Ingredients | Amount Per Serving |
---|---|
Calories
|
10 Calorie(s) |
Organic Herbal Sleep Blend
|
405 mg |
(leaf)
|
300 mg |
(flower)
|
50 mg |
organic Chamomile (flower) extract
(flower)
|
50 mg |
(flower)
|
5 mg |
(from organic Green Tea extract)
(L-Theanine (Form: from organic Green Tea extract) )
|
100 mg |
Water, Purified, organic Vegetable Glycerin (Form: from non-GMO Corn), Mandarin peel flavor PlantPart: peel, non-GMO Citric Acid, organic Citrus extract Note: to preserve freshness
Below is general information about the effectiveness of the known ingredients contained in the product Sleep Well R&R Spray. 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
Below is general information about the safety of the known ingredients contained in the product Sleep Well R&R Spray. 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. Hibiscus sabdariffa has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Hibiscus sabdariffa tea has been safely consumed in amounts of up to 720 mL daily for up to 6 weeks (16894,93805,93814). Hibiscus sabdariffa extracts, including a specific Hibiscus sabdariffa leaf extract (Green Chem), have also been safely used in doses of up to 1000 mg daily for up to 90 days (17415,54989,93805,93809,105307).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Hibiscus sabdariffa calyx powder has been used with apparent safety at a dose of 2 grams three times daily for 4 weeks by adolescents aged 12-18 years (93816).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Hibiscus sabdariffa is thought to be a menstrual stimulant, and might have abortifacient effects (19).
LACTATION: POSSIBLY UNSAFE
when used orally in large amounts.
Animal research found that administering large doses of Hibiscus sabdariffa during lactation decreases food and water intake during pregnancy and delays puberty in offspring (93810); however, this has not been assessed in humans.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Lemon balm has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately, short-term. Lemon balm extract has been used with apparent safety at a dose of 500 mg daily for 6 months or at a dose of 3000 mg daily for 2 months (9993,9994,104435,104435,110136). ...when used topically and appropriately, short-term. Lemon balm 1% dried leaf extract has been used up to 4 times daily with apparent safety for a few days (790,9995).
CHILDREN: POSSIBLY SAFE
when used orally and appropriate, short-term.
A single dose of lemon balm extract 3-6 mg/kg has been safely used in children aged 6-7 years (19525). A specific combination product providing lemon balm leaf extract 80 mg and valerian root extract 160 mg (Euvegal forte, Dr. Willmar Schwabe Pharmaceuticals) 1-2 tablets once or twice daily has been safely used in children under 12 years of age for 30 days (14416). In infants up to 4 weeks old, multi-ingredient products (ColiMil, ColiMil Plus) containing lemon balm 64-97 mg daily have been used with apparent safety for up to 7 days (16735,96278).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally as a flavoring in foods. The US Food and Drug Administration (FDA) lists passion flower as a permitted food flavoring additive, to be used in the minimum quantity necessary (91203).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Passion flower extract has been used with apparent safety at doses up to 800 mg daily for up to 8 weeks (88198,102866). A specific passion flower extract (Pasipay, Iran Darouk Pharmaceutical Company) has been safely used at a dose of 45 drops daily for up to one month (8007,95036). Also, a tea prepared by steeping 2 grams of the dried aerial parts of passion flower in 250 mL of boiling water for 10 minutes has been used nightly for 7 nights (17374). There is insufficient reliable information available about the safety of passion flower when used topically.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
A specific passion flower product (Pasipay, Iran Darouk Pharmaceutical Company) has been used safely in children aged 6-13 years at a dose of 0.04 mg/ kg daily for 8 weeks (88197).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Some case reports suggest that passion flower use during the first and second trimesters of pregnancy may be associated with an increased risk for premature rupture of membranes and meconium aspiration syndrome; however, causality has not been confirmed (97279). The alkaloids harman and harmaline, which are sometimes found in passion flower, have been reported to have uterine stimulant activity (4,11020,95037). It is not known whether these constituents are present in sufficient quantities to have an effect.
LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately, short-term. L-theanine has been used safely in clinical research in doses of up to 900 mg daily for 8 weeks (12188,36439,96331,96332,96334,96341,97923,101986,104976). There is insufficient reliable information available about the safety of L-theanine when used long-term.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
A specific L-theanine product (Suntheanine, Taiyo Kagaku) 200 mg twice daily has been used safely in males aged 8-12 years for up to 6 weeks (91744).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Sleep Well R&R Spray. 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, taking Hibiscus sabdariffa with acetaminophen might decrease the clinical effects of acetaminophen.
Details
There is some evidence that consuming a Hibiscus sabdariffa beverage (Zobo drink) before taking acetaminophen can decrease the elimination half-life of acetaminophen. Hibiscus sabdariffa does not seem to decrease maximum concentration or area under the curve of acetaminophen (12184). The clinical significance of this is unknown.
|
Theoretically, taking Hibiscus sabdariffa with antidiabetes drugs might increase the risk of hypoglycemia.
