Ingredients | Amount Per Serving |
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Proprietary Blend
|
400 mg |
(root)
(Valerenic Acid)
(0.8% Valerenic Acids)
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|
(Withania somnifera )
(root and leaf)
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|
(flower)
(4:1 Extract)
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|
(leaf)
(4:1 Extract)
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|
(Lavandula angustifolia )
(flower)
(10:1 Extract)
|
|
(Gamma-Aminobutyric Acid)
(4-Aminobutyric Acid)
|
100 mg |
100 mg | |
Melatonin XR
(Hydroxypropyl Methylcellulose, Melatonin, Palm Oil, Sunflower Lecithin)
|
5 mg |
Hydroxypropyl Methylcellulose Note: HPMC capsule, Magnesium Stearate (Alt. Name: Mg Stearate), Colloidal Silicon Dioxide
Below is general information about the effectiveness of the known ingredients contained in the product Sleep Support. 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
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 Support. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Ashwagandha has been used with apparent safety in doses of up to 1250 mg daily for up to 6 months (3710,11301,19271,90649,90652,90653,97292,101816,102682,102683) (102684,102685,102687,103476,105824,109586,109588,109589,109590). ...when used topically. Ashwagandha lotion has been used with apparent safety in concentrations up to 8% for up to 2 months (111538).
PREGNANCY: LIKELY UNSAFE
when used orally.
Ashwagandha has abortifacient effects (12).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods.
POSSIBLY SAFE ...when used orally in medicinal amounts, short-term. GABA has been used with apparent safety in doses of 75 mg to 1.5 grams daily for up to one month in small clinical studies (19361,19363,19369,110134,110135). There is insufficient reliable information available about the safety of GABA when used orally for longer than one month or when used sublingually or intravenously.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. German chamomile has Generally Recognized as Safe (GRAS) status in the US (4912,110318).
POSSIBLY SAFE ...when used orally, for medicinal purposes, short-term. German chamomile has been used with apparent safety at doses of up to 1500 mg daily for up to 26 weeks (6655,12724,12729,13089,19377,19716,104806,111380). ...when applied topically. A lotion containing 0.2% microencapsulated German chamomile extract has been applied to the skin with apparent safety for up to 35 days (108993). ...when used topically as an oral rinse (99853).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Preliminary clinical research suggests that several multi-ingredient products containing German chamomile are safe in infants when used for up to 4 weeks (16735,19705,19715,96278). ...when used topically and appropriately, short-term. Six drops of oil infused with German chamomile flower has been applied nightly with apparent safety for up to 6 weeks in children 6-18 years old (98621).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
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). 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 minutes (109868).
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 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.
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.
LIKELY SAFE ...when used orally and appropriately, short-term. Valerian 300-600 mg daily has been safely used in clinical studies in over 12,000 patients for up to 6 weeks (2074,3484,3485,4032,15018,17577,17578,19409,96242,103221)(104010,105718). There is insufficient reliable information available about the safety of valerian when used orally for longer than 6 weeks.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Valerian 160-320 mg has been used with apparent safety in children under 12 years of age for 4-8 weeks (14416).
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 Support. 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 ashwagandha with antidiabetes drugs might increase the risk of hypoglycemia.
Details
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Theoretically, taking ashwagandha with antihypertensive drugs might increase the risk of hypotension.
Details
Animal research suggests that ashwagandha might lower systolic and diastolic blood pressure (19279). Theoretically, ashwagandha might have additive effects when used with antihypertensive drugs and increase the risk of hypotension.
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Theoretically, taking ashwagandha might increase the sedative effects of benzodiazepines.
Details
There is preliminary evidence that ashwagandha might have an additive effect with diazepam (Valium) and clonazepam (Klonopin) (3710). This may also occur with other benzodiazepines.
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Theoretically, taking ashwagandha might increase the sedative effects of CNS depressants.
Details
Ashwagandha seems to have sedative effects. Theoretically, this may potentiate the effects of barbiturates, other sedatives, and anxiolytics (3710).
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Theoretically, taking ashwagandha might decrease the effects of immunosuppressants.
Details
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Ashwagandha might increase the effects and adverse effects of thyroid hormone.
