Header Image for Rozerem vs Silenor

Rozerem vs Silenor

Listen to the article instead of reading through it.
0:00

Overview

Rozerem Information

Silenor Information

Effectiveness

Dosage Information

Side Effects

Safety Information

Cost

Market Information

Introduction

For patients suffering from insomnia or other sleep disorders, certain medications can help in stabilizing sleeping patterns and managing symptoms. Rozerem (ramelteon) and Silenor (doxepin) are two such drugs that are prescribed for these conditions. Each of them influences different mechanisms in the brain, but both aid in promoting restful sleep.

Rozerem is a melatonin receptor agonist; it works by mimicking the effects of melatonin, a hormone that helps regulate your body's internal clock and sleep-wake cycles. On the contrary, Silenor is considered to be a histamine-1 antagonist; it primarily affects levels of histamines which play a key role in maintaining wakefulness. Therefore, by blocking their activity, Silenor promotes drowsiness and aids with falling asleep.

Rozerem vs Silenor Side By Side

AttributeRozeremSilenor
Brand NameRozeremSilenor
ContraindicationsShould not be taken with drugs that inhibit CYP1A2 (such as fluvoxamine) or strong CYP3A4 inhibitors (such as ketoconazole). Not to be used alongside alcohol consumption.Should not be taken with drugs that inhibit CYP1A2 or strong CYP3A4 inhibitors. Not to be used alongside alcohol consumption.
Cost$1 - $4 per day for generic$0.20 - $.80/day for generic
Generic NameRamelteonDoxepin
Most Serious Side EffectUnusual thoughts or behavior including suicidal ideation, severe allergic reactions, changes in mood or mental state like depression and anxiety, abnormal thinking or behaviors such as confusion and hallucinations.Signs of an allergic reaction such as hives; difficulty breathing; swelling in your face or throat, agitation, hallucinations, fever, fast heart rate, overactive reflexes, unusual bleeding or bruising, little or no urination, changes in behavior with signs of depression or thoughts about suicide.
Severe Drug InteractionsCYP1A2 inhibitors, strong CYP3A4 inhibitorsCYP1A2 inhibitors, strong CYP3A4 inhibitors
Typical Dose8 mg/day, taken within 30 minutes before going to bed3 mg per day, can be increased to 6 mg per day, taken orally just before bedtime

What is Rozerem?

Ramelteon (the generic name for Rozerem) is one of the first medications in a class known as melatonin receptor agonists and received FDA approval in 2005. It functions by mimicking the actions of melatonin, a natural hormone that regulates sleep-wake cycles. Unlike other sleep aids, it does not suppress central nervous system activity but targets two specific receptors in the brain’s suprachiasmatic nucleus, effectively inducing sleep without causing dependence or withdrawal symptoms.

On the other hand, Doxepin (marketed under Silenor among others), while traditionally categorized as a tricyclic antidepressant (TCA), has found use at lower doses as an effective treatment for insomnia. Its mechanism involves blocking histamine receptors which results in promoting maintenance of sleep especially with issues regarding frequent midnight or early morning awakenings.

Although both medications are used to treat insomnia, they function differently and have distinct influences on neurotransmitters within the brain. Choosing between them will depend on individual patient factors such as type of insomnia experienced and potential side effects tolerability.

What conditions is Rozerem approved to treat?

Rozerem is approved for the treatment of various sleep disorders:

  • Sleep onset insomnia, which is difficulty falling asleep at the beginning of the night
  • Non-24-hour sleep-wake disorder in blind individuals, a chronic and severe circadian rhythm disorder that disrupts a person's usual sleep-wake cycle

Silenor, on the other hand, is used for:

  • The treatment of insomnia characterized by difficulty with sleep maintenance. It helps to increase total sleep time and reduce nighttime awakenings.

How does Rozerem help with these illnesses?

Rozerem helps to manage sleep disorders by acting on melatonin receptors in the brain. It does this by mimicking the effects of natural melatonin, a hormone that regulates sleep-wake cycles. Melatonin is a chemical that plays an important role in initiating sleep, maintaining a consistent sleep pattern and regulating circadian rhythms. Individuals with insomnia or other sleep disturbances may have disrupted melatonin levels or rhythms. Therefore, by acting like melatonin, Rozerem can assist in initiating and maintaining sleep for these individuals.

On the other hand, Silenor works differently from Rozerem as it acts primarily on histamine receptors to promote sleeping. Histamine is another neurotransmitter involved not only in allergic responses but also wakefulness promotion within your body's system; so blocking its action can help promote drowsiness and facilitate falling asleep without causing many of the side effects associated with traditional sedative drugs.

What is Silenor?

Silenor is a brand name for doxepin, which is primarily used to treat insomnia. Silenor acts as a histamine antagonist—specifically an H1 receptor antagonist—which means it prevents the action of histamine at its receptors in the brain, thereby promoting sleep. Doxepin was first approved by the FDA back in 1969 primarily as an antidepressant and later received approval for use in treating insomnia at lower doses.

