Essential Oils of: Lavender , Marjoram , sweet Orange , Jasmine , Chamomile , Basil .
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Below is general information about the effectiveness of the known ingredients contained in the product Slumber Time Essential Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Slumber Time Essential Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Basil has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used topically in medicinal amounts. Solutions containing up to 6% basil essential oil have been used with apparent safety for up to 12 weeks (103622). There is insufficient reliable information available about the safety of basil when inhaled as aromatherapy.
POSSIBLY UNSAFE ...when used orally in medicinal amounts. Both the above ground parts and the oil of basil contain estragole, which might be hepatocarcinogenic and mutagenic (2,8,12).
CHILDREN: LIKELY SAFE
when the above ground parts are used in amounts commonly found in foods.
CHILDREN: POSSIBLY UNSAFE
when used orally in medicinal amounts due to the estragole constituent (2,8).
PREGNANCY AND LACTATION: LIKELY SAFE
when the above ground parts are used in amounts commonly found in foods.
PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used in larger amounts due to the estragole constituent of the essential oil.
Estragole might have mutagenic effects (2,12).
LIKELY SAFE ...when used orally in the amounts commonly found in foods. Jasmine has Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of jasmine in medicinal amounts.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts greater than those found in food.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Lavender has Generally Recognized as Safe (GRAS) status for food use in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (9792). In clinical research, a specific product containing lavender oil (Silexan, Dr Willmar Schwabe GmbH & Co. KG) has been used safely at doses of 80-160 mg daily for up to 10 weeks (58077,58080,58098,97257,112255). Powdered dried lavender flowers 500 mg twice daily has also been used with apparent safety for up to 8 weeks (97256). ...when used topically and appropriately. Lavender oil has been used safely for up to 7 months in adults (5177,109858,109865). ...when the essential oil is inhaled as a part of aromatherapy. Clinical studies have used lavender oil aromatherapy with apparent safety for up to 12 weeks (7107,12213,16393,16394,95634,103062,103063,103065,103068).
CHILDREN: POSSIBLY SAFE
when the essential oil is inhaled as a part of aromatherapy.
Clinical studies have used lavender oil aromatherapy with apparent safety in single doses for up to 2 hours (109868,112260).
CHILDREN: POSSIBLY UNSAFE
when applied topically in males.
Anecdotal reports suggest that applying topical products containing lavender oil to prepubertal males may result in gynecomastia in some cases (15254,95643). Products with a higher concentration of lavender oil and more frequent applications might be more likely to result in gynecomastia.
PREGNANCY AND LACTATION:
Insufficient reliable evidence available.
Preliminary clinical research shows that lavender essential oil can be inhaled during labor, with no apparent adverse outcomes in the infants (95633). Although this study suggests safety, high quality assessment of safety has not been conducted.
LIKELY SAFE ...when used in amounts commonly found in foods. Marjoram and its essential oil have Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when the leaf is used orally and appropriately in tea, short-term (12,18). ...when marjoram oil is used orally and appropriately, short-term (11).
POSSIBLY UNSAFE ...when the flower, leaf, and oil are used orally, long-term. Marjoram contains arbutin, a hydroquinone glycoside (2,18). Studies in animals suggest that long-term use of hydroquinone can damage the liver and kidneys and might cause cancer (2,76395,95524). There is insufficient reliable information available about the safety of marjoram when used topically.
PREGNANCY: POSSIBLY UNSAFE
when used in medicinal amounts; marjoram has the potential for stimulating menstruation (19,95324).
Avoid amounts greater than those found in foods.
LACTATION:
Insufficient reliable information available; avoid amounts greater than those found in foods.
LIKELY SAFE ...when sweet orange juice or fruit is used orally in amounts commonly found in foods (1310,3340,15171,92309,114401).
POSSIBLY SAFE ...when the essential oil of sweet orange is inhaled as aromatherapy, short-term (35735,58060,90505,105455). There is insufficient reliable information available about the safety of sweet orange peel when used orally.
CHILDREN: LIKELY SAFE
when sweet orange juice or fruit is used orally in amounts commonly found in foods.
CHILDREN: POSSIBLY UNSAFE
when the sweet orange peel is used orally in excessive amounts.
There have been reports of intestinal colic, convulsions, and death in children given large amounts of sweet orange peel (11).
PREGNANCY AND LACTATION: LIKELY SAFE
when sweet orange juice or fruit is used orally in amounts commonly found in foods (1310,3340).
Below is general information about the interactions of the known ingredients contained in the product Slumber Time Essential Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, basil might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.
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Theoretically, basil might increase the risk of hypotension when taken with antihypertensive drugs.
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Animal research suggests that basil extract can reduce systolic and diastolic blood pressure (76893).
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Theoretically, lavender might potentiate the therapeutic effects and adverse effects of CNS depressants.
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Laboratory research suggests that lavender has sedative effects (7). However, clinical studies in patients taking oral lavender oil (Silexan) 160 mg for 10 weeks or taking lavender flower powder 1 gram daily for 2 months have not reported side effects of drowsiness, sedation, or sleepiness (97256,103061). There is still some concern that higher doses or different preparations of lavender might have additive effects with CNS depressant medications.
