What is Recharge?

Recharge is a compounded medication combining three active ingredients: ramelteon, doxylamine, and valerian root. It is intended only for adults ages 18 to 64 as a sleep aid.

Important: Recharge is a compounded medication. Although its ingredients have been FDA-approved for other uses, Recharge itself is NOT FDA-approved and has not been reviewed by the FDA for safety, effectiveness, or quality for any use.

• Ramelteon is a prescription medication that works like melatonin to help you fall asleep. It is FDAapproved for treating insomnia (difficulty falling asleep).
• Doxylamine is an over-the-counter antihistamine that causes drowsiness. It is FDA-approved for occasional sleeplessness and allergy symptoms.
• Valerian root is an herbal supplement included to support relaxation and sleep.

Note: This summary does not contain all possible safety information. It is not a substitute for advice from your healthcare provider. Always talk to your doctor or pharmacist before taking this medication.

Who Should NOT Take Recharge

Do not take Recharge if you:

• Have had a severe allergic reaction (swelling of face/throat or difficulty breathing) to ramelteon, doxylamine, other antihistamines, or valerian root
• Are taking fluvoxamine (Luvox)—this antidepressant significantly increases ramelteon levels in your body
• Have taken MAO inhibitors (a type of antidepressant) within the past 14 days
• Are pregnant or breastfeeding
• Have severe liver disease
• Have severe sleep apnea

Important Warnings

Drowsiness and Impairment

DO NOT drive, operate machinery, or perform activities requiring full alertness after taking Recharge.

• This medication is designed to make you drowsy—take it only when you can get a full night's sleep.
• Drowsiness may continue into the next day.

Alcohol and Sedatives

• Do NOT drink alcohol while taking Recharge—it increases drowsiness and impairment.
• Do NOT combine with other sedatives, sleep aids, antihistamines, or opioid pain medications without talking to your doctor.

Complex Sleep Behaviors

• In rare cases, sleep medications can cause unusual behaviors while you are not fully awake, such as:
  • Sleepwalking
  • Sleep-driving
  • Making phone calls or eating while asleep
  • Not remembering these activities
• Stop taking Recharge and contact your doctor immediately if you experience any of these behaviors

Mental Health Effects

• Recharge may cause abnormal thinking, behavior changes, or hallucinations.
• Depression may worsen, and suicidal thoughts may occur in some patients.
• Contact your doctor immediately if you experience mood changes, unusual thoughts, or worsening depression

Severe Allergic Reactions

• In rare cases, ramelteon can cause severe allergic reactions including swelling of the face, tongue, or throat (angioedema) and difficulty breathing (anaphylaxis).
• Seek emergency medical help immediately if you experience these symptoms.
• Do not take Recharge again if you have had a severe allergic reaction to it

Hormone Effects

• Ramelteon may affect hormone levels, including decreased testosterone and increased prolactin.
• Talk to your doctor if you have concerns about reproductive health.

Other Precautions

Talk to your doctor before taking Recharge if you have:

• Liver problems (not recommended for severe liver disease; use with caution for moderate liver problems)
• Glaucoma or eye pressure problems
• An enlarged prostate or trouble urinating
• Stomach ulcers or digestive blockages
• Breathing problems such as asthma, emphysema, or chronic bronchitis
• Sleep apnea
• A history of depression or mental health conditions

Drug Interactions

Tell your doctor about all medications you take, especially:

Common Side Effects

From Ramelteon:

• Drowsiness
• Dizziness
• Fatigue
• Nausea
• Worsened insomnia (in some cases)

From Doxylamine:

• Drowsiness
• Dry mouth
• Dizziness
• Blurred vision
• Constipation
• Difficulty urinating
• Headache
• Nausea or upset stomach

Rare but Serious Side Effects

Seek medical attention if you experience:

• Hallucinations or confusion
• Agitation or unusual excitement
• Severe allergic reaction (swelling of face/lips/tongue/throat, difficulty breathing, hives)
• Rapid heartbeat
• Difficulty breathing
• Eye pain or vision changes (may indicate glaucoma)
• Suicidal thoughts or worsening depression
• Complex sleep behaviors (sleepwalking, sleep-driving, etc.)

Special Populations

This medication is NOT for:

• Anyone under 18 years old
• Anyone 65 years or older (increased risk of confusion, falls, and side effects)
• Pregnant or breastfeeding individuals (can cause harm to babies)

Use with caution if you have:

• Moderate liver problems: Use with caution; not recommended for severe liver disease
• Severe sleep apnea: Not recommended

Older adults (65+):

• Recharge is not intended for adults over 64 years of age due to increased risk of confusion, hallucinations, delirium, and falls from the antihistamine component.

Reporting Side Effects

If you experience any serious or unexpected side effects, report them to the FDA:

• Phone: 1-800-FDA-1088
• Online: www.fda.gov/medwatch