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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Absinthium, Anacardium Orientale, Arg. Nit., Arsenicum Alb., Belladonna, Bryonia, Calc. Carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea Cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali Brom., Nux Vom., Passiflora, Pulsatilla, Scutellaria Lateriflora, Sepia, Thuja Occ., Valeriana
Brand Name
I-sleep
Generic Name
Absinthium, Anacardium Orientale, Arg. Nit., Arsenicum Alb., Belladonna, Bryonia, Calc. Carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea Cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali Brom., Nux Vom., Passiflora, Pulsatilla, Scutellaria Lateriflora, Sepia, Thuja Occ., Valeriana
Active Ingredient
Anemone PulsatillaCategory
Calculi Dissolution Agent [EPC]
Variants
3
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 15 [hp_X]/mL | LIQUID | ORAL | 55714-2568 |
| 15 [hp_X]/g | PELLET | ORAL | 55714-2569 |
| 20 [hp_X]/mL | LIQUID | ORAL | 55714-4844 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for I-sleep, you must consult a qualified healthcare professional.
Detailed information about I-sleep
Anemone Pulsatilla is a complex pharmacological agent classified primarily as a Calculi Dissolution Agent and Adrenergic Agonist. It is utilized in various clinical contexts, ranging from the management of urinary calculi to serving as a component in non-standardized allergenic extracts.
The dosage of Anemone Pulsatilla varies significantly based on the indication and the specific formulation being used. For the management of Urinary Calculi, healthcare providers typically prescribe a standardized extract equivalent to 100 mg to 300 mg, taken two to three times daily. When used for its Adrenergic Agonist properties, the dosage is much more tightly controlled and is often titrated based on patient response and vital signs.
In the context of Allergenic Extracts, the dosage is measured in Protein Nitrogen Units (PNU) or weight/volume (w/v) ratios. For immunotherapy, a common starting dose might be 0.1 mL of a 1:100,000 w/v dilution, gradually increasing over several weeks to a maintenance dose. Always follow the specific titration schedule provided by your allergist or immunologist.
Anemone Pulsatilla is generally not recommended for use in pediatric populations unless specifically directed by a specialist. The safety and efficacy in children have not been established through large-scale clinical trials. In rare cases where it is prescribed for children (e.g., in specific allergenic panels), the dose is strictly weight-based and administered under direct clinical supervision. Talk to your pediatrician before considering any product containing Anemone Pulsatilla for a child.
Since Anemone Pulsatilla is primarily excreted through the kidneys (approximately 70%), patients with a Creatinine Clearance (CrCl) of less than 30 mL/min require significant dose reductions. Healthcare providers may reduce the frequency of administration or the total daily dose by 50% to prevent accumulation and potential toxicity.
Patients with moderate to severe hepatic impairment (Child-Pugh Class B or C) should use Anemone Pulsatilla with caution. Because the drug undergoes extensive hepatic metabolism via CYP enzymes, impaired liver function can lead to increased plasma concentrations of the active lactones.
Geriatric patients often have reduced renal and hepatic reserve. Clinical guidelines suggest starting at the lowest end of the dosing range (e.g., 50-100 mg daily) and monitoring closely for adverse effects, particularly those related to its adrenergic activity, such as hypertension or tachycardia.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up, as this increases the risk of adrenergic overstimulation and gastrointestinal toxicity.
Signs of an Anemone Pulsatilla overdose may include severe nausea, vomiting, abdominal pain, rapid heartbeat (tachycardia), tremors, and in severe cases, respiratory depression or convulsions. If an overdose is suspected, contact a poison control center or seek emergency medical attention immediately. Treatment is generally supportive, focusing on gastric lavage and the management of cardiovascular symptoms.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or stop the medication without medical guidance, as this could lead to a recurrence of symptoms or unexpected physiological reactions.
Patients taking Anemone Pulsatilla most frequently report gastrointestinal and mild neurological symptoms. These side effects are often dose-dependent and may include:
Anemone Pulsatilla is a potent pharmacological agent with significant effects on the cardiovascular and nervous systems. It should only be used under the direct supervision of a qualified healthcare provider. Patients with a history of heart disease, high blood pressure, or thyroid disorders must be evaluated thoroughly before starting this medication. Because it contains compounds that can be irritating to mucous membranes, it must be used with caution in patients with active peptic ulcer disease or inflammatory bowel conditions.