Details
|
Theoretically, taking Hibiscus sabdariffa with antihypertensive drugs might increase the risk of hypotension.
Details
|
Taking Hibiscus sabdariffa tea along with chloroquine seems to reduce levels of chloroquine.
Details
When taken together, Hibiscus sabdariffa tea significantly reduces the bioavailability of chloroquine (55004). This may reduce its clinical effects. People taking chloroquine for the treatment or prevention of malaria should avoid Hibiscus sabdariffa tea.
|
Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP1A2 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP1A2 (93811). This interaction has not been reported in humans.
|
Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2A6 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2A6 (93811). This interaction has not been reported in humans.
|
Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2B6 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2B6 (93811). This interaction has not been reported in humans.
|
Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2C19 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C19 (93811). This interaction has not been reported in humans.
|
Theoretically, Hibiscus sabdariffa might reduce the metabolism of CYP2C8 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C8 (93811). This interaction has not been reported in humans.
|
Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2C9 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C9 (93811). This interaction has not been reported in humans.
|
Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2D6 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2D6 (93811). This interaction has not been reported in humans.
|
Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2E1 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2E1 (93811). This interaction has not been reported in humans.
|
Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP3A4 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP3A4 (93811). This interaction has not been reported in humans.
|
Taking Hibiscus sabdariffa with diclofenac may increase the levels and adverse effects of diclofenac.
Details
Pharmacokinetic research in humans shows that drinking a beverage made with Hibiscus sabdariffa flowers reduces the excretion of diclofenac by approximately 38% when compared with water. The clinical significance of this is unknown (101726).
|
Theoretically, Hibiscus sabdariffa might increase the levels and clinical effects of losartan.
Details
Animal research in rats with laboratory-induced hypertension shows that providing Hibiscus sabdariffa for 14-17 days prior to a single administration with losartan modestly increases losartan concentrations and increases hypotensive effects when compared with a single administration of losartan alone (102459). It is not clear if Hibiscus sabdariffa alters the concentration or effects of losartan when taken continuously. Additionally, this interaction has not been shown in humans.
|
Taking Hibiscus sabdariffa with simvastatin might reduce the levels and clinical effects of simvastatin.
Details
A pharmacokinetic study in humans shows that taking a beverage prepared with dried Hibiscus sabdariffa flower 300 grams concurrently with a single dose of simvastatin 40 mg increases the clearance of simvastatin by about 45% and reduces peak levels of simvastatin by 18% (96270).
|
Theoretically, concomitant use of lemon balm might have additive effects with CNS depressant drugs.
Details
|
Theoretically, lemon balm might interfere with thyroid hormone replacement therapy.
Details
In vitro, constituents of lemon balm extract bind to thyroid stimulating hormone (TSH), preventing TSH receptor-binding and leading to the inhibition of TSH-stimulated adenylate cyclase activity (19727,19728). In animals, lemon balm extract has been shown to decrease levels of circulating TSH and inhibit thyroid secretion (19726).
|
Concomitant use of passion flower with sedative drugs might cause additive effects and side effects.
Details
|
Theoretically, passion flower might decrease the effects of CYP3A4 substrates.
Details
In vitro research suggests that passion flower can induce CYP3A4 enzymes, albeit to a much lower degree than rifampin, a known CYP3A4 inducer (110704).
|
Theoretically, passion flower might reduce the bioavailability of OATP2B1 and OATP1A2 substrates.
Details
In vitro research shows that the passion flower constituents apigenin and vitexin inhibit OATP2B1 and OATP1A2. This inhibition may be dose-dependent. One specific high-flavonoid passion flower extract (Valverde) seems to inhibit OATP2B1 and OATP1A2, while another extract with a lower flavonoid concentration (Arkocaps) shows less potent inhibition (105095). OATPs are responsible for the uptake of drugs and other compounds into the body; however, the specific activities of OATP2B1 and OATP1A2 are not well characterized.
|
Theanine might lower blood pressure, potentiating the effects of antihypertensive drugs.
Details
|
Theoretically, theanine might have additive sedative effects when used in conjunction with CNS depressants. However, it is unclear if this concern is clinically relevant.
Details
|
Below is general information about the adverse effects of the known ingredients contained in the product Sleep Well R&R Spray. 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 ...Orally, Hibiscus sabdariffa is generally well tolerated.
Gastrointestinal ...Orally, taking a specific Hibiscus sabdariffa leaf extract (Green Chem) 1 gram daily has been associated with reports of transient gastrointestinal symptoms such as abdominal distention, flatulence, and epigastric pain in one clinical trial. However, the overall rate of these adverse effects was similar to placebo (17415). Taking Hibiscus sabdariffa calyx extract 6 grams daily has been associated with single cases of nausea in one clinical trial (55000). Taking Hibiscus sabdariffa calyx powder 6 grams daily has been associated with reports of mild and transient constipation in one clinical trial (93816). Taking 0.5-1 liters of tea daily, made by steeping 10-15 grams of dried Hibiscus sabdariffa calyces, has been associated with one report of stomach pain in one clinical trial (101733).
