)pentobarbital will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.phenobarbitalMinor (1)phenobarbital will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.phenytoinMinor (1)phenytoin will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.posaconazoleMinor (1)posaconazole will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.pregabalinMonitor Closely (1)pregabalin, zaleplon. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.primidoneMinor (1)primidone will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.quinupristin/dalfopristinMinor (1)quinupristin/dalfopristin will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.remimazolamMonitor Closely (1)remimazolam, zaleplon. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.ribociclibMonitor Closely (1)ribociclib will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.rifabutinMonitor Closely (1)rifabutin will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.rifampinMonitor Closely (1)rifampin will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.rifapentineMinor (1)rifapentine will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.ritonavirMinor (1)ritonavir will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.rufinamideMinor (1)rufinamide will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.secobarbitalMinor (1)secobarbital will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.selinexorSerious - Use Alternative (1)selinexor, zaleplon. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.sodium oxybateContraindicated (1)zaleplon, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration with alcohol or sedative hypnotics are contraindicated because of additive CNS depression.St John's WortMonitor Closely (1)St John's Wort will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.sufentanil SLSerious - Use Alternative (1)sufentanil SL, zaleplon. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.topiramateMinor (1)topiramate will decrease the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.valerianSerious - Use Alternative (1)valerian and zaleplon both increase sedation. Avoid or Use Alternate Drug.verapamilMinor (1)verapamil will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.voriconazoleMinor (1)voriconazole will increase the level or effect of zaleplon by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. >10% Headache (38%) 1-10% Dizziness (7-9%) Nausea (6-8%) Abdominal pain (6%) Weakness (5-7%) Dysmenorrhea (3-4%) Eye pain (3-4%) Amnesia (2-4%) Parasthesia (3%) Tremor (2%) <1% Fever Photosensitivity Anorexia Colitis Periphipheral edema Amnesia Anxiety Depersonalization Hallucination Hypesthesia Vertigo Epistaxis Abnl vision Ear pain Hyperacusis Parosmia Postmarketing Reports Anaphylactic/anaphylactoid reactions, including severe reactions Nightmares 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 behaviorContraindications Hypersensitivity Patients who have experienced complex sleep behaviors after taking zaleplon Cautions Use caution in mild-to-moderate hepatic impairment; not recommended with severe hepatic impairment Amnesia may occur Use caution in patients respiratory diseases or patients experiencing clinical depression (condition may worsen) Therapy can cause drowsiness and a decreased level of consciousness; patients, particularly the elderly, are at higher risk of falls In primarily depressed patients treated with sedative-hypnotics, worsening of depression, including suicidal thoughts and actions (including completed suicides), reported Post-marketing reports have shown complex sleep behaviors may occur with drug alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants Dosage adjustments of drug and of other concomitant CNS depressants may be necessary when drug administered with such agents because of potentially additive effects Use with other sedative-hypnotics at bedtime or the middle of the night not recommended Risk of next-day psychomotor impairment, including impaired driving, is increased if drug taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than recommended dose taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase blood levels of zaleplon; warn patients against driving and other activities requiring complete mental alertness if drug taken in these circumstances Signs and symptoms associated with withdrawal from other CNS depressant drugs reported following rapid dose decrease or abrupt discontinuation of use of sedative/hypnotics Pregnancy Category: C Lactation: small amount secreted in breast milk, not recommendedPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Pyrazolopyrimidine; GABA-BZD receptor complex agonist Pharmacokinetics Half-life elimination: 1 hr Duration: Shorter than zolpidem Peak Plasma Time: 1 hr Bioavailability: 30% (undergoes extensive presystemic metabolism) Protein Bound: 45-75% Vd: 1.4 L/kg Metabolism: mostly by aldehyde oxidase; some by CYP3A4 Metabolites: Inactive Total Body Clearance: 3 L/hr/kg Excretion: urine 70%; feces 17% BRAND FORM. UNIT PRICE PILL IMAGE zaleplon oral- 10 mg capsulezaleplon oral- 5 mg capsulezaleplon oral- 10 mg capsulezaleplon oral- 5 mg capsulezaleplon oral- 10 mg capsulezaleplon oral- 10 mg capsulezaleplon oral- 5 mg capsulezaleplon oral- 5 mg capsuleCopyright © 2010 First DataBank, Inc.Print Patient Educationzaleplon oral ZALEPLON - ORAL (ZAL-e-plon) COMMON BRAND NAME(S): Sonata WARNING: Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous (possibly fatal) to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. You should not take this medication or similar medications (such as eszopiclone, zolpidem) if you have this reaction to the medication. 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. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking zaleplon and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth as directed by your doctor. Zaleplon works very quickly, so it is important to take it just before or when you get into bed. Your doctor will work with you to find the smallest dose that works for you.Zaleplon should not be used for naps. Do not take a dose of this drug unless you have time for a full night's sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss and may have trouble safely doing any activity that requires alertness, such as driving or operating machinery.You should not eat a very heavy/high-fat meal within 2 hours before taking this medication since doing so may prevent the drug from working properly.Th dosage is based on your medical condition, age, and response to treatment. Since this medication is usually prescribed for a short time, your doctor will tell you when to stop taking it or when to cut back.You may feel anxious or have trouble falling asleep in the first day or two after stopping this medication (rebound insomnia). Contact your doctor if you continue to have trouble falling asleep several days after stopping zaleplon.If you suddenly stop using this medication, you may have withdrawal symptoms (such as unusual depressed/anxious mood, stomach/muscle cramps, vomiting, sweating, shakiness, or seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used zaleplon for a long time (more than a few weeks) or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of