Details
Concomitant use of ashwagandha with thyroid hormones may cause additive therapeutic and adverse effects. Preliminary clinical research and animal studies suggest that ashwagandha boosts thyroid hormone synthesis and secretion (19281,19282,97292). In one clinical study, ashwagandha increased triiodothyronine (T3) and thyroxine (T4) levels by 41.5% and 19.6%, respectively, and reduced serum TSH levels by 17.4% from baseline in adults with subclinical hypothyroidism (97292).
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Theoretically, taking GABA with antihypertensive drugs might increase the risk of hypotension.
Details
Some clinical research shows that GABA can decrease blood pressure in patients with hypertension (19367).
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Theoretically, GABA might have additive sedative effects when used in conjunction with CNS depressants. However, it is unclear if this concern is clinically relevant.
Details
Endogenous GABA has well-established relaxant effects (51152) and GABA(A) receptors have an established physiological role in sleep (51143). However, the effects of GABA supplements are unclear, as it is unknown whether exogenous GABA crosses the blood-brain barrier (51120,51153,90570). Although there have been limited reports of drowsiness or tiredness with GABA supplements (5115,19364), these effects have not been widely reported in clinical studies. Additionally, intravenous GABA 0.1-1 mg/kg has been shown to induce anxiety in a dose-dependent manner (5116).
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Theoretically, German chamomile might have additive effects when used with CNS depressants.
Details
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Theoretically, large amounts of German chamomile might reduce the effectiveness of oral contraceptives.
Details
In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, concomitant use of large amounts of German chamomile might interfere with contraceptive drugs through competition for estrogen receptors.
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Theoretically, German chamomile might inhibit CYP1A2 and increase levels of drugs metabolized by these enzymes.
Details
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Theoretically, German chamomile might inhibit CYP2C9 and increase levels of drugs metabolized by these enzymes.
Details
In vitro evidence shows that German chamomile might inhibit CYP2C9 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2C9 in patients taking German chamomile.
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Theoretically, German chamomile might inhibit CYP2D6 and increase levels of drugs metabolized by these enzymes.
Details
In vitro evidence shows that German chamomile might inhibit CYP2D6 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2D6 in patients taking German chamomile.
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Theoretically, German chamomile might inhibit CYP3A4 and increase levels of drugs metabolized by these enzymes.
Details
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Theoretically, large amounts of German chamomile might reduce the effectiveness of estrogens.
Details
In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, large amounts of German chamomile might interfere with hormone replacement therapy through competition for estrogen receptors.
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Theoretically, large amounts of German chamomile might interfere with the activity of tamoxifen.
Details
In vitro, German chamomile has demonstrated antiestrogenic activity (12728).
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German chamomile might increase the effects of warfarin and increase the risk of bleeding.
Details
In one case, a 70-year-old female taking warfarin developed retroperitoneal hematoma and bilateral recti muscle bleeding along with an INR of 7.9 following ingestion of German chamomile tea 4-5 cups daily and use of a topical chamomile-based lotion applied 4-5 times daily (14309).
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Theoretically, lavender might potentiate the therapeutic effects and adverse effects of CNS depressants.
Details
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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Theoretically, concomitant use of lemon balm might have additive effects with CNS depressant drugs.
Details
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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).
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Theanine might lower blood pressure, potentiating the effects of antihypertensive drugs.
Details
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Theoretically, theanine might have additive sedative effects when used in conjunction with CNS depressants. However, it is unclear if this concern is clinically relevant.
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Valerian can have additive sedative effects when used concomitantly with alcohol.
Details
Valerian has sedative effects (9894). Theoretically, valerian might have an additive sedative effect when combined with alcohol. Excessive sedation has been reported in an alcohol-abusing individual who took valerian and Gingko biloba (19426). However, the potential interaction between valerian and alcohol has been disputed in other research. Limited evidence suggests that a combination of valerian 160 mg and lemon balm 80 mg (Euvegal) does not cause further deterioration in reaction ability and reaction rate when taken with alcohol as compared to the effects of alcohol alone (19427).
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Valerian can have additive sedative effects when used with alprazolam. Also, valerian in high doses might modestly increase alprazolam levels, though this is not likely to be clinically significant.
