Melatonin With Vitamin B-6 (melatonin/pyridoxal phosphate)
Vitamin B-6 Sublingual Tablet, Sublingual
Last reviewed · Source: First Databank (FDB) drug data
Overview
USES: Melatonin has been used for trouble sleeping (insomnia). This product may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer time.
Melatonin is a substance that your body normally makes. It is thought to help your body's regular daily cycle, hormone production, and sleep patterns. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives.
Check with your pharmacist for more details regarding the particular brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
Generic name: melatonin/pyridoxal phosphate
Drug class: Vitamin B-6
Therapeutic class: Central Nervous System Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Melatonin With Vitamin B-6
Indications
No indications are available for this drug.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Melatonin/Strong Cyp1a2 Inhibitors
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Strong CYP1A2 inhibitors may significantly increase the area-under-curve (AUC) of melatonin by inhibiting CYP1A2.(1,2) Fluvoxamine, a strong CYP1A2 inhibitor, has also been shown to increase endogenous melatonin levels.
CLINICAL EFFECTS: The concurrent administration of melatonin and strong CYP1A2 inhibitors may result in significantly increased melatonin levels and subsequent side effects.(1-3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The UK manufacturer of melatonin recommends against the concurrent use of melatonin and CYP1A2 inhibitors.(1) The Australian manufacturer of melatonin states concurrent use of melatonin and CYP1A2 inhibitors should be avoided.(2) Patients should be monitored for increased effects of melatonin when melatonin and CYP1A2 inhibitors are used concurrently.
DISCUSSION: In a study, fluvoxamine increased the area-under-curve (AUC) and concentration maximum (Cmax) of melatonin by 17-fold and 12-fold, respectively.(2) In a case report, a 51 year old female with chronic primary insomnia who received 5 mg melatonin at bedtime and 75 mg fluvoxamine in the afternoon experienced increased nocturnal sleep, from 2.5 hours (drug free) to 4.2 hours (melatonin alone) up to 5.5 hours per night (melatonin with fluvoxamine). Both melatonin and fluvoxamine alone increased melatonin levels; however administration of melatonin alone increased melatonin levels more than fluvoxamine alone. Concurrent use of melatonin and fluvoxamine increased melatonin levels 20-fold when compared to the administration of melatonin alone.(3) In a study involving five males, 5 mg of melatonin daily was given for one week, then 50 mg of fluvoxamine was added (administered three hours apart. The AUC of melatonin increased at least nine-fold (p<0.05). The Cmax increased at least six-fold in melatonin (p<0.01), versus the Cmax in patients who received melatonin alone.(4) Strong CYP1A2 inhibitors include: enasidenib, fluvoxamine, and viloxazine.(5)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Pyridoxine/Levodopa
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Pyridoxine increases levodopa metabolism, decreasing the amount of levodopa available to the central nervous system.
CLINICAL EFFECTS: The pharmacologic effects of levodopa may be decreased.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Avoid pyridoxine in patients receiving levodopa alone; however, the interaction can be minimized by giving levodopa with a peripheral decarboxylase inhibitor (e.g. carbidopa, benserazide). Treatment with combination carbidopa-levodopa may contribute to reduced vitamin B6 levels. Higher doses of carbidopa-levodopa may increase the risk of vitamin B6 deficiency. Seizures associated with vitamin B6 deficiency have been reported in the postmarketing setting. In patients taking combination therapy with carbidopa/levodopa, evaluate vitamin B6 levels periodically while on treatment or if symptoms associated with vitamin B6 deficiency are identified. Supplement with vitamin B6 as necessary.
DISCUSSION: In patients with Parkinson's disease, as little as 10 mg of pyridoxine may reverse the clinical benefits as well as the adverse effects of levodopa. Coadministration of levodopa with either carbidopa or benserazide has minimized the effects of this interaction.
Contraindications
There is no enhanced messaging for this drug.
There are no contraindication contraindications for this drug.
- Autoimmune disease
- Systemic lupus erythematosus
There are no moderate contraindications for this drug.
Adverse reactions
There is no enhanced messaging for this drug.
There are no severe adverse reactions for this drug.
More Frequent
- Dizziness
- Headache disorder
- Sedation hangover effect
Less Frequent
- Abdominal pain with cramps
- Acute cognitive impairment
- CNS depression
- Concentration difficulty
- Depression
- Hypotension
- Irritability
- Nausea
- Symptoms of anxiety
- Tremor
- Vomiting
Rare or Very Rare
- Panic disorder
Precautions
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.