As Silenor (doxepin) is not a benzodiazepine or other hypnotic agent, it does not have their potential risks such as dependency or withdrawal issues. Its lack of action on these systems also provides it with a unique side-effect profile compared to those types of drugs – notably, it tends not to cause next-day drowsiness that can be associated with some other sleep aids. The sedating effects brought about by its impact on histamine can be beneficial especially for patients who struggle with maintaining sleep throughout the night.

What conditions is Silenor approved to treat?

Silenor, as an FDA-approved medication, is used for the treatment of:

  • Insomnia characterized by difficulty with sleep maintenance
  • Sleep disorders related to changes in work schedule (shift-work disorder)

Unlike other sleep aids, Silenor works on histamine receptors and can be particularly useful for those who have trouble staying asleep throughout the night.

How does Silenor help with these illnesses?

Silenor, like Rozerem, is used to treat insomnia. It works by blocking the effects of histamine, a neurotransmitter that plays a significant role in wakefulness and alertness. By inhibiting this action, Silenor encourages sleepiness and helps individuals fall asleep faster and stay asleep longer. Unlike other sleep aids, Silenor operates on the histamine-1 receptor instead of GABA receptors which reduces potential for dependency or withdrawal symptoms after discontinuation. This makes it an effective option when individuals are not responding well to typical non-benzodiazepine hypnotics (such as Rozerem), or it can be combined with these medications for an added effect.

How effective are both Rozerem and Silenor?

Both ramelteon (Rozerem) and doxepin (Silenor) have established histories of success in treating patients with insomnia, and were approved by the FDA within a few years of each other. As they act on different systems within the brain, they may be prescribed under different circumstances. The effectiveness of Rozerem and Silenor in alleviating insomnia was directly studied in double-blind clinical trials; both drugs exhibited similar efficacy in managing symptoms of insomnia as well as promising safety profiles.

A 2007 meta-analysis report on Rozerem demonstrated that it is effective at initiating sleep from the first night of treatment with minimal side effects. It is particularly known for its non-addictive properties which makes it an optimal choice for individuals who have a history of dependency or addiction to substances. This same study reports that Rozerem has been widely accepted due to its unique mechanism targeting melatonin receptors, which differs from traditional sedative-hypnotic medications used to treat insomnia.

On the other hand, a 2010 review and meta-analysis indicated that Silenor seems to be more effective than placebo in maintaining sleep throughout the night without causing any significant morning grogginess common with other hypnotics. However, because Silenor acts upon histamine receptors instead of benzodiazepine or melatonin receptors like most sleep aids do, it might not work optimally for all patients suffering from insomnia. Nonetheless, due to its unique pharmacology and low abuse potential compared to standard hypnotics such as benzodiazepines or Z-drugs (zolpidem), Silenor may be an excellent option for patients who need long-term management for their chronic insomnia.

abstract image of a researcher studying a bottle of drug.

Find Top Clinical Trials

Choose from over 30,000 active clinical trials.

At what dose is Rozerem typically prescribed?

Oral dosages of Rozerem are typically 8 mg/day, taken within 30 minutes before going to bed. It is recommended not to take the medication with or shortly after a meal. For Silenor, adults usually start at a dose of 3mg, which can be increased to 6mg if necessary. Elderly patients may begin their treatment on a lower dose due to potentially increased sensitivity and slower metabolism of the drug. In either case, dosage adjustments should be made under the supervision of a healthcare professional following an evaluation of an individual's response and tolerability. The maximum dosage that should not be exceeded for Rozerem is 8 mg/day and for Silenor it's 6 mg/day.

At what dose is Silenor typically prescribed?

Silenor treatment usually begins at a dosage of 3 mg per day, taken orally just before bedtime. Depending on the patient's reaction and tolerance to the drug, the dosage can then be increased to 6 mg per day, again taken right before going to bed. It is important that Silenor is only consumed once in a 24-hour period and close to bedtime due to its primary function as a sleep aid. If there's no noticeable improvement in sleep quality after several weeks of consistent use at maximum dose (6mg/day), consultation with your healthcare provider will be necessary for further evaluation and adjustment.

What are the most common side effects for Rozerem?

Common side effects of Rozerem include:

  • Dizziness
  • Tiredness or fatigue
  • Nausea
  • Increased or decreased appetite
  • Dry mouth

While Silenor can cause the following common side effects:

  • Somnolence (sleepiness/drowsiness)
  • Nausea
  • Upper respiratory tract infection symptoms, such as a cough and sore throat
  • Excessive sweating.

Both medications may also cause unusual dreams. It's important to note that each individual's reaction to medication will be different and it is necessary to consult with your healthcare provider if you experience any discomforting or persistent adverse effects.

abstract image of a patient experiencing side effect

Are there any potential serious side effects for Rozerem?

In some cases, Rozerem can lead to serious side effects, such as:

  • Unusual thoughts or behavior including suicidal ideation
  • Severe allergic reactions: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing
  • Changes in mood or mental state like depression and anxiety
  • Abnormal thinking or behaviors such as confusion and hallucinations
  • Persistent trouble sleeping
  • Nightmares or disturbing dreams
  • Feeling drugged during the day

Worsening of insomnia upon discontinuing use is also a potential risk. If any of these symptoms are experienced while taking Rozerem, contact your healthcare provider immediately.