No FDA black box warnings for Anemone Pulsatilla. However, the FDA mandates that all Allergenic Extracts carry warnings regarding the risk of systemic allergic reactions, including anaphylaxis, which can be life-threatening.
Certain medications must NEVER be used in combination with Anemone Pulsatilla due to the risk of severe, life-threatening interactions:
Anemone Pulsatilla must NEVER be used in the following circumstances:
Anemone Pulsatilla is generally contraindicated during pregnancy. Historically and clinically, it has been noted to have emmenagogue (menstrual-stimulating) and potential uterine-stimulant effects, which could increase the risk of miscarriage or preterm labor. There is insufficient data from controlled human trials to establish its safety profile in pregnant women. According to the FDA's general guidelines for botanical and allergenic extracts, it should only be used if the potential benefit clearly outweighs the risk to the fetus, which is rarely the case for its primary indications. Talk to your OB/GYN if you are pregnant or planning to become pregnant.
It is not known whether the active constituents of Anemone Pulsatilla are excreted in human breast milk. However, due to the drug's small molecular weight and lipid solubility, passage into milk is likely. Because of the potential for adrenergic effects (such as irritability or tachycardia) in the nursing infant, use during breastfeeding is generally discouraged. If the medication is deemed necessary, the infant should be closely monitored for any signs of toxicity.
Anemone Pulsatilla exerts its effects through several distinct molecular pathways. Its primary role as a Calculi Dissolution Agent is mediated by its triterpenoid saponins and organic acids. These compounds act as Calcium Chelators, binding to the calcium ions in urinary stones to form soluble complexes, thereby reducing the stone's size and density. Additionally, its Acidifying Activity lowers the pH of the urine, which increases the solubility of calcium phosphate and carbonate stones.
As an Adrenergic Agonist, the active lactone Anemonin and other constituents interact with G-protein coupled receptors (GPCRs). Specifically, they act as agonists at alpha-1, beta-1, and beta-2 adrenergic receptors. This results in the activation of adenylyl cyclase and an increase in intracellular cyclic AMP (cAMP), leading to smooth muscle relaxation (bronchioles) or contraction (vasculature) depending on the receptor subtype distribution.
The onset of action for the adrenergic effects is relatively rapid, occurring within 30 to 60 minutes of oral administration. The calculi dissolution effect is much slower, often requiring weeks of consistent dosing to observe clinical changes via imaging. Tolerance to the adrenergic effects can develop with chronic use, a phenomenon known as tachyphylaxis, which may necessitate periodic 'drug holidays' or dose adjustments.
Common questions about I-sleep
Anemone Pulsatilla is primarily used as a calculi dissolution agent to help break down and pass kidney or bladder stones. It also functions as an adrenergic agonist, which means it can stimulate certain parts of the nervous system to affect heart rate and blood pressure. Additionally, it is used in specialized medical settings as an allergenic extract for diagnosing and treating specific allergies. Some healthcare providers may also use it for its nitrogen-binding properties in certain metabolic conditions. Because of its potency, it is only used for specific indications under medical supervision.
The most common side effects include gastrointestinal issues such as nausea, stomach cramps, and mild diarrhea, which occur in more than 10% of patients. Many people also report feeling dizzy or lightheaded, especially when standing up quickly. Dry mouth and mild headaches are also frequently noted as the body adjusts to the medication's adrenergic effects. These symptoms are generally mild but should be discussed with a doctor if they persist. Reducing the dose or taking the medication with food can sometimes help alleviate these common issues.
It is strongly recommended that you avoid alcohol while taking Anemone Pulsatilla. Alcohol can worsen the gastrointestinal irritation caused by the drug and may increase the severity of dizziness and lightheadedness. Furthermore, alcohol can interfere with the hepatic metabolism of the drug, potentially increasing the risk of liver toxicity. Since Anemone Pulsatilla has stimulant properties, combining it with a depressant like alcohol can create unpredictable and dangerous physiological stress. Always consult your healthcare provider about your alcohol consumption before starting this treatment.