Details
Valerian has sedative effects (9894). Theoretically, valerian might cause additive sedation when combined with alprazolam. Also, a small pharmacokinetic study shows that taking valerian extract 1000 mg daily (providing 11 mg valerenic acid) might increase alprazolam levels by about 19%. This might be due to valerian's mild inhibition of cytochrome P450 3A4 (CYP3A4) (13014). Despite being statistically significant, this increase is not likely to be clinically significant.
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Valerian can have additive sedative effects when used concomitantly with CNS depressant drugs.
Details
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Valerian does not seem to have a clinically relevant effect on levels of drugs metabolized by CYP2D6.
Details
Although some in vitro evidence suggests that valerian affects CYP2D6, clinical pharmacokinetic (PK) studies show that valerian is unlikely to affect the CYP2D6 enzyme (13014,13536,19430,19431). In one PK study, taking valerian 1000 mg (providing about 11 mg valerenic acid) nightly for 14 days did not affect the metabolism of dextromethorphan, a CYP2D6 substrate. In another PK study, taking valerian 125 mg three times daily for 28 days did not affect metabolism of debrisoquine, an accepted CYP2D6 probe-substrate (13014,13536).
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Valerian does not seem to have a clinically relevant effect on levels of drugs metabolized by CYP3A4.
Details
Although some in vitro evidence suggests that valerian extract might inhibit or induce CYP3A4, clinical pharmacokinetic (PK) studies show that valerian does not have a clinically significant effect on the CYP3A4 enzyme (6450,12214,13014,13536,19431). In one PK study, taking valerian 125 mg three times daily for 28 days did not affect metabolism of midazolam, an accepted CYP3A4 probe-substrate. In another PK study, taking valerian 1000 mg (providing about 11 mg valerenic acid) nightly for 14 days modestly increases levels of alprazolam, a CYP3A4 substrate, suggesting mild inhibition of CYP3A4 (13014,13536). However, this mild inhibition is unlikely to be clinically relevant.
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Valerian might weakly inhibit glucuronidation and increase concentrations of drugs metabolized by UGT1A1 and UGT2B7.
Details
In vitro research shows that methanolic valerian extract and valerenic acid might competitively inhibit UDP-glucuronosyltransferase (UGT) 1A1 (UGT1A1) and UGT2B7 (81685).
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Below is general information about the adverse effects of the known ingredients contained in the product Sleep Support. 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, ashwagandha seems to be well-tolerated.
Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal upset, nausea, and vomiting. However, these adverse effects do not commonly occur with typical doses.
Serious Adverse Effects (Rare):
Orally: Some case reports raise concerns about acute liver failure, hepatic encephalopathy, and the need for liver transplantation with ashwagandha treatment.
Dermatologic ...Orally, dermatitis has been reported in three of 42 patients in a clinical trial (19276).
Endocrine ...A case report describes a 73-year-old female who had taken an ashwagandha root extract (unspecified dose) for 2 years to treat hypothyroidism which had been previously managed with levothyroxine. The patient was diagnosed with hyperthyroidism after presenting with supraventricular tachycardia, chest pain, tremor, dizziness, fatigue, irritability, hair thinning, and low thyroid stimulating hormone (TSH) levels. Hyperthyroidism resolved after discontinuing ashwagandha (108745).
Gastrointestinal ...Orally, large doses may cause gastrointestinal upset, diarrhea, and vomiting secondary to irritation of the mucous and serous membranes (3710). When taken orally, nausea and abdominal pain (19276,110490) and gastritis and flatulence (90651) have been reported.
Genitourinary ...In one case report, a 28-year-old male with a decrease in libido who was taking ashwagandha 5 grams daily over 10 days subsequently experienced burning, itching, and skin and mucous membrane discoloration of the penis, as well as an oval, dusky, eroded plaque (3 cm) with erythema on the glans penis and prepuce (32537).
