Zaleplon (sonata) is a rapid-acting hypnotic drug that interacts with the benzodiazepines GABA receptor complex. It is used for the short-term treatment of insomnia (up to 30 days)
Zaleplon Dose in Adults
Dose in the treatment of Insomnia:
- The usual dose is 10 mg orally immediately before bedtime (range: 5 - 20 mg)
- Lean patients may be prescribed an initial dose of 5 mg.
- The duration of treatment depends on the response to treatment but may be used for up to 5 weeks.
Dose in Debilitated patients:
- 5 mg orally immediately before bedtime to the maximum dose of 10 mg/day.
Dose in patients on Concomitant cimetidine therapy:
- 5 mg initially.
Zaleplon Dose in Children
Not recommended.
Zaleplon pregnancy Risk Factor: C
- Although teratogenic effects have not yet been identified, it has been shown to have adverse fetal outcomes, including stillbirth, mortality after birth, and reduced growth and physical development.
- It is best to avoid it during pregnancy, according to the manufacturer.
Use Zaleplon while breastfeeding
- Breastmilk contains Zaleplon. It is recommended that you avoid it while breastfeeding.
Zaleplon Dose in Renal Disease:
Dose adjustment in the dose is not necessary for patients with renal disease.
Zaleplon Dose in Liver Disease:
- Mild to moderate impairment:
- 5 mg immediately before bedtime
- Severe impairment:
- Avoid its use.
Common Side Effects of Zaleplon Include:
- Central nervous system:
- Headache
Less Common Side Effects of Zaleplon Include:
- Cardiovascular:
- Chest Pain
- Peripheral Edema
- Central Nervous System:
- Dizziness
- Drowsiness
- Amnesia
- Paresthesia
- Altered Sense Of Smell
- Depersonalization
- Hyperacusis
- Hypoesthesia
- Malaise
- Abnormality In Thinking
- Anxiety
- Depression
- Migraine
- Nervousness
- Hypertonia
- Confusion
- Hallucination
- Vertigo
- Dermatologic:
- Pruritus
- Skin Rash
- Skin Photosensitivity
- Gastrointestinal:
- Nausea
- Abdominal Pain
- Anorexia
- Constipation
- Dysgeusia
- Dyspepsia
- Xerostomia
- Colitis
- Genitourinary:
- Dysmenorrhea
- Neuromuscular & Skeletal:
- Weakness
- Tremor
- Arthralgia
- Arthritis
- Back Pain
- Myalgia
- Ophthalmic:
- Eye Pain
- Visual Disturbance
- Conjunctivitis
- Otic:
- Otalgia
- Respiratory:
- Bronchitis
- Epistaxis
- Miscellaneous:
- Fever
Contraindication to Zaleplon Include:
- Allergy reactions to zaleplon and any component of this formulation
Warnings and Precautions
- Abnormal behavior/thinking:
- The use of sedatives or hypnotics can lead to behavioral changes such as abnormal thinking, aggression, aggression, agitation and bizarre behavior.
- Before treatment can be initiated, patients must first be assessed for unrecognized mental disorders.
- Depression in the CNS:
- It can cause impairment of higher mental functions.
- It should be avoided by drivers and operators of heavy machinery.
- Patients who take concomitant benzodiazepines and other CNS depressant drugs are more likely to experience a CNS depressant effect.
- Hypersensitivity reactions
- It has been associated with allergic reactions such as anaphylaxis or angioedema.
- If such reactions occur, patients should not be administered any further medication.
- Activities that are sleep-related:
- Sleep-related hazardous activities are at greater risk. It has been reported that there are increased risks associated with sleep-related hazardous activities, such as driving, sleeping, eating, and cooking.
- Patients who are taking other CNS depressants drugs or drinking alcohol are at greater risk.
- Patients who have reported any sleep-related events must stop receiving treatment.
- Depression
- Patients with depression should use it with caution.
- It has been reported that there is a risk of suicide and suicidal ideation.
- It is important to use the smallest dose possible for the shortest time.
- To avoid accidental overdose, the prescription should only be given for the lowest possible dose.
- Use of drugs:
- Patients who have a history of drug dependence, benzodiazepine abuse or benzodiazepine-like addiction should be cautious about taking the drug.
- Hepatic impairment
- Patients suffering from liver disease should be aware that the drug may require adjustment and must be used with caution.
- Patients with severe hepatic impairment should avoid it.
