Belsomra

Insomnia Treatment

Belsomra is primarily used to treat insomnia in adults. Insomnia is a sleep disorder where a person has trouble with the quality or duration of their sleep. This medication is specifically indicated for two main types of sleep issues:

• Sleep onset insomnia: Difficulty falling asleep at the beginning of the night.
• Sleep maintenance insomnia: Difficulty staying asleep throughout the night or waking up too early and being unable to return to sleep.

By addressing both the ability to fall asleep and the ability to remain asleep, the medication aims to help individuals achieve a more complete night of rest. It is intended for use only when a person has enough time to stay in bed for a full night before needing to be active again.

How Belsomra Affects the Brain

Belsomra is classified as an orexin receptor antagonist. It works differently than many traditional sleep aids by targeting the brain's wake-promoting system rather than simply acting as a general sedative.

The brain naturally produces chemicals called orexins, which are responsible for keeping you alert and awake. Belsomra attaches to the receptors for these chemicals and blocks their activity. By quieting the signals that keep you awake, the medication helps to:

• Decrease the time it takes to fall asleep.
• Minimize nighttime awakenings.
• Increase the total duration of sleep.

While the exact way it improves sleep is attributed to this blocking of orexin receptors, it is designed to specifically interfere with the chemical signals that maintain wakefulness.

Common Side Effects

The most frequently reported side effect of Belsomra is sleepiness or grogginess the day after taking the medication. Other common side effects may include:

• Headache
• Dizziness
• Diarrhea
• Dry mouth
• Upper respiratory tract infection or cough
• Unusual or vivid dreams

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following serious side effects:

• Complex sleep behaviors, such as sleep-walking, sleep-driving, preparing and eating food, or making phone calls while not fully awake
• New or worsening depression or suicidal thoughts
• Hallucinations (seeing or hearing things that are not there)
• Sleep paralysis, which is a temporary inability to move or talk for several minutes while waking up or falling asleep
• Sudden muscle weakness in the legs or throughout the body, sometimes triggered by strong emotions (cataplexy-like symptoms)
• Temporary memory loss (amnesia)
• Severe allergic reactions, including hives, swelling of the face or throat, and difficulty breathing

Belsomra can impair your alertness and motor coordination the day after taking it, even if you feel fully awake. This may increase the risk of falls or accidents while driving. You should not drive or engage in activities requiring full mental alertness if you did not get a full night of sleep (at least 7 hours) after taking the medication.

Contraindications

Belsomra is contraindicated in patients with narcolepsy. This medication can cause sudden episodes of muscle weakness (cataplexy-like symptoms) and should not be used by individuals who already experience sudden sleep attacks.

CNS Depressant Effects and Next-Day Impairment

Belsomra is a central nervous system (CNS) depressant that can impair daytime alertness and motor coordination. The risk of next-day impairment, including impaired driving, is higher at the 20 mg dose or if a patient does not get a full night of sleep (at least 7 hours). Patients may feel alert but still have significantly impaired driving skills. This risk is increased when Belsomra is combined with alcohol or other CNS depressants, such as opioids or benzodiazepines.

Complex Sleep Behaviors

Serious injuries and deaths have occurred due to complex sleep behaviors in patients taking sedative-hypnotics. These behaviors occur while the patient is not fully awake and may include:

• Sleepwalking
• Sleep-driving
• Preparing and eating food
• Making phone calls
• Engaging in sexual activity

Patients usually have no memory of these events. Belsomra should be discontinued immediately if a patient experiences any complex sleep behavior.

Worsening of Depression and Suicidality

In patients with primary depressive disorders, worsening of depression and suicidal thoughts or actions have been reported with the use of insomnia medications. Monitoring for any new or worsening symptoms of depression, anxiety, or changes in mood and behavior is recommended.

Sleep Paralysis and Hallucinations

Belsomra can cause symptoms similar to narcolepsy, including sleep paralysis (the inability to move or speak for several minutes while falling asleep or waking up) and hypnagogic or hypnopompic hallucinations. These events can be distressing to patients.

Respiratory Function

The effects of Belsomra on respiratory function should be considered when prescribing to patients with compromised respiratory status. While studies in mild to moderate obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD) did not show significant respiratory depression at standard doses, caution is advised in these populations.

Pregnancy

There are no adequate and well-controlled studies of Belsomra in pregnant women to determine drug-associated risks. In animal studies, no evidence of structural abnormalities was found even at high doses. However, some instances of decreased fetal body weight were noted in animal models when the medication was administered at doses that also caused toxicity in the mother.

Patients who are pregnant or planning to become pregnant are encouraged to discuss the potential risks and benefits of this medication with their healthcare provider. If a patient becomes pregnant while taking Belsomra, they should notify their doctor.

Breastfeeding

It is not known if Belsomra is excreted in human breast milk. Data from animal studies indicate that the drug is present in the milk of lactating rats. Because many medications can pass into breast milk, the potential for adverse effects on a nursing infant is not fully understood.

The decision to use Belsomra while breastfeeding involves weighing several factors:

• The clinical necessity of the medication for the mother.
• The developmental and health benefits of breastfeeding for the infant.
• The potential for side effects in the breastfed child from the medication or from the mother's underlying condition.

Dosage Forms

Belsomra is supplied as a film-coated tablet. This medication is intended for oral use and is typically taken once per night shortly before sleep.

FDA Approval and Indications

Belsomra (suvorexant) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia. It is specifically indicated for adults who experience difficulty with sleep onset (falling asleep) and sleep maintenance (staying asleep).

Controlled Substance Status

Belsomra is regulated as a Schedule IV controlled substance under the Controlled Substances Act. This classification indicates that while the drug has an accepted medical use, it also carries a risk for misuse, abuse, and the development of physical or psychological dependence. Healthcare providers are advised to evaluate the risk of abuse before prescribing and to monitor patients for signs of misuse during treatment.

Safety Warnings and Regulatory Communications

The FDA requires warnings on the labeling of Belsomra regarding the risk of complex sleep behaviors. These behaviors occur when a person is not fully awake and may include:

• Sleepwalking
• Sleep-driving
• Preparing and eating food
• Making phone calls

Because these activities can lead to serious injuries or death, the FDA recommends that the medication be discontinued immediately if a patient experiences any complex sleep behavior. Unlike certain other insomnia medications, Belsomra is an orexin receptor antagonist and was not included in the specific 2019 Boxed Warning mandate that applied to sedative-hypnotics like zolpidem, though it carries similar warnings in its prescribing information.

Additionally, the FDA has issued safety communications regarding the risks of combining sleep medications with other central nervous system (CNS) depressants. Using Belsomra in combination with alcohol or opioid pain medications can lead to profound sedation, respiratory distress, coma, or death.

How Belsomra Works for Insomnia

Belsomra (suvorexant) is an orexin receptor antagonist. It works by blocking the action of orexin, a chemical in the brain that helps keep you awake. By decreasing these wake-promoting signals, Belsomra helps patients transition into sleep and maintain sleep throughout the night.

The medication is approved for the treatment of insomnia characterized by:

• Sleep onset: Difficulty falling asleep at the beginning of the night.
• Sleep maintenance: Difficulty staying asleep or waking up too early and being unable to return to sleep.

Dosing and Administration

For the treatment of insomnia, Belsomra should be taken once per night, within 30 minutes of going to bed. It is important to ensure that at least 7 hours are available for sleep before you need to be active again. Taking the medication with or immediately after a meal may delay the time it takes to work.

If sleep problems persist or worsen after 7 to 10 days of treatment, it may indicate the presence of a primary medical or psychiatric condition that requires further evaluation by a healthcare professional.