Hepatic ...Orally, ashwagandha in doses of 154-1350 mg daily has played a role in several case reports of liver injury. In most of these cases, other causes of liver injury were excluded, and liver failure did not occur. Symptoms included jaundice, pruritus, malaise, fatigue, lethargy, weight loss, nausea, diarrhea, abdominal pain, stool discoloration, and dark urine. Symptom onset was typically 5-180 days from first intake, although in some cases onset occurred after more than 12 months of use (102686,107372,110490,110491,111533,111535,112111). Laboratory findings include elevated aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, and serum bilirubin (112111). In most cases, liver enzymes normalized within 1-5 months after discontinuation of ashwagandha (102686,107372,110491,111535,112111). However, treatment with corticosteroids, lactulose, ornithine, ursodeoxycholic acid, and plasmapheresis, among other interventions, was required in one case (111533). Rarely, use of oral ashwagandha has been reported to cause hepatic encephalopathy and liver failure requiring liver transplantation (110490).
Neurologic/CNS ...Orally, ashwagandha has been reported to cause drowsiness (110492). Headache, neck pain, and blurry vision have been reported in a 47-year-old female taking ashwagandha, cannabis, and venlafaxine. Imaging over the course of multiple years and hospital admissions indicated numerous instances of intracranial hemorrhage and multifocal stenosis of intracranial arteries, likely secondary to reversible cerebral vasoconstriction syndrome (RCVS) (112113). It is unclear whether the RCVS and subsequent intracranial hemorrhages were precipitated by ashwagandha, cannabis, or venlafaxine.
General
...Orally, GABA seems to be generally well tolerated.
Sublingually, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Drowsiness, gastric upset, minor throat burning, muscle weakness, and nausea.
Cardiovascular ...Intravenously, GABA can cause dose-related increases in blood pressure and pulse (5116).
Gastrointestinal ...Orally, minor throat burning has been associated with GABA in one study (5115). In another study in which GABA was administered with phosphatidylserine, one patient experienced severe gastric distress, two patients reported moderate nausea, and one reported constipation (19364). Children with cerebral palsy taking GABA experienced nausea and decreased appetite (19362).
Genitourinary ...In one study, one patient treated with oral GABA and phosphatidylserine reported transient amenorrhea (19364).
Musculoskeletal ...Orally, minor adverse effects associated with GABA included muscle weakness (5115).
Neurologic/CNS ...Orally, GABA may cause drowsiness or tiredness (5115,19364). Four children with cerebral palsy taking GABA had convulsions, and an unspecified number experienced motor restlessness. However, causality of these adverse effects was not clear, and the dose of GABA was not specified (19362). Intravenously, GABA 50 mg has been associated with a "lack of alertness" in healthy female volunteers (51159).
Psychiatric ...Intravenously, GABA 0. 1-1.0 mg/kg has been shown to induce anxiety, dysphoria, and mood disturbances in a dose-dependent manner (5116).
Other ...In one study, patients taking GABA experienced a slight warming of the body (19370).
General
...Orally and topically, German chamomile is well tolerated.
Most Common Adverse Effects:
Orally and topically: Allergic reactions and irritation.
Dermatologic ...Topically, German chamomile may cause allergic dermatitis and eczema (9766,9768,10377,110318).
Gastrointestinal ...When used topically as an oral rinse, German chamomile has been reported to cause nausea and burning in the mouth in some patients (99853).
Immunologic ...Orally, German chamomile tea can cause allergic reactions including severe hypersensitivity reactions and anaphylaxis in some patients (567). In one case report, a 47-year-old female who tolerated drinking chamomile tea, reported sneezing, nasal and ocular itching, red and watery eyes, and severe rhinorrhea after 10 years of occupational exposure to German chamomile dust (90542).
Ocular/Otic ...If used near the eyes, German chamomile can cause irritation (10377).
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).
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).
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, 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).
General
...Orally, valerian is generally well-tolerated.
Most Common Adverse Effects:
Orally: Dizziness, drowsiness, and mental slowness. Other reported side effects include headache, gastrointestinal upset, excitability, and vivid dreams. When used chronically and abruptly stopped, symptoms of withdrawal such as tachycardia, anxiety, irritability, and insomnia might occur. Advise patients to taper doses slowly after extended use.
Serious Adverse Effects (Rare):
Orally: Several case reports raise concerns about hepatotoxicity after the use of valerian and valerian-containing multi-ingredient dietary supplements. Withdrawal from chronic valerian use has been associated with cases of cardiac failure and hallucinations.