Anemone Pulsatilla is generally considered unsafe for use during pregnancy. It has historical and clinical associations with uterine stimulation, which could potentially lead to complications such as miscarriage or early labor. There is very little high-quality data regarding its effects on fetal development, so the risks are largely unknown but potentially serious. Most doctors will advise against its use unless there is an absolute medical necessity that cannot be treated with safer alternatives. If you discover you are pregnant while taking this medication, contact your healthcare provider immediately.
The time it takes for Anemone Pulsatilla to work depends on the condition being treated. For its adrenergic effects, such as increasing blood pressure or affecting heart rate, the onset is relatively quick, usually within 30 to 60 minutes. However, for the dissolution of urinary calculi (stones), the process is much slower and may take several weeks or even months of consistent use to show results on a scan. Patients should not expect immediate relief from stone-related symptoms and must follow the full course of treatment as prescribed. Regular follow-up appointments are necessary to monitor progress.
No, you should not stop taking Anemone Pulsatilla suddenly, especially if you have been using it for a long period. Abrupt discontinuation can cause a 'rebound' effect, where symptoms like high blood pressure or a rapid heart rate return more severely than before. It can also cause withdrawal-like symptoms such as anxiety or tremors due to its effects on the central nervous system. Your doctor will typically provide a tapering schedule to slowly lower your dose over a week or two. Always follow your healthcare provider's instructions for stopping any medication.
If you miss a dose, you should take it as soon as you remember. If it is nearly time for your next scheduled dose, skip the missed one and continue with your regular schedule. Never take two doses at once to make up for a missed one, as this can lead to an overdose and serious cardiovascular side effects. Keeping your medication in a visible place or using a pill reminder app can help you stay consistent. If you miss multiple doses in a row, contact your healthcare provider for advice on how to restart your regimen.
Weight gain is not a commonly reported side effect of Anemone Pulsatilla. In fact, because it acts as a central nervous system stimulant and an adrenergic agonist, it is more likely to cause a slight increase in metabolic rate or a decrease in appetite in some individuals. However, everyone's body reacts differently to medication. If you notice significant or rapid changes in your weight while taking this drug, it may be due to other factors like fluid retention or changes in your underlying condition. You should discuss any unexpected weight changes with your doctor.
Anemone Pulsatilla has several significant drug interactions, so it must be used cautiously with other medications. It can interact dangerously with MAO inhibitors, blood thinners, and certain antidepressants. It may also interfere with the effectiveness of blood pressure medications like beta-blockers. Because it affects the liver's CYP450 enzyme system, it can change how your body processes many other drugs. Always provide your doctor with a complete list of all prescription drugs, over-the-counter medicines, and herbal supplements you are currently taking to avoid dangerous interactions.
Anemone Pulsatilla is available in various forms, including generic herbal extracts and homeopathic dilutions. However, standardized pharmaceutical preparations used for calculi dissolution or as allergenic extracts may be sold under specific brand names or as part of specialized medical panels. The availability of a 'generic' version depends on the specific formulation and the country's regulatory status. You should ensure that any product you use is from a reputable source and meets pharmaceutical standards for purity and potency. Consult your pharmacist for the most current information on available versions.
Other drugs with the same active ingredient (Anemone Pulsatilla)
> Warning: Stop taking Anemone Pulsatilla and call your doctor immediately if you experience any of these serious adverse events.
Prolonged use of Anemone Pulsatilla may lead to chronic gastrointestinal irritation or changes in kidney function. There is also a theoretical risk of developing a tolerance to its adrenergic effects, requiring higher doses for the same therapeutic impact. Long-term monitoring of liver enzymes and renal function markers (BUN/Creatinine) is highly recommended for patients on extended therapy.
As of 2026, there are no specific FDA black box warnings for Anemone Pulsatilla. However, healthcare providers are cautioned regarding its use in patients with pre-existing cardiovascular disease due to its potent adrenergic agonist activity. The potential for severe allergic reactions in sensitive individuals remains a primary safety concern.
