Is Lunesta a Controlled Substance? Eszopiclone Schedule, Rules, and Safety Concerns

Lunesta (eszopiclone), available as an oral tablet, is classified as a Schedule IV controlled substance by the federal government. As such, it has the potential to be misused and, over time, to cause physical and psychological dependence. Two major safety concerns associated with Lunesta are next-day impairment and rare (but serious) complex sleep behaviors (e.g., sleep-walking or sleep-driving).

What is Lunesta (Eszopiclone)?

Lunesta is the brand name for eszopiclone, a prescription-only medication used to treat insomnia, a sleep disorder characterized by difficulty falling asleep, difficulty staying asleep, or waking up too early and not returning to sleep [1]. It is also available as a generic drug.

Eszopiclone belongs to a class of medications commonly referred to as “Z-drugs”. These are non-benzodiazepine hypnotics that act as central nervous system depressants [2]. Other medications in this class include zolpidem (brand names include Ambien, Ambien CR, Edluar, Zolpimist), and zaleplon (brand name Sonata). According to Harvard Medical School’s Division of Sleep Medicine, by slowing CNS activity, Lunesta promotes sleep [3].

Who is this page for: This information is intended for individuals who have been prescribed eszopiclone, their family members and caregivers, and others seeking education on sleeping medications and recovery-based sleep safety.

Medical disclaimer: The information contained in this document is intended for educational purposes only and is not a replacement for medical advice from a healthcare provider. Always talk to a qualified healthcare provider before taking, stopping, or changing any medication.

Why is Lunesta Controlled?

Due to its potential for sleeping pill misuse and dependency, Lunesta falls under the category of controlled substances [4]. Some individuals may take higher doses of eszopiclone than what has been prescribed for them or may combine them with alcohol or other sedating drugs. With continued usage, these combinations can increase the risk of physical and psychological dependence [2]. The Mayo Clinic recommends that eszopiclone be used for just 1 or 2 days, and certainly not for more than 1 or 2 weeks.

Healthcare professionals closely monitor eszopiclone use in patients, including those with certain high-risk factors for misuse. High-risk factors may include personal or family histories of substance use disorder, usage of other sedating medications along with eszopiclone, and duration of usage of the drug greater than that recommended [5].

What Schedule is Lunesta? (Schedule IV Overview)

Lunesta has been assigned to Schedule IV of the U.S. Drug Schedule Laws.

Schedule IV drugs have accepted medical uses and lower abuse potential compared to Schedule II or III drugs [4]. However, due to the risk of both physical and psychological dependence associated with Schedule IV drugs, they continue to be regulated [6].

What Does Schedule IV Mean Regarding Prescriptions and Refills?

Classification as a Schedule IV controlled substance affects how Lunesta is prescribed and dispensed to patients.

Federal Refill Limits

Under federal law, Schedule IV drugs can be refilled five times in six months from the original date of the prescription [7]. Beyond the six months, a new prescription must be written. Individual state laws and insurance companies may be stricter than federal guidelines concerning refill regulations.

Practical Implications

Pharmacies may request identification to fill prescriptions for controlled substances and will often scrutinize early refill requests. If a controlled substance has been lost or stolen, the provider prescribing a controlled substance may evaluate the situation closely before replacing the medication.

Safety Concerns and Warnings You Should Know

By knowing which safety alerts are associated with medications such as eszopiclone and other potentially harmful medications, you can reduce the severity of risks and improve the quality of recovery-based sleep care.

Complex Sleep Behaviors

There are some high-risk behaviors associated with the use of medicines such as eszopiclone, which include sleep-driving, sleep-walking, sleep-eating, and others. Patients later have no memory of doing these while affected by the drug.  Injuries and fatalities have occurred. People with these histories should not use eszopiclone again [2].

Next-Day Impairment

Eszopiclone can result in next-day impairment, even if an individual feels alert [3]. This can hinder driving, working, and making sound decisions. The risk of next-day impairment warrants the use of lower initial dosages and adequate time for sleep.

CNS Depression and Potentially Lethal Combinations

Lunesta produces CNS depression. When combined with other CNS depressants such as alcohol, opioids, and sedatives, their effects can compound and create a danger. Combining these drugs can result in respiratory depression, which is shallow and/or slow breathing that can hinder getting enough oxygen and be life-threatening [5].

Misuse, Dependence, and Withdrawal

There is a risk of developing dependence on eszopiclone [6]. In the event an individual ceases using it suddenly, some patients may experience withdrawal symptoms. If an individual needs to stop using eszopiclone, they should consult their healthcare provider for assistance with a tapering schedule.

Guidelines for Safe Use of Lunesta

Safe use of Lunesta is critical for individuals focused on long-term recovery; the list below provides a checklist to follow for safely using eszopiclone:

Safe Use Checklist

• Use eszopiclone only as the prescriber directs.
• Eszopiclone is intended for short-term use of no more than two weeks.
• Do not take more than the prescribed dosage nor use it any more frequently than prescribed.
• Do not consume alcohol with eszopiclone.
• Do not take any other sedative medications unless instructed to by the prescriber.
• Allow a whole night of sleep before driving or working.
• Take eszopiclone shortly before your intended bedtime.
• After taking eszopiclone, do not engage in tasks that require attention and alertness.
• Protect eszopiclone from unauthorized access by storing it securely.
• You must never share your prescription with anyone else.
• Whenever you experience side effects from eszopiclone, most commonly an unpleasant taste in the mouth, headache, and dizziness, contact your prescriber to report your experience. Severe side effects include complex sleep behaviors, allergic reactions, worsening mental health challenges, next-day impairment, and dependence or withdrawal.
• If someone exhibits unusual sleep behavior, they should report it to their prescriber immediately, certainly before using the drug again.

Alternative and Non-Medication Options

For many individuals, non-medication approaches to healthy sleep play a vital role in recovery-focused sleep care. Cognitive behavioral therapy for insomnia, often called CBT-I, is a structured form of talk therapy that focuses on identifying and changing unhelpful thoughts and behaviors related to sleep [3]. 

Some additional supportive methods for recovery-oriented sleep enhancement include mindfulness, the practice of intentionally focusing on the present moment; improved sleep hygiene; and establishing a structure for daily living [1]. A healthcare provider may discuss medication alternatives with patients based on their individual needs.