Genitourinary ...Orally, taking Hibiscus sabdariffa calyx extract 6 grams daily has been associated with one report of dysuria in one clinical trial (55000).
Neurologic/CNS ...Orally, taking Hibiscus sabdariffa calyx extract 3 grams daily has been associated with one report of tremor and headache in one clinical trial (55000).
Ocular/Otic ...Orally, taking Hibiscus sabdariffa calyx extract 3 grams daily has been associated with one report of tinnitus in one clinical trial (55000).
Pulmonary/Respiratory ...Taking 0. 5-1 liters of tea daily, made by steeping 10, 15, or 20 grams of dried Hibiscus sabdariffa calyces, has been associated with two reports of dyspnea in one clinical trial. A clear association with Hibiscus sabdariffa could not be made (101733).
General
...Orally, lemon balm seems to be well tolerated in food amounts and larger, medicinal amounts.
Topically, lemon balm seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Wheezing has been rarely reported.
Cardiovascular ...Orally, a case of transient complete atrioventricular block and QT prolongation is reported in a 25-year-old female following the post-workout use of a specific product (Muscle Eze Advanced) containing lemon balm and several other ingredients. Symptoms of fatigue and lightheadedness started 1 week into use of the product. Product discontinuation led to restoration of normal sinus rhythm within 24 hours and normalization of the electrocardiogram within 2 weeks (112556). It is unclear whether this occurrence is due to lemon balm, other ingredients, or the combination.
Dermatologic ...Topically, lemon balm 1% cream applied 5 times daily to cold sores has been associated with two cases of irritation and one case of cold sore exacerbation. However, these effects do not appear to occur more often with lemon balm than with placebo (790).
Gastrointestinal ...Orally, lemon balm might increase appetite in some patients (91732,104433). Nausea, vomiting, and abdominal pain have been reported rarely and do not seem to occur more often than in patients taking placebo (9993).
Neurologic/CNS ...Orally, lemon balm has been reported to cause dizziness and sedation; however, it does not seem to occur more often with lemon balm than placebo (9993,104433). Additionally, other clinical research shows that using lemon balm in conjunction with alcohol does not affect reaction time or influence cognitive performance (19427,19723).
Pulmonary/Respiratory ...Orally, lemon balm has been associated with rare cases of wheezing (9993).
General
...Orally, passion flower is well tolerated.
Most Common Adverse Effects:
Orally: Confusion, dizziness, hypersensitivity, and sedation.
Cardiovascular ...There is a case report involving a 34-year-old female who was hospitalized with severe nausea, vomiting, drowsiness, prolonged QT interval, and episodes of nonsustained ventricular tachycardia following use of passion flower extract tablets (Sedacalm, Bioplus Healthcare), 1500 mg on day 1 and 2000 mg on day 2 to relieve stress. All symptoms resolved within one week after passion flower was discontinued (6251).
Genitourinary ...The alkaloids harman and harmaline, which are sometimes found in small amounts in passion flower, have been reported to have uterine stimulant activity (4,11020,95037).
Hematologic ...Orally, passion flower has been reported to cause epistaxis in one clinical trial (95038). Vasculitis has also been reported with use of a specific herbal product (Relaxir) produced mainly from the fruits of passion flower (6).
Hepatic ...There is debate about whether passion flower contains cyanogenic glycosides. Several related Passiflora species do contain these constituents (3), including Passiflora edulis, which is associated with liver and pancreatic toxicity (7).
Immunologic
...An idiosyncratic hypersensitivity reaction characterized by urticaria and cutaneous vasculitis has been reported in a 77-year-old male with rheumatoid arthritis after taking a specific combination product that included passion flower extract (Naturest) (68308).
It is unclear if these effects were caused by passion flower or other ingredients.
In clinical trials, passion flower has been reported to cause allergy symptoms including sinus irritation; however, the frequency of these events was statistically nonsignificant when compared to treatment with midazolam 15 mg (95038).
Musculoskeletal ...Orally, passion flower has been reported to cause muscle relaxation in a clinical trial (95038).
Neurologic/CNS ...Orally, sedation, dizziness, ataxia, and confusion have been reported in clinical trials. However, these events generally do not necessitate discontinuation (8007,15391,15392,95036,95038). Altered consciousness has been reported with use of a specific herbal product (Relaxir) produced mainly from the fruits of passion flower (6).
General
...Orally, L-theanine seems to be well tolerated.
Most Common Adverse Effects:
Orally: Drowsiness, headaches.
Neurologic/CNS
...Orally, L-theanine may cause headaches (36439).
Patients have also reported drowsiness, increased duration of sleep, and increased dream activity after oral L-theanine use (96331).
A case of subtle facial tic starting within 4 days of taking L-theanine 400 mg daily has been reported for a pediatric patient. Although the tics reportedly ceased once theanine was discontinued, the child had exhibited tics in the past. Therefore, the adverse effect was not thought to be related to L-theanine (91744).