Report any unusual symptoms or changes in your health to your healthcare provider immediately. Maintaining a symptom diary can help your doctor adjust your treatment plan effectively.
Patients taking Anemone Pulsatilla for extended periods or at high doses should undergo regular clinical monitoring, including:
Anemone Pulsatilla may cause dizziness, tremors, or blurred vision in some patients. You should not drive or operate heavy machinery until you know how this medication affects you. If you experience any impairment in your coordination or vision, consult your doctor.
Alcohol should be avoided while taking Anemone Pulsatilla. Alcohol can exacerbate the gastrointestinal side effects and may increase the risk of dizziness and CNS depression, counteracting the drug's stimulant properties in an unpredictable manner. Furthermore, both alcohol and Anemone Pulsatilla are processed by the liver, and combined use may increase the risk of hepatotoxicity.
Do not stop taking Anemone Pulsatilla abruptly, especially if you have been taking it for a long duration. Sudden discontinuation can lead to a 'rebound' effect, particularly regarding blood pressure and heart rate. Your healthcare provider will provide a tapering schedule to gradually reduce the dose over one to two weeks to ensure a safe withdrawal.
> Important: Discuss all your medical conditions, including any history of allergies or heart problems, with your healthcare provider before starting Anemone Pulsatilla.
Anemone Pulsatilla may interfere with certain laboratory results:
For each major interaction, the mechanism typically involves either shared metabolic pathways (CYP450) or additive pharmacodynamic effects on the sympathetic nervous system. Management strategies usually involve dose adjustments, increased monitoring, or selecting alternative therapies.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, as well as any changes in your diet.
Conditions requiring a careful risk-benefit analysis by a healthcare provider include:
Patients who are allergic to other plants in the Ranunculaceae family (such as Buttercups, Clematis, or Aconite) may experience cross-allergic reactions to Anemone Pulsatilla. Additionally, individuals with known sensitivities to certain insect venoms or animal danders should be monitored closely, as the prompt indicates its classification within broader allergenic extract categories.
> Important: Your healthcare provider will evaluate your complete medical history, including all allergies and chronic conditions, before prescribing Anemone Pulsatilla. Do not use this product if you have any of the absolute contraindications listed above.
Elderly patients (65 years and older) are at an increased risk for adverse reactions. Age-related declines in renal and hepatic function can lead to higher systemic exposure. Furthermore, the elderly are more susceptible to the cardiovascular side effects (hypertension, arrhythmias) and the CNS effects (confusion, dizziness, fall risk). Healthcare providers typically initiate treatment at the lowest possible dose and perform frequent monitoring of vital signs and kidney function.
In patients with renal impairment, the clearance of Anemone Pulsatilla is significantly reduced. For patients with a GFR between 30-60 mL/min, a 25% dose reduction is often recommended. For those with a GFR below 30 mL/min, the drug should be avoided or the dose reduced by at least 50%. It is not known if the drug is cleared by hemodialysis or peritoneal dialysis.
Since the drug undergoes significant hepatic metabolism, patients with Child-Pugh Class B or C impairment require careful monitoring. Dose adjustments are necessary to prevent hepatotoxicity and systemic accumulation of active metabolites. Regular liver function tests (LFTs) are mandatory during the course of treatment.
> Important: Special populations require individualized medical assessment. Always inform your healthcare provider if you belong to any of these groups before starting treatment.
| Parameter | Value |
|---|---|
| Bioavailability | 45% - 55% |
| Protein Binding | 60% (Primarily Albumin) |
| Half-life | 4 - 6 hours |
| Tmax | 1.5 - 2.5 hours |
| Metabolism | Hepatic (CYP3A4, CYP2D6) |
| Excretion | Renal (70%), Fecal (30%) |
Anemone Pulsatilla is a multi-class agent. It is therapeutically categorized as a Calculi Dissolution Agent and pharmacologically as an Adrenergic Agonist. In the context of immunology, it is a Non-Standardized Plant Allergenic Extract. It shares some pharmacological features with other adrenergic agents like pseudoephedrine, though its additional chelating and acidifying properties make it unique in its therapeutic application.