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In vitro research suggests that marjoram extract can inhibit acetylcholinesterase activity (31438,76912). Theoretically, using marjoram in medicinal amounts along with anticholinergic drugs might decrease the effectiveness of marjoram or the anticholinergic agent.
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Some anticholinergic drugs include atropine, benztropine (Cogentin), biperiden (Akineton), procyclidine (Kemadrin), and trihexyphenidyl (Artane).
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In vitro research suggests that marjoram extract inhibits platelet aggregation and adhesion (76932). Theoretically, marjoram might increase the risk of bleeding when used in medicinal amounts along with antiplatelet or anticoagulant drugs.
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Some anticoagulant or antiplatelet drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.
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In vitro research suggests that marjoram extract can inhibit acetylcholinesterase activity (31438,76912). Theoretically, using marjoram in medicinal amounts along with cholinergic drugs might have additive effects and increase the risk of cholinergic side effects.
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Cholinergic drugs include bethanechol (Urecholine), donepezil (Aricept), echothiophate (Phospholine Iodide), edrophonium (Enlon, Reversol, Tensilon), neostigmine (Prostigmin), physostigmine (Antilirium), pyridostigmine (Mestinon, Regonol), succinylcholine (Anectine, Quelicin), and tacrine (Cognex).
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Consuming sweet orange with celiprolol can decrease oral absorption of celiprolol.
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A pharmacokinetic study in healthy volunteers shows that celiprolol levels, after a single dose of 100 mg, are decreased by up to 90% in people who drink sweet orange juice 200 mL three times daily. It's not known if lower consumption of sweet orange juice will have the same effect. Theoretically, this occurs due to short-term inhibition of organic anion transporting polypeptide (OATP) (12115,17603,17604). Recommend separating drug administration and consumption of sweet orange by at least 4 hours (17603,17604).
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Consuming sweet orange juice with fexofenadine can decrease oral absorption of fexofenadine.
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Clinical research shows that coadministration of sweet orange juice 1200 mL decreases bioavailability of fexofenadine by about 72% (7046,17604). In an animal model, sweet orange juice decreased bioavailability of fexofenadine by 31% (17605). Fexofenadine manufacturer data indicates that concomitant administration of sweet orange juice and fexofenadine results in larger wheal and flare sizes in research models. This suggests that sweet orange reduces the clinical response to fexofenadine (17603). Theoretically, this occurs due to short-term inhibition of organic anion transporting polypeptide (OATP) (7046). Recommend separating drug administration and consumption of sweet orange by at least 4 hours (17603,17604).
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Consuming sweet orange juice with ivermectin can decrease the oral absorption of ivermectin.
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A pharmacokinetic study in healthy volunteers shows that taking ivermectin orally with sweet orange juice 750 mL over 4 hours reduces the bioavailability of ivermectin. This effect does not seem to be related to effects on P-glycoprotein. The effect on ivermectin is more pronounced in males compared to females (12154).
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Consuming sweet orange juice can decrease oral absorption of OATP substrates. Separate administration by at least 4 hours.
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Clinical research shows that consuming sweet orange juice inhibits OATP, which reduces bioavailability of oral drugs that are substrates of OATP (17603,17604). For example, sweet orange juice decreases bioavailability of fexofenadine, a substrate of OATP, by about 72% and of celiprolol, another OATP substrate, by up to 90% (7046,12115). Since sweet orange juice seems to affect OATP for a short time, recommend separating drug administration and consumption of sweet orange juice by at least 4 hours (17603,17604).
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Sweet orange juice seems to modulate P-glycoprotein (P-gp), which might affect the blood levels of P-gp substrates.
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Animal and in vitro research suggest that orange juice extract inhibits drug efflux by P-gp, increasing absorption and levels of P-gp substrates (12116,15327). In contrast, pharmacokinetic research in humans shows that drinking large amounts of sweet orange juice decreases absorption and levels of the P-gp substrate celiprolol. This suggests that orange juice actually induces drug efflux by P-gp or affects drug levels by another mechanism such as inhibiting the gut drug transporter called organic anion transporting polypeptide (OATP) (7046,12115). Until more is known, sweet orange juice should be used cautiously in people taking P-gp substrates.
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Consuming sweet orange juice with pravastatin can increase the absorption of pravastatin.
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A small pharmacokinetic study in healthy volunteers shows that consuming sweet orange juice 800 mL over 3 hours, including before, during, and after taking pravastatin 10 mg, increases pravastatin levels by about 149%, without affecting pravastatin elimination. Theoretically this effect might be due to modulation of organic anion transporting polypeptides (OATPs) by sweet orange juice (14348). Sweet orange juice does not seem to affect simvastatin levels, but it is not known if sweet orange affects any of the other statins.
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Calcium-fortified sweet orange juice might reduce quinolone absorption.
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Below is general information about the adverse effects of the known ingredients contained in the product Slumber Time Essential Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General ...Topically, basil seems to be well tolerated.
