Sleeping pills approved by the Food and Drug Administration–Ambien and Lunesta–are getting some negative press these days, and I hear more talk of using off-label medications to treat insomnia. (Off-label meds are drugs approved for the treatment of other disorders.) I’ve blogged about some of these drugs before: trazodone, clonazepam and quetiapine.
Pregabalin is another. Recently I saw a video interview of Thomas Roth, who directs the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, following a professional conference early this month. Asked about insomnia treatments, Roth mentioned two drugs for people with sleep maintenance insomnia (trouble waking up in the middle of the night):
- Low-dose doxepin, a tricyclic antidepressant approved by the FDA for sleep maintenance insomnia under the brand name Silenor in 2010, and
- Pregabalin, an anticonvulsant approved to treat neuropathic pain, epilepsy, and fibromyalgia in the US and for generalized anxiety disorder (GAD) in Europe and Russia.
Lots of people come to The Savvy Insomniac looking for information about sleeping pills and supplements, and sleep maintenance insomnia is the most common type of insomnia problem. So I decided to investigate pregabalin. Here’s what I found out.
Is Pregabalin Effective for Trouble Sleeping?
There haven’t been any controlled trials of pregabalin as a treatment for insomnia per se. But one main side effect of the drug is drowsiness. In chemical structure, pregabalin is similar to GABA, a neurochemical that tranquilizes the brain at night. (But unlike Ambien, Lunesta, and benzodiazepines such as temazepam and clonazepam, pregabalin does not bind directly to GABA or benzodiazepine receptors.)
Insomnia and anxiety are closely linked, and pregabalin inhibits the release of neurotransmitters associated with anxiety. Reviewers looking at the effects of the drug on people with anxiety and insomnia found that the drug improved subjects’ sleep in seven controlled clinical trials.
But the kind of insomnia most often associated with anxiety is trouble getting to sleep at night. Why might pregabalin be effective for people whose problem is that they can’t stay asleep?
The elimination half-life of pregabalin is about 6 hours. So it’s longer lasting than many sleeping pills on the market today, and certainly longer lasting than over-the-counter melatonin supplements. Reviewers of pregabalin’s effects on sleep disturbance associated with other disorders say, based on data from overnight sleep studies, that pregabalin improves sleep and “primarily affects sleep maintenance.”
Is Pregabalin Safe?
Research on pregabalin used in the treatment of other disorders suggests the drug is relatively safe. The two most common side effects of the drug are drowsiness and dizziness. But few randomized, controlled trials have been conducted to determine its long-term safety, though the drug has been on the market since 2005.
Like most prescription sleeping pills, pregabalin is a controlled substance. But it is classified as a Schedule V drug, considered by the FDA and the Drug Enforcement Administration to have a lower potential for abuse and dependence than benzodiazepines like temazepam and clonazepam and Ambien and Lunesta, which are Schedule IV drugs.
If sleep maintenance is your problem and you’re unable to manage it by other means, pregabalin might be worth checking into with your doctor.
If you’ve already tried pregabalin, what effect did it have on your sleep?