- Respiratory disease
- Patients suffering from respiratory impairment such as COPD or sleep apnea should be cautious about taking the drug.
|
Alcohol (Ethyl) |
CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). |
|
Alizapride |
May enhance the CNS depressant effect of CNS Depressants. |
|
Brexanolone |
CNS Depressants may enhance the CNS depressant effect of Brexanolone. |
|
Brimonidine (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
|
Bromopride |
May enhance the CNS depressant effect of CNS Depressants. |
|
Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Cannabis |
May enhance the CNS depressant effect of CNS Depressants. |
|
Chlorphenesin Carbamate |
May enhance the adverse/toxic effect of CNS Depressants. |
|
CNS Depressants |
May enhance the adverse/toxic effect of other CNS Depressants. |
|
Dimethindene (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
|
Doxylamine |
May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. |
|
Dronabinol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Esketamine |
May enhance the CNS depressant effect of CNS Depressants. |
|
HydrOXYzine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Kava Kava |
May enhance the adverse/toxic effect of CNS Depressants. |
|
Lofexidine |
May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. |
|
Magnesium Sulfate |
May enhance the CNS depressant effect of CNS Depressants. |
|
Melatonin |
May enhance the sedative effect of Hypnotics (Nonbenzodiazepine). |
|
MetyroSINE |
CNS Depressants may enhance the sedative effect of MetyroSINE. |
|
Minocycline |
May enhance the CNS depressant effect of CNS Depressants. |
|
Mirtazapine |
CNS Depressants may enhance the CNS depressant effect of Mirtazapine. |
|
Nabilone |
May enhance the CNS depressant effect of CNS Depressants. |
|
Piribedil |
CNS Depressants may enhance the CNS depressant effect of Piribedil. |
|
Pramipexole |
CNS Depressants may enhance the sedative effect of Pramipexole. |
|
ROPINIRole |
CNS Depressants may enhance the sedative effect of ROPINIRole. |
|
Rotigotine |
CNS Depressants may enhance the sedative effect of Rotigotine. |
|
Rufinamide |
May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. |
|
Selective Serotonin Reuptake Inhibitors |
CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. |
|
Tetrahydrocannabinol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Tetrahydrocannabinol and Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Trimeprazine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Risk Factor D (Consider therapy modification) |
|
|
Blonanserin |
CNS Depressants may enhance the CNS depressant effect of Blonanserin. |
|
Buprenorphine |
|
|
Chlormethiazole |
May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. |
|
Cimetidine |
May increase the serum concentration of Zaleplon. Management: The initial dose of zaleplon should be limited to 5 mg in patients taking cimetidine. Monitor patients for increased zaleplon effects/toxicities (ie, sedation, CNS depression) when these agents are combined. |
|
CYP3A4 Inducers (Strong) |
May decrease the serum concentration of Zaleplon. Management: Consider the use of an alternative hypnotic that is not metabolized by CYP3A4 in patients receiving strong CYP3A4 inducers. If zalephon is combined with a strong CYP3A4 inducer, monitor for decreased effectiveness of zaleplon. |
|
Droperidol |
May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. |
|
Flunitrazepam |
CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. |
|
HYDROcodone |
CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Methotrimeprazine |
CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. |
|
Opioid Agonists |
CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
OxyCODONE |
CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Perampanel |
May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. |
|
Suvorexant |
CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. |
|
Tapentadol |
May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Zolpidem |
CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. |
|
Risk Factor X (Avoid combination) |
|
|
Azelastine (Nasal) |
CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). |
|
Bromperidol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Orphenadrine |
CNS Depressants may enhance the CNS depressant effect of Orphenadrine. |
|
Oxomemazine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Paraldehyde |
CNS Depressants may enhance the CNS depressant effect of Paraldehyde. |
|
Sodium Oxybate |
Hypnotics (Nonbenzodiazepine) may enhance the CNS depressant effect of Sodium Oxybate. |
|
Thalidomide |
CNS Depressants may enhance the CNS depressant effect of Thalidomide. |
Monitor:
- Alertness during the day time.
- Assess the risk of falls
- Respiratory rate in patients with compromised respiration
- behavior changes
- Tolerance
- Abuse, and
- Dependence
- Patients must be reevaluated if insomnia persists after one month of its use.
How to take Zaleplon?
- Do not take the drug before you go to bed, or if you are unable to fall asleep.
- High-fat meals slow down the absorption of nutrients and should be avoided with high-fat meals.
Mechanism of action of Zaleplon:
Zaleplon (sonata), a rapid-acting, hypnotic drug, interacts with the GABA receptor complex of benzodiazepines and is not related to benzodiazepines or barbiturates.
AbsorptionWhen taken with high-fat meals, it is fast and complete. The drug can be purchased for between 45% and 75%.
Protein-boundIt is widely used.
Metabolizedvia aldehydeoxidase to create 5-oxo-zaleplon for inactive metabolites
It has been abioavailabilityAbout 30% to 30%
Eliminating half-lifeOne hour.
Time to get therePeak plasma concentrationIt takes one hour.
ExcretionIt is mostly via urine (70%).
International Brands of Zaleplon:
- Andante
- Demare
- Easysleep
- Eplon
- Hegon
- Liplon
- Onsleep
- Plenidon
- Prox
- Selofen
- Siesta
- Siweitan
- Solmin
- Somna
- Sonata
- Sotalon
- Zalosed
- Zalpilo
- Zan
- Zaplon
- Zerene
Zaleplon Brands in Pakistan:
No Brands Available in Pakistan.