Immunologic ...Allergic contact dermatitis has been reported in a 45-year old woman with occupational exposure to basil (95140).
General ...Topically, jasmine may cause allergic contact dermatitis, delayed-type hypersensitivity, and type 1 hypersensitivity (56955,57027,57032,98684).
Immunologic ...Topically, jasmine essential oil and jasmine flower can cause allergic contact dermatitis (56955,57027,57032). Among patients who are sensitive to fragrance materials, jasmine may cause delayed-type hypersensitivity. The reported prevalence of this type of reaction ranges from 0.4% to 1.6% (89684). One case of type 1 hypersensitivity to jasmine has also been reported. The patient experienced chest tightness, wheezing, itchy skin, and macular erythematous eruption within minutes of exposure to jasmine. The eruption subsided within 20 minutes of moving away from the plant. An immunoblotting assay revealed IgE reactivity (98684).
General
...Orally, lavender is well tolerated in food amounts and seems to be well tolerated in larger amounts.
Topically, lavender oil seems to be well tolerated.
Most Common Adverse Effects:
Orally: Breath odor, constipation, diarrhea, dyspepsia, eructation, headache, and nausea.
Topically: Allergic contact dermatitis (with lavender oil).
Serious Adverse Effects (Rare):
Topically: Cases of gynecomastia have been reported in prepubertal males using lavender oil.
Cardiovascular ...Orally, a specific lavender oil ingredient (Silexan) has been associated with palpitations (103061).
Endocrine ...Topical products containing lavender oil alone, including a product referred to as agua de violetas, or in combination with tea tree oil have been linked to at least six cases of gynecomastia when used in prepubertal males. In each case, gynecomastia resolved when the lavender oil products were discontinued. It is thought that the estrogenic and antiandrogenic activity of lavender oil and tea tree oil resulted in gynecomastia in these cases (15254,95643).
Gastrointestinal ...Orally, lavender oil, including a specific lavender oil ingredient KG), may cause gastrointestinal disturbance, including dyspepsia, diarrhea, breath odor, eructation, and nausea (58077,58080,58098,93004,103061). Tincture of lavender has been linked to cases of constipation and increased appetite; however, it is unknown if this occurred at a greater rate than with placebo (9792).
Immunologic ...Topically, use of lavender oil, such as in personal care products, might cause allergic contact dermatitis in some patients (6,101728). There have been numerous case reports of allergic contact dermatitis and eczema linked to lavender oil exposure from shampoos, lotions, fragrances, or direct application of oil to pillows (10031,58043,58109,58120,101728,112253). In one case series, only 4 out of 15 cases of allergic contact dermatitis due to lavender had positive patch tests for lavender. Oxidation products of lavender essential oils such as linalool, linalyl acetate, limonene, cineol, geraniol, eugenol, and isoeugenol may be more allergenic than un-oxidized lavender essential oil, which may result in a false negative patch test (112253).
Neurologic/CNS ...Orally, lavender flower powder, tincture of lavender containing 50% alcohol, and a specific lavender oil ingredient (Silexan) have been linked to headache (9792,103061,109860). Headache has also been reported rarely following lavender oil aromatherapy (109860).
Pulmonary/Respiratory ...In one case report, a 34-year-old Japanese female presented with complaints of dyspnea, cough, and fever 2 weeks after initiating lavender essential oil therapy via humidifier. The patient had an oxygen saturation of 88% and was diagnosed with acute eosinophilic pneumonia. Symptoms improved after a course of corticosteroids and discontinuation of aromatherapy (109979).
Renal ...In one case report, a 24-year-old male presented with shortness of breath, weakness, nausea, and decreased urine output following the intake of Spanish lavender tea twice daily for 5 days. After presenting to the hospital, the patient was diagnosed with acute kidney failure secondary to acute interstitial nephritis likely due to lavender consumption (112259).
General
...Orally, marjoram and its essential oil are well tolerated in amounts commonly found in foods (4912).
Marjoram leaf and marjoram oil seem to be well tolerated when used appropriately for medicinal purposes (2,11,12,18). However, marjoram flower, leaf, and oil should not be used long-term due to the arbutin content (2,76395,95524).
Topically, there are rare reports of allergic skin reactions with marjoram use (33865,58049).
Immunologic ...Possible allergic contact dermatitis in children with pre-existing childhood atopic eczema was observed in a randomized clinical trial employing extended use of essential oils, including sweet marjoram essential oil (58049). A case report describes a 38-year old woman who had an exacerbation of perioral dermatitis after eating food seasoned with marjoram. The dermatitis resolved within 3 weeks on a marjoram-free diet, but reappeared when she was rechallenged with marjoram (33865).
General ...Orally, sweet orange juice or fruit seem to be well tolerated. Large amounts of sweet orange peel may be unsafe, especially for children. When inhaled, sweet orange essential oil seems to be generally well tolerated.
Gastrointestinal ...There have been reports of intestinal colic in children following ingestion of large amounts of sweet orange peel (11).
Neurologic/CNS ...There have been reports of convulsions in children following ingestion of large amounts of sweet orange peel (11).