Cardiovascular ...When used orally in high doses for an extended period of time, valerian withdrawal has been associated with tachycardia and high output cardiac failure in one patient with a history of coronary artery disease (3487). Chest tightness has been reported for an 18-year-old female who took 40-50 capsules containing valerian 470 mg/capsule (659). A case of severe hypotension, suspected to be due to vasodilation, hypocalcemia, and hypokalemia, has been reported for a patient who injected an unknown quantity of a crude tap water extract of raw valerian root (81734).
Dermatologic ...Orally, valerian might rarely cause a rash. A case of valerian-related rash that resolved after valerian root discontinuation was reported in clinical research (19422).
Gastrointestinal ...Orally, valerian has been associated with increased incidence of gastrointestinal problems including diarrhea, nausea, vomiting, and stomach pain (15046,19406,19407,19422,110712). In one individual, taking 20 times the normal dose caused abdominal cramping (659).
Hepatic
...There have been several case reports of hepatotoxicity associated with the use of multi-ingredient oral preparations containing valerian (8243,96241).
In one case report, a 57-year-old man presented with acute hepatitis after consuming a cold and flu remedy containing valerian 2 grams for 3 days; the remedy also contained white willow, elderberry, and horseradish. Although the use of the cold and flu remedy was discontinued one month prior to symptom presentation, the acute hepatitis was attributed to valerian root and treated with steroids (96241). It is possible, however, that some of these preparations may have been adulterated with hepatotoxic agents (8243).
Hepatotoxicity involving long-term use of single-ingredient valerian preparations has also been reported (3484,17578). Also, a case of a 38-year-old female with liver insufficiency and cirrhosis of a vascular parenchymal nature who developed hepatotoxic symptoms following valerian and ethyl-alcohol abuse has been reported (81697). Symptoms resolved and laboratory values normalized following intense plasmapheresis treatment. Another case of acute hepatitis characterized by elevated aminotransferases, mild fibrosis, and liver inflammation has been reported for a 50-year-old female who consumed valerian root extract 5 mL three times weekly along with 10 tablets of viamine, a product containing dry valerian extract 125 mg/tablet, for 2 months (81696). Because a variety of doses were used in these cases, and many people have used higher doses safely, these hepatotoxic reactions might have been idiosyncratic. Tell patients the long-term effect of valerian on liver function is unknown.
Musculoskeletal ...In a case report, combined intake of valerian and passionflower caused throbbing and muscular fatigue when taken concomitantly with lorazepam (19429).
Neurologic/CNS ...Orally, valerian might cause dizziness, headaches, fatigue, sleepiness, and mental dullness (3484,17578,19411,19422,81723,89407). The severity of adverse effects appears to increase with higher doses (19411). However, taking valerian extracts in doses up to 1800 mg does not appear to significantly affect mood or psychomotor performance (10424,15044). Valerian does not usually have a negative impact on reaction time, alertness, and concentration the morning after intake (2074,8296). Clinical research shows that a single dose of valerian root 1600 mg is not associated with any changes in sleepiness, reaction time, or driving performance within 1-4 hours after intake (96240). More serious side effects may occur when valerian is taken at higher doses. In one individual, 20 times the normal dose caused tremor of the hand and foot and lightheadedness (659). In a case report, combined intake of valerian and passionflower caused shaking of the hands and dizziness when taken concomitantly with lorazepam (19429).
Psychiatric ...Orally, valerian has been associate with reports of restlessness, excitability, uneasiness, agitation, and vivid dreams (3484,17578,19411,19422). Chronic use and rapid cessation can lead to withdrawal syndrome with symptoms of agitation, insomnia, and hallucinations (104003). There appears to be a trend towards increased severity of adverse effects with higher doses (19411). A case of acute hypomania has been reported for a 21-year-old female patient who took a valerian decoction in water each night for one month to treat subclinical anxiety. Symptoms included euphoric mood, rapid speech, and increased sociability and sexual interest. Following cessation of valerian use and treatment with quetiapine 100 mg daily for two weeks, the patient recovered (89405). In another case report, an 85-year-old male with mild cognitive impairment, major depression, anxiety, and chronic kidney disease presented to the emergency department with hallucinations, confusion, and agitation thought to be due to abrupt cessation after taking valerian 600 mg daily for about 6 months. The symptoms resolved in about 5 days (104003).