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Important Safety Information

Recharge (Compounded Ramelteon, Doxylamine, and Valerian Root Oral Tablet)

Recharge is a compounded medication, and although it is formulated from certain active ingredients that have been approved by the FDA for certain indications, Recharge isNOT FDA-approved and does NOT undergo FDA review for safety, effectiveness, or quality for any indication.

Recharge is ONLY intended for use as a sleep aid by people 18 to 64 years of age.

About the Active Ingredients

Ramelteon

Ramelteon is a prescription melatonin agonist medication used in the treatment of insomnia. It is FDA-approved for the treatment of insomnia characterized by difficulty with sleep onset.

Doxylamine

Doxylamine is an over-the-counter antihistamine medication used in the treatment of occasional sleeplessness. It is FDA-approved for the treatment of occasional sleeplessness and allergy symptoms.

Valerian Root

Valerian root is a supplement added to Recharge for support. Because Recharge contains valerian root:

  • DO NOT take Recharge if you have an allergy to valerian root.
  • DO NOT take Recharge without consulting your healthcare provider if you have a history of liver disease.
  • DO NOT use Recharge if you are pregnant or breastfeeding.
  • AVOID taking Recharge with alcohol or other sedatives.
  • DO NOT drive or operate machinery after taking Recharge.

General Warning

IMPORTANT: This is a summary and does not include all possible safety information about this product. By providing this information, we are not assuring that this product is safe, effective, or appropriate for you.

This information is not individual medical advice and is not a substitute for the advice of your healthcare professional. Always ask your healthcare professional for complete information about this product and your specific health needs before taking this product.

Reference Information

The following information regarding Ramelteon was primarily obtained from the prescribing information forRozerem® (ramelteon tablets), which can be found here:FDA Label for Rozerem® (PDF).

Ramelteon Information

Contraindications

  • History of anaphylaxis or angioedema while taking ramelteon.
  • Use with fluvoxamine (a strong CYP1A2 inhibitor) — increases AUC for ramelteon and should not be used in combination.

Warnings and Precautions

  • Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.
  • Abnormal thinking, behavioral changes, complex behaviors: May include “sleep-driving” and hallucinations. Immediately evaluate any new onset behavioral changes.
  • Depression: Worsening of depression or suicidal thinking may occur.
  • CNS effects: Potential impairment of activities requiring complete mental alertness (e.g., operating machinery, driving).
  • Reproductive effects: Decreased testosterone and increased prolactin levels observed. Effect on developing humans is unknown.
  • Severe sleep apnea: Not recommended for use in this population.

Side Effects

Common (≥3% and more common than placebo): somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.

Serious (rare): hallucinations, confusion, agitation/mania, anaphylaxis/angioedema, suicidal thoughts, and complex sleep behaviors.

To report suspected adverse reactions, contact the FDA at1-800-FDA-1088 or visitwww.fda.gov/medwatch.

Drug Interactions

  • Rifampin: Decreases exposure/effect of ramelteon.
  • Ketoconazole: Increases AUC for ramelteon; use with caution.
  • Fluconazole: Increases systemic exposure; use with caution.
  • Donepezil: Increases systemic exposure; monitor closely.
  • Doxepin: Increases systemic exposure; monitor closely.
  • Alcohol: Causes additive psychomotor impairment; avoid combination.

Use in Specific Populations

  • Pediatric: Safety and effectiveness not established.
  • Geriatric: No overall differences in safety or efficacy between elderly and younger adults.
  • Hepatic impairment: Not recommended in severe impairment; use with caution in moderate impairment.
  • Pregnancy and lactation: Do not use if pregnant or breastfeeding.

Doxylamine Information

Contraindications

  • History of hypersensitivity/allergy to doxylamine or other antihistamines.
  • Use of a monoamine oxidase inhibitor (MAOI) within the past 14 days.

Warnings and Precautions

  • DO NOT use with other products containing doxylamine or any other antihistamine.
  • USE ONLY when a full night’s sleep is possible (may cause next-day drowsiness).
  • DO NOT drive or operate machinery after dosing.
  • AVOID taking with alcohol or other sedatives.
  • USE WITH CAUTION if you have:
    • Glaucoma
    • Difficulty urinating due to enlarged prostate (BPH)
    • Stenosing peptic ulcer or pyloroduodenal obstruction
    • Respiratory disease (asthma, emphysema, chronic bronchitis)

Side Effects

Common: drowsiness, dry mouth, dizziness, blurred vision, constipation, difficulty urinating, headache, nausea, upset stomach.

Serious (rare): confusion, hallucinations, delirium (especially in elderly), agitation/excitement (especially in children), tachycardia, difficulty breathing, acute angle-closure glaucoma.

To report suspected adverse reactions, contact the FDA at1-800-FDA-1088 or visitwww.fda.gov/medwatch.

Drug Interactions

  • Additive CNS depression/drowsiness: With sedatives, sleep aids, antihistamines, opioids, antidepressants, and alcohol.
  • Additive anticholinergic effects: With other anticholinergic drugs, antihistamines, antidepressants, and MAOIs.

Use in Specific Populations

  • Pediatric: Not intended for pediatric use.
  • Geriatric: Use with caution in patients over 65 due to increased risk of confusion, hallucinations, delirium, falls, and anticholinergic effects.
  • Pregnancy and lactation: Do not use if breastfeeding.