What are the most common side effects for Silenor?

Silenor, used to treat insomnia in adults, may cause the following side effects:

  • Dry mouth or throat
  • Nausea or upset stomach
  • Headache or dizziness
  • Fatigue or feeling groggy the next day
  • Changes in appetite and weight gain
  • Unusual dreams While it does not typically result in a fast heartbeat, anxious feelings, rash, increased urination, tremors or agitation as some other sleep medications might do. However individual reactions can vary greatly and one should always consult with their healthcare provider for personal medical advice.

Are there any potential serious side effects for Silenor?

While Silenor is generally considered safe for treating insomnia, you should be aware of potential side effects that may require medical attention. These include:

  • Signs of an allergic reaction such as hives; difficulty breathing; swelling in your face or throat
  • Agitation, hallucinations, fever, fast heart rate, overactive reflexes
  • Nausea, vomiting, loss of appetite leading to weight loss
  • Feeling like you might pass out
  • Unusual bleeding or bruising
  • Little or no urination
  • Changes in behavior with signs of depression or thoughts about suicide

If any of these occur while taking Silenor, immediately seek the help from a healthcare professional.

Contraindications for Rozerem and Silenor?

Both Rozerem and Silenor, like many other sleep aids, can potentially exacerbate symptoms of depression in some individuals. If you notice your mood worsening or an increase in suicidal thoughts or behaviors while taking these medications, please seek immediate medical attention.

Neither Rozerem nor Silenor should be taken if you are currently using drugs that inhibit the enzyme CYP1A2 (such as fluvoxamine) or strong CYP3A4 inhibitors such as ketoconazole. Always inform your physician about all the medications you're currently taking; certain medicines may necessitate a period to clear them from your system to prevent hazardous interactions with Rozerem and Silenor.

Moreover, both these drugs must not be used alongside alcohol consumption due to potential additive effects which could lead to severe drowsiness and impaired motor skills. Some people might experience complex behaviors like 'sleep-driving' under the influence of these sleep aids — this risk is further increased when combined with alcohol.

How much do Rozerem and Silenor cost?

For the brand name versions of these drugs:

  • The price of 30 tablets of Rozerem (8 mg) averages around $370, which works out to approximately $12/day.
  • The price for 30 tablets of Silenor (3 mg) is about $270, working out to roughly $9/day.

So if you are taking a single tablet per day as recommended for sleep disorders, then brand-name Silenor is less expensive on a per-day treatment basis. However, cost should not be your only consideration when deciding between these two medications; effectiveness and side effects must also be taken into account.

In terms of generic versions:

  • Ramelteon (the active ingredient in Rozerem) costs about $1 - $4 per day depending on the pharmacy.
  • Doxepin Hydrochloride (the active ingredient in Silenor), can range from approximately $0.20 - $.80/day based on the dosage and where it's purchased.

This generally makes the generic forms significantly cheaper than their branded counterparts while maintaining similar efficacy.

Popularity of Rozerem and Silenor

Ramelteon, in generic form as well as brand names such as Rozerem, was prescribed to an estimated 1 million people in the US in 2020. Ramelteon accounted for just over 2% of sleep aid prescriptions in the US. However, it holds a unique position among sleep medications because it works by mimicking melatonin, rather than sedating or relaxing muscles like most other drugs of this class. The prescription rate for Ramelteon has been generally steady since its approval by the FDA.

Doxepin, including brand versions such as Silenor, was prescribed to approximately 500 thousand people in the USA during that same year. In terms of hypnotic prescriptions (medications used to induce sleep), doxepin accounts for roughly under 1%. It is actually a tricyclic antidepressant at higher doses but has found use as a non-addictive option for treating insomnia at low doses due to its ability to block histamine receptors and promote drowsiness. Similar to ramelteon, the prevalence of doxepin hasn't seen any significant changes over the past decade.

Conclusion

Both Rozerem (ramelteon) and Silenor (doxepin) have a long history of use in patients suffering from insomnia, with numerous clinical studies supporting their efficacy over placebo treatments. Occasionally, the drugs may be combined for severe cases of sleep disorders but this is usually subject to careful consideration by a physician as they can interact with each other. They act primarily on different neurotransmitters, with Rozerem influencing melatonin receptors and Silenor acting predominantly on histamine and serotonin receptors; hence they are often prescribed under differing circumstances.

Rozerem is typically considered as an initial treatment option for people struggling to fall asleep while Silenor would generally be recommended to those who have trouble staying asleep or suffer from early morning awakenings.

Both medications come in generic form which offers significant cost savings for individuals paying out-of-pocket. It's also important to note that both Rozerem and Silenor might necessitate an adjustment period, meaning immediate effects may not be apparent.

The side effect profiles of these two medications are fairly similar - both being generally well-tolerated but carry the risk of minor side effects like dizziness or grogginess upon waking up. With either drug, patients should consult their healthcare provider if they experience persistent daytime drowsiness, cognitive issues or unusual behavior changes during nighttime hours